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PubMed1996

Comparative effects of staphylokinase and alteplase in rabbit bleeding time models.

BACKGROUND: The pathogenesis of bleeding associated with thrombolytic therapy remains largely unknown, although spontaneous bleeding appears to correlate with bleeding time prolongation. Here, the comparative effects on cuticle bleeding times (CBT) and ear puncture bleeding times (EBT) of recombinant staphylokinase (Sak) and alteplase (recombinant tissue-type plasminogen activator, rt-PA) at equivalent doses, alone and in combination with aspirin and heparin, were studied in rabbits. METHODS AND RESULTS: Groups of 4 to 9 rabbits were allocated to one of the 8 following intravenous infusions: saline; aspirin 15 mg/kg and heparin - 100 IU/kg bolus and 10 IU/kg infusion over one hour; 1.5 mg/kg rt-PA; 1.5 mg/kg rt-PA plus aspirin and heparin; 4.5 mg/kg rt-PA; 0.5 mg/kg Sak; 0.5 mg/kg Sak plus aspirin and heparin and 1.5 mg/kg Sak. Bleeding times were determined 30 and 15 min before and 5, 15, 30 and 60 min after the administration over one min of saline, rt-PA or Sak, by simultaneously severing a nail cuticle (CBT) and by puncturing the ear (EBT). Bleeding times were unaffected by saline and by both doses of Sak in monotherapy. Heparin-aspirin and low dose rt-PA significantly lengthened EBT but not CBT. Both CBT and EBT were significantly prolonged (to a mean of > 4 times pretreatment at 5 min) after high-dose rt-PA and after the combined administration of heparin and aspirin with either Sak or tr-PA. rt-PA provoked significantly longer bleeding than Sak in the CBT (p = 0.001; mean estimated difference = 23 min), but not in the EBT. rt-PA but not Sak degraded plasma fibrinogen dose-dependently. CBT correlated inversely with fibrinogen (r= -0.66, p=0.001) but EBT did not. CONCLUSION: At equivalent doses Sak displays a significantly higher fibrin specificity and prolongs bleeding time less than rt-PA, particularly in the nail cuticle bleeding time model in which larger vessels are injured that require fibrinogen for hemostasis.

Animals↗
PubMed2006

The rate of bleeding complications after pharmacologic deep venous thrombosis prophylaxis: a systematic review of 33 randomized controlled trials.

HYPOTHESIS: Major bleeding complications from pharmacologic deep venous thrombosis (DVT) prophylaxis are infrequent. DESIGN: Systematic review of the MEDLINE database from 1965 to August 2005, using the terms DVT, prophylaxis, general surgery, and heparin. SETTING AND PATIENTS: Randomized controlled trials evaluating pharmacologic DVT prophylaxis in patients undergoing general surgery. MAIN OUTCOME MEASURES: Eight complication categories: injection site bruising, wound hematoma, drain site bleeding, hematuria, gastrointestinal tract bleeding, retroperitoneal bleeding, discontinuation of prophylaxis, and subsequent operation. RESULTS: Fifty-two randomized controlled trials studied DVT prophylaxis; 33 randomized controlled trials with 33 813 patients undergoing general surgery evaluated pharmacologic prophylaxis and quantified bleeding complications. Of the minor complications, injection site bruising (6.9%), wound hematoma (5.7%), drain site bleeding (2.0%), and hematuria (1.6%) were most common. Major bleeding complications, such as gastrointestinal tract (0.2%) or retroperitoneal (<0.1%) bleeding, were infrequent. Discontinuation of prophylaxis occurred in 2.0% of patients and subsequent operation in less than 1% of patients. When analyzed by high- vs low-dose unfractionated heparin, the lower dose had a smaller rate of discontinuation of prophylaxis (P = .02) and subsequent operation (P = .06). CONCLUSIONS: Knowledge of bleeding complication rates is important for surgeons because DVT prophylaxis may soon be implemented by Medicare as a quality measure. This level 1 evidence report shows that bleeding complications requiring a change in care occur less than 3% of the time and seem reduced with lower-dose prophylaxis. Given these findings, most patients undergoing general surgery could receive pharmacologic prophylaxis safely.

Anticoagulants↗
PubMed2004

Hormone replacement therapy in postmenopausal women: endometrial hyperplasia and irregular bleeding.

BACKGROUND: The decline in circulating oestrogen around the time of the menopause often induces unacceptable symptoms that affect the health and well being of women. Hormone replacement therapy (both unopposed oestrogen and oestrogen and progestogen combinations) is an effective treatment for these symptoms. In women with an intact uterus, unopposed oestrogen may induce endometrial stimulation and increase the risk of endometrial hyperplasia and carcinoma. The addition of progestogen reduces this risk but may cause unacceptable symptoms, bleeding and spotting which can affect adherence to therapy. OBJECTIVES: The objective of this review is to assess which hormone replacement therapy regimens provide effective protection against the development of endometrial hyperplasia and/or carcinoma with a low rate of abnormal vaginal bleeding. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group trials register (searched January 2003), The Cochrane Library (Issue 2, 2003), MEDLINE (1966 to January 2003), EMBASE (1980 to January 2003), Current Contents (1993 to January 2003), Biological Abstracts (1969 to 2002), Social Sciences Index (1980 to January 2003), PsycINFO (1972 to February 2003) and CINAHL (1982 to January 2003). The search strategy was developed by the Cochrane Menstrual Disorder and Subfertility Group. Attempts were also made to identify trials from citation lists of review articles and drug companies were contacted for unpublished data. In most cases, the corresponding author of each included trial was contacted for additional information. SELECTION CRITERIA: The inclusion criteria were randomised comparisons of unopposed oestrogen therapy, combined continuous oestrogen-progestogen therapy and sequential oestrogen-progestogen therapy with each other and placebo administered over a minimum treatment period of six months. Trials had to assess which regimen was the most protective against the development of endometrial hyperplasia/carcinoma and/or caused the lowest rate of irregular bleeding. DATA COLLECTION AND ANALYSIS: Sixty RCTs were identified. Of these 23 were excluded and seven remain awaiting assessment. The reviewers assessed the thirty included studies for quality, extracted the data independently and odds ratios for dichotomous outcomes were estimated. Outcomes analysed included frequency of endometrial hyperplasia or carcinoma, frequency of irregular bleeding and unscheduled biopsies or dilation and curettage, and adherence to therapy. MAIN RESULTS: Unopposed moderate or high dose oestrogen therapy when compared to placebo was associated with a significant increase in rates of endometrial hyperplasia with increasing rates at longer duration of treatment and follow up. Odds ratios ranged from (1 RCT; OR 5.4, 95% CI 1.4 to 20.9) for 6 months of treatment to (4 RCTs; OR 9.6, 95% CI 5.9 to 15.5) for 24 months treatment and (1 RCT; OR 15.0, 95% CI 9.3 to 27.5) for 36 months of treatment with moderate dose oestrogen (in the PEPI trial, 62% of those who took moderate dose oestrogen had some form of hyperplasia at 36 months compared to 2% of those who took placebo). Irregular bleeding and non adherence to treatment were also significantly more likely under these unopposed oestrogen regimens that increased bleeding with higher dose therapy. Although not statistically significant, there was a 3% incidence (2 RCTs) of hyperplasia in women who took low dose oestrogen compared to no incidence of hyperplasia in the placebo group. The addition of progestogens, either in continuous combined or sequential regimens, helped to reduce the risk of endometrial hyperplasia and improved adherence to therapy. At longer duration of treatment, continuous therapy was more effective than sequential therapy in reducing the risk of endometrial hyperplasia. There was evidence of a higher incidence of hyperplasia under long cycle sequential therapy (progestogen given every three months) compared to monthly sequential therapy (progestogen given every month). No increase in endometrial cancer was seen in any of t in any of the treatment groups during the duration (maximum of six years) of these trials. During the first year of therapy irregular bleeding and spotting was more likely in continuous combined therapy than sequential therapy. However, during the second year of therapy bleeding and spotting was more likely under sequential regimens. REVIEWERS' CONCLUSIONS: There is strong and consistent evidence in this review that unopposed oestrogen therapy, at moderate and high doses, is associated with increased rates of endometrial hyperplasia, irregular bleeding and consequent non adherence to therapy. The addition of oral progestogens administered either sequentially or continuously is associated with reduced rates of hyperplasia and improved adherence to therapy. Irregular bleeding is less likely under sequential than continuous therapy during the first year of therapy but there is a suggestion that continuous therapy over long duration is more protective than sequential therapy in the prevention of endometrial hyperplasia. Hyperplasia is more likely when progestogen is given every three months in a sequential regimen compared to a monthly progestogen sequential regimen.

Endometrial Hyperplasia↗
PubMed2000

Progesterone/progestogen releasing intrauterine systems versus either placebo or any other medication for heavy menstrual bleeding.

BACKGROUND: Heavy menstrual bleeding (HMB) is an important cause of ill health in women and it accounts for 12% of all gynaecology referrals in the UK. Heavy menstrual bleeding is clinically defined as greater than, or equal to, 80mls blood loss per menstrual cycle but women may complain of excessive bleeding when their blood loss is less than 80ml. Hysterectomy is often used to treat women with this complaint but medical therapy may be a successful alternative. The intrauterine coil device was originally developed as a contraceptive but the addition of uterine relaxing hormones, or progestogens, to these devices resulted in a large reduction in menstrual blood loss. Case studies of 2 types of progesterone/progestogen releasing systems, Progestasert and Mirena, report reductions of up to 90% and dysmenorrhoea may be improved. Insertion, however, may be regarded as invasive by some women affecting its acceptability as a treatment and frequent intermenstrual bleeding and spotting is likely during the first few months. OBJECTIVES: To determine the effectiveness and acceptability of progesterone/progestogen-releasing intrauterine devices in achieving a reduction in heavy menstrual bleeding. SEARCH STRATEGY: All studies which might describe randomised controlled trials of progesterone/progestagen-releasing intrauterine devices for the treatment of heavy menstrual bleeding were obtained by electronic searches of the MEDLINE 1966-1999, EMBASE 1980-1999 databases and the Cochrane Library. Companies producing progestogen releasing intrauterine devices and experts in the field were contacted for information on published and unpublished trials. SELECTION CRITERIA: Randomised controlled trials in women of reproductive age treated with progesterone/progestogen-releasing intrauterine devices versus no treatment, placebo, or other medical or surgical therapy for heavy menstrual bleeding within either the primary care, family planning or specialist clinic setting were eligible for inclusion. Women with postmenopausal bleeding, intermenstrual or irregular bleeding, or pathological causes of heavy menstrual bleeding were excluded. DATA COLLECTION AND ANALYSIS: Potential trials were independently assessed by three reviewers and five trials met the criteria for inclusion in the review. The reviewers extracted the data independently and data were pooled where appropriate. Odds ratios for dichtomous outcomes and weighted mean differences for continuous outcomes were estimated from the data. The primary outcome was reduction in menstrual blood loss but incidence of side effects, changes in quality of life and satisfaction and acceptability measures were also assessed. MAIN RESULTS: Progesterone/progestogen-releasing intrauterine systems have not been compared to placebo or no treatment. Progestasert has been compared to a number of different medical therapies in one small study but no conclusions can be made about effectiveness. The levonorgestrel-releasing intrauterine device (LNG IUS) has been compared to oral cyclical norethisterone (NET) administered on days 5-26 in one trial and was significantly more effective although there was a large reduction from baseline in both groups and these differences were not perceived by the women undergoing the treatment. Some side effects were more common in the LNG IUS group but a significantly greater proportion of women in this group were satisfied and willing to continue with their treatment. In one trial of women awaiting hysterectomy where the LNG IUS was compared with a control group taking their existing medical therapy, a higher proportion of the women in the former group cancelled their planned surgery after 6 months of treatment. The levonorgestrel-releasing intrauterine device has been compared to a surgical procedure (transcervical resection of the endometrium (TCRE)) in two trials. (ABSTRACT TRUNCATED)

Female↗
PubMed2003

Surgery versus medical therapy for heavy menstrual bleeding.

BACKGROUND: Heavy menstrual bleeding significantly impairs the quality of life of many otherwise healthy women. Perception of heavy bleeding is highly subjective and management of the condition usually depends upon the degree of bleeding and discomfort found acceptable by the individual woman. Medical treatment options include oral medications and a hormone-releasing intrauterine system (LNG-IUS). Surgical options include conservative surgery (uterine resection or ablation) and hysterectomy. OBJECTIVES: To compare the effectiveness, safety and acceptability of surgery versus medical therapy for heavy menstrual bleeding. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group trials register (October 2002), Cochrane Controlled Trials Register (Issue 3, 2002), MEDLINE (1966 to October 2002), EMBASE (1980 to October 2002), Current Contents (1993 to week 45, 2002), Biological Abstracts (1969 to September 2002), PsycINFO (1985 to October 2002), CINAHL (1982 to October 2002), and reference lists of articles. We also contacted pharmaceutical companies and experts in the field. SELECTION CRITERIA: Controlled randomised trials comparing surgery (conservative surgery and hysterectomy) versus medical therapy (both oral and intrauterine) for heavy menstrual bleeding DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed trials for quality and extracted data, calculating odds ratios for dichotomous outcomes and weighted mean differences for continuous outcomes. MAIN RESULTS: Five trials met the inclusion criteria. They randomised 625 women, 311 to receive surgery and 314 to receive medical treatment. One trial compared endometrial resection with oral medication: surgery proved significantly more effective in controlling bleeding (OR 10.62, 95% CI 5.30 to 21.27) and significantly less likely to cause side effects (OR 0.15, 95% CI 0.07 to 0.31). In the other four trials the medical arms received LNG-IUS and the surgical arms received conservative surgery or hysterectomy. At one year no statistically significant difference was shown between LNG-IUS and any surgical treatment in satisfaction rates or quality of life, though conservative surgery was significantly less likely to cause adverse effects (OR 0.24, 95% CI 0.11 to 0.49). Although conservative surgery was significantly more effective than LNG-IUS in controlling bleeding at one year (OR 3.99, 95% CI 1.53 to 10.38), a small trial showed no significant difference between the treatments at two and three years. Hysterectomy stopped all bleeding but caused serious complications for some women. REVIEWER'S CONCLUSIONS: Surgery reduces menstrual bleeding at one year more than medical treatments, but LNG-IUS appears equally beneficial in improving quality of life and may control bleeding as effectively as conservative surgery over the long term. Oral medication suits a minority of women long term.

Antifibrinolytic Agents↗
PubMedDate not supplied

Terlipressin in bleeding esophageal varices: a placebo-controlled, double-blind study.

The effect of terlipressin (N-alpha-triglycyl-8-lysine-vasopressin) in bleeding esophageal varices was evaluated in a prospective placebo-controlled study. Fifty bleeding episodes from esophageal varices in 34 patients were randomized. Standard therapy with transfusions, fluid and electrolyte correction, and lactulose was performed in both groups. Balloon tamponade was used in 20 bleeding episodes in the terlipressin group and in 19 bleeding episodes in the control group. In the terlipressin group, hemorrhage was controlled in all bleeding episodes (25/25) whereas in the placebo group, only 20 of 25 bleeding episodes could be stopped within 36 hr (p less than 0.05). Sclerotherapy was performed in five bleeding episodes in the terlipressin group and in seven bleeding episodes in the placebo group. Treatment failures, including patients who required sclerotherapy, occurred in five bleedings in the terlipressin group and in 12 in the control group (p less than 0.05). The hospital mortality rate was 12% (3/25) in the terlipressin group and 32% (8/25) in the control group. Patients in the terlipressin group required fewer transfusions, the balloon needed to be inflated for a shorter time and the duration of bleeding was shorter than in the control group. However, these differences were not significant. These data do not allow conclusions concerning monotherapy with terlipressin, but they indicate that the addition of terlipressin to standard therapy may increase the control rate in acute variceal hemorrhage.

Adult↗
PubMed1991

Incidence and clinical risk factors for bleeding and thrombotic complications in myeloproliferative disorders. A retrospective analysis of 260 patients.

Bleeding and thrombosis are frequent complications in myeloproliferative disorders (MPD) and are associated with severe organ damage and a high mortality. Elevated platelet count, elevated hematocrit, and patient age are regarded as risk factors for bleeding and thromboembolic events in MPD, although the significance of these parameters was not confirmed by clinical studies. We retrospectively analyzed vascular complications in 260 patients with MPD and tried to identify parameters predictive for bleeding and thrombembolic events. Our cohort consisted of 115 patients with chronic myeloid leukemia (CML), 84 patients with polycythemia vera (PV), 26 with essential thrombocythemia (ET), 25 with osteomyelofibrosis (OMF), and 10 patients with unclassifiable MPD. During a median follow-up period of 31 months, 126 patients with chronic MPD suffered bleeding or thrombotic events. Bleeding was observed in 57% of patients with OMF, 23% with PV, 20% with chronic phase CML, and 16% with ET. Thrombotic events were most common in patients with PV (36% of patients), followed by ET, OMF, and chronic phase CML (20%, 17%, and 6% of patients, respectively). Recurrent thrombotic episodes frequently occurred in patients with PV and ET, whereas patients with OMF often had more than one bleeding event. Thirty patients died of thrombohemorrhagic complications during follow-up. Multivariate analysis, including all patients with chronic MPD, revealed that elevated red blood cell count, higher hemoglobin level, and increased percentage of segmented neutrophils at the time of diagnosis were associated with thrombosis, whereas patients with bleeding complications were characterized by low red cell count, lower hemoglobin, and a lower percentage of segmented neutrophils. However, when analyzed by MPD subgroup, none of these parameters retained a predictive value for bleeding or thrombotic events. Moreover, elevated platelet count and patient age were not risk factors for bleeding complications. Thrombotic events were less frequent in patients below the age of 40, and were increased in patients aged 70 and above. However, this was primarily due to the high percentage of elderly patients in subgroups mainly affected by thrombosis (PV and ET). In most MPD subgroups, the rate of bleeding and thrombosis was highest just before and during the first months after diagnosis, and declined thereafter. Thrombohemorrhagic complications were less frequent after phlebotomy in PV and after therapy with alkylating agents in CML. The institution of cytoreductive therapy soon after the diagnosis was made may explain the reduced incidence of complications later in the disease. We conclude that morbidity and mortality from thrombohemorrhagic complications are high in myeloproliferative disorders.(ABSTRACT TRUNCATED AT 400 WORDS)

Bloodletting↗
PubMed1999

When are children diagnosed as having severe haemophilia and when do they start to bleed? A 10-year single-centre PUP study.

UNLABELLED: The aim of this single-centre study was to obtain data prospectively on when children are diagnosed as having severe haemophilia and when they start to bleed. Results of this 10-year PUP study suggest that severe haemophilia is nowadays diagnosed much earlier than in the Sixties. Patients with severe haemophilia (n = 37: FV III <0.01 U/ml) start to bleed at very different ages. While 44% of patients have their first bleeding episode within the first year of life, others do not bleed before the age of four. The onset of joint bleedings generally occurs about half a year later than other types of bleeding. While half our patients developed their first bleeding by the age of 1.22 years, the mean age for the first joint bleeding was 1.91 years. CONCLUSION: Early-onset prophylactic therapy can prevent damage to the joints, but for rational therapy the age at onset of bleeding must also be taken into account. A non-bleeding child does not benefit from prophylactic treatment.

Age of Onset↗
PubMed1992

Objective evidence of aspirin use in both ulcer and nonulcer upper and lower gastrointestinal bleeding.

To obtain the best evidence for nonsteroidal anti-inflammatory drug (NSAID) use in gastrointestinal (GI) bleeding, a detailed patient history was supplemented with objective tests of aspirin use, i.e., high-performance liquid chromatography of plasma and platelet cyclo-oxygenase inhibition, which detect aspirin intake within 24 and 120 hours, respectively. Seventy-one patients consecutively admitted for upper or lower GI bleeding and 138 age- and sex-matched controls were studied. Five bleeders were excluded for confounding factors, e.g., warfarin. Of the other 66 bleeders, 45 had upper GI bleeding (28 from peptic ulcer, 14 from duodenal ulcer, and 14 from gastric ulcer) and 21 lower GI bleeding. Evidence of current NSAID use (of which 89% was aspirin) was found in 80% of bleeders vs. 24.3% of controls (P less than 0.0001), for an odds ratio of 13.7 (95% confidence interval, 6.39-27.27). The cyclo-oxygenase test uncovered 21.5% more aspirin users than history alone. Severity of bleeding was not different in acetylsalicylic acid users. The surprisingly high association of current intake of NSAIDs, especially aspirin, with nonulcer GI bleeding including colonic bleeding, changes the conventional view of the following hierarchy of the risk: NSAID----peptic ulcer----bleeding to: NSAIDs----GI bleeding. This view has important implications for current ulcer cotherapy prophylactic strategies, which could fail to prevent greater than 50% of GI bleeding episodes.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2005

Management of delayed visceral arterial bleeding after pancreatic head resection.

Despite low mortality, postoperative complications are still relatively frequent after pancreatic head resection. The occurrence of delayed visceral arterial bleeding from erosions or pseudoaneurysms of branches of the celiac trunk or from the stump of the gastroduodenal artery is a rare but life-threatening complication and is probably underreported in the literature. During a 10-year period, we diagnosed and treated 12 patients (three referred from other hospitals) with severe visceral arterial bleeding, presenting 7 to 85 days after pancreatic head resection. Clinical presentation was gastrointestinal bleeding (seven patients) or abdominal bleeding (five patients). The bleeding source was identified by angiography in 10 of the 12 cases. Definitive bleeding control was achieved by angiography in six of the 12 patients (stent 2, coiling 4), or by surgery in five patients. None of the six patients with successful angiographic intervention required further surgery for bleeding control. One patient died due to hemorrhage before bleeding was controlled. Median transfusion requirement was 12.5 (range 3-37) units. Of five patients with interventional or surgical occlusion of the common hepatic artery, three developed hepatic abscesses and two had complications of the hepaticojejunostomy. One of those five patients died four months after definitive bleeding control because of recurrent hepatic abscesses. All other patients eventually recovered completely. We conclude that delayed arterial bleeding from visceral arteries is a rare but life-threatening complication after pancreatic head resection. Angiographic stenting with preservation of hepatic blood flow, if technically possible, represents the best treatment option.

Aged↗
PubMed2006

Correlates of bleeding events among moderate- to high-risk patients undergoing percutaneous coronary intervention and treated with eptifibatide: observations from the PROTECT-TIMI-30 trial.

OBJECTIVES: We aimed to identify correlates of Thrombolysis In Mycocardial Infarction (TIMI) major/minor bleeding among eptifibatide-treated patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: Evaluation of bleeding predictors among patients treated with glycoprotein IIb/IIIa receptor inhibition might aid in the identification of targets to reduce bleeding risk. METHODS: Data were analyzed from 567 moderate- to high-risk PCI patients with non-ST-segment elevation acute coronary syndrome (NSTEACS) treated with eptifibatide/reduced-dose unfractionated heparin or eptifibatide/reduced-dose enoxaparin enrolled in the Randomized Trial to Evaluate the Relative Protection Against Post-PCI Microvascular Dysfunction and Post-PCI Ischemia Among Anti-Platelet and Anti-Thrombotic Agents-Thrombolysis In Myocardial Infarction-30 (PROTECT-TIMI-30). RESULTS: The incidence of significant bleeding was 3.2% with a median time to event of 7.0 h after the first eptifibatide bolus. Increased age was the only independent correlate of bleeding events. Among patients with reduced creatinine clearance (CrCl), lack of adjustment of the maintenance infusion for CrCl < or =50 ml/min occurred frequently (15 of 33 patients, or 45%) and was associated with a high rate of bleeding (20%). The association of CrCl with bleeding appeared to be largely mediated by the incorporation of age in the estimation of CrCl. Patient gender, Cr, weight, and the peak activated clotting time were not associated with bleeding. CONCLUSIONS: Among NSTEACS PCI patients treated with eptifibatide, increased age was a significant correlate of bleeding events and appeared to explain the association between low CrCl and bleeding. The more widespread use of CrCl or other estimates of renal function over Cr may lead to more appropriate dose adjustments of eptifibatide.

Acute Disease↗
PubMed1999

The World Health Organization multinational study of breast-feeding and lactational amenorrhea. IV. Postpartum bleeding and lochia in breast-feeding women. World Health Organization Task Force on Methods for the Natural Regulation of Fertility.

OBJECTIVE: To describe and compare the duration of lochia in seven groups of women; to investigate the occurrence of a possible "end-of-puerperium" bleeding episode; and to determine the frequency of bleeding episodes before postpartum day 56, which applies to the practice of the lactational amenorrhea method of contraception. DESIGN: Prospective longitudinal study with fortnightly follow-up, beginning within 7 days of delivery. SETTING: Five developing and two developed countries. PATIENT(S): Four thousand one hundred eighteen breast-feeding women. INTERVENTION(S): Postpartum lochia and all days of bleeding per vaginam were recorded. MAIN OUTCOME MEASURE(S): Duration of lochia, frequency of an end-of-puerperium bleeding episode, and frequency of postlochia bleeding episodes within 56 days of delivery. RESULT(S): The median duration of lochia was 27 days; it varied significantly among the centers (range, 22-34 days). In 11% of the women, lochia lasted >40 days. An end-of-puerperium bleeding episode around the 40th day postpartum was reported by 20.3% of the women. Bleeding within 56 days of delivery (separated from lochia by at least 14 days) occurred in 11.3% of the women and usually was followed by a confirmatory bleeding episode 21-70 days later. CONCLUSION(S): The duration of lochia varied significantly among the study populations, and long durations were not unusual. The significance of the end-of-puerperium bleeding episode is unknown. Most users of the lactational amenorrhea method will not experience a postlochia bleeding episode before postpartum day 56.

Amenorrhea↗
PubMed2004

Optimal injection volume of epinephrine for endoscopic prevention of recurrent peptic ulcer bleeding.

BACKGROUND: Although the initial rate of hemostasis achieved by endoscopic epinephrine injection for peptic ulcer bleeding is high, bleeding recurs in 14.6% to 35.5% of patients. The aim of this study was to compare rates of recurrent bleeding after endoscopic injection of two different volumes of epinephrine in patients with peptic ulcer bleeding. METHODS: A total of 72 patients with peptic ulcer with active bleeding or a non-bleeding visible vessel were randomly assigned to 15 to 25 mL or 35 to 45 mL injections of a 1:10,000 solution of epinephrine. RESULTS: The two groups were similar with respect to all background variables. The mean volume of epinephrine injected was 19.4 mL: 95% CI [18.7, 20.1] in the 15 to 25 mL group and 41.1 mL: 95% CI [40.0, 42.2] in the 35 to 45 mL group. Initial hemostasis was achieved in 35 of 36 patients (97.2%) in the 15 to 25 mL group and in all 36 patients in the 35 to 45 mL group. The 35 to 45 mL volume was significantly more effective in preventing recurrent bleeding than the 15 to 25 mL volume (0% vs. 17.1%; p < 0.05). For ulcers in the gastric body, the 35 to 45 mL volume was significantly more effective in preventing recurrent bleeding than the 15 to 25 mL volume (0% vs. 31.6%; p = 0.003). For ulcers in other locations, including the gastric antrum and the duodenum, there were no significant differences in the rate of recurrent bleeding between the two groups. CONCLUSIONS: Injection of 35 to 45 mL of a 1:10,000 solution of epinephrine is more effective than injection of 15 to 25 mL of the same solution for prevention of recurrent bleeding from ulcers in the body of the stomach.

Dose-Response Relationship, Drug↗
PubMed1996

Gastrointestinal bleeding after hepatic transcatheter arterial embolization in patients with hepatocellular carcinoma.

BACKGROUND: Transcatheter arterial embolization is a popular palliative treatment for patients with hepatocellular carcinoma, but the incidence of post-treatment gastrointestinal bleeding is not well-defined. METHODS: We retrospectively analyzed 206 patients with hepatocellular carcinoma who received transcatheter arterial embolization and compared them with 193 patients with hepatocellular carcinoma who underwent angiography along. RESULTS: Twenty-three episodes (8.5%) of gastrointestinal bleeding occurred within 3 months of hepatic transcatheter arterial embolization following 269 procedures involving 206 patients with hepatocellular carcinoma. Eight episodes (3.0%) of esophageal variceal bleeding and 15 episodes (5.5%) of nonvariceal bleeding were found. The sites of the nonvariceal bleeding episodes were the stomach (n = 7), duodenum (n = 5), and colon (n = 3). When compared with other sources, bleeding from esophageal varices took place earlier, required intensive treatment, and led to a higher mortality. Among another 193 patients with hepatocellular carcinoma who received angiography only, 6 patients developed gastrointestinal bleeding within 3 months (3.1%), and all bled from esophageal varices. CONCLUSIONS: This study suggests that esophageal variceal bleeding may occur after both angiography and transcatheter arterial embolization. Nonvariceal bleeding episodes, which were usually milder than episodes of variceal bleeding, may be related to the embolization procedure itself.

Adolescent↗
PubMed1998

Injection sclerotherapy for variceal bleeding in patients with hepatocellular carcinoma: cyanoacrylate versus sodium tetradecyl sulphate.

BACKGROUND: Patients with hepatocellular carcinoma complicated by variceal bleeding have a very limited life span. Recurrent bleeding after endoscopic injection sclerotherapy is common. Our aim was to compare the efficacy of endoscopic injection of cyanoacrylate versus sodium tetradecyl sulphate in the control of variceal bleeding in patients with hepatocellular carcinoma. METHODS: Patients known to be suffering from inoperable hepatocellular carcinoma who presented with upper gastrointestinal bleeding underwent endoscopy within 24 hours of admission. After bleeding from esophageal varices was confirmed, they were randomized to receive endoscopic injections of either cyanoacrylate (1:1 mixture with Lipoidol) or sodium tetradecyl sulphate (1.5%). Injection were given intravariceally into each visible column for up to four injections for cyanoacrylate and up to 30 mL for sodium tetradecyl sulphate. RESULTS: A total of 50 patients were recruited for this study with 25 cases randomized to each endoscopic treatment group. Control of acute bleeding failed in four patients (16%) in both treatment groups, and two patients in each group died during the index episode of bleeding. Six patients (24%) in the cyanoacrylate group and four patients (16%) in the sodium tetradecyl sulphate group developed recurrent bleeding during their hospital stay (p = 0.48). Recurrent bleeding within 30 days after the index episode of bleeding was documented in seven patients (28%) who received cyanoacrylate injection and five patients (20%) who received sodium tetradecyl sulphate injection (p = 0.51). Median survival in the cyanoacrylate group was 16 days (range 1 to 485 days) and that of the sodium tetradecyl sulphate group was 13 days (range 1 to 407 days). There was no difference in cumulative survival between the two groups as analyzed by the Kaplan-Meier method. Patients with portal vein thrombosis had a higher risk of recurrent hemorrhage. Patients with Child's C liver disease had a significantly higher mortality. CONCLUSIONS: Cyanoacrylate did not improve the outcome of hepatocellular carcinoma patients with variceal hemorrhage.

Carcinoma, Hepatocellular↗
PubMed1999

Clinical usefulness of 3% hydrogen peroxide in acute upper GI bleeding: a pilot study.

BACKGROUND: A major problem in the endoscopic management of acute upper gastrointestinal (GI) bleeding is the presence of blood and clots overlying the bleeding source, preventing visualization of the lesion. A simple alternative is to alter the characteristics of blood such that it not only becomes easier to remove but also becomes translucent. We report the results of a pilot study on the use of hydrogen peroxide in patients with acute upper GI bleeding. METHODS: Patients with acute upper GI bleeding were studied if the presence of blood or clots obscured the site of bleeding. The potential site of bleeding was initially sprayed with 200 mL water and then with 200 mL 3% hydrogen peroxide mixed with simethicone. RESULTS: In 6 patients with acute upper GI bleeding, hydrogen peroxide spray resulted in good to excellent visualization of the bleeding source. Hemostasis occurred in 2 patients who were actively bleeding. There were no adverse effects or complications. CONCLUSIONS: Hydrogen peroxide significantly enhanced clot dissolution and endoscopic visualization in patients with acute upper GI bleeding.

Acute Disease↗
PubMed1999

Gestational bleeding, bacterial vaginosis, and common reproductive tract infections: risk for preterm birth and benefit of treatment.

OBJECTIVE: To examine associations between bacterial vaginosis and other prevalent lower genital tract infections and clinically recognized first-trimester bleeding; possible independent and joint effects of gestational bleeding and bacterial vaginosis or other prevalent infections on preterm birth and premature rupture of membranes; and effects of antimicrobial treatment on reducing risks of preterm birth among these women. METHODS: A secondary analysis was conducted of 1100 pregnant women enrolled in a prospective observational study that examined the effects of standardized diagnosis and treatment of lower genital tract infections to prevent preterm birth. RESULTS: Sixty percent of women with first-trimester bleeding had one or more study infections detected at the initial examination. First-trimester bleeding was associated independently with the presence of bacterial vaginosis (odds ratio [OR] 1.5, 95% confidence interval [CI] 1.0, 2.3), Trichomonas vaginalis (OR 2.3, 95% CI 1.3, 4.2), and Chlamydia trachomatis (OR 2.7, 95% CI 1.4, 5.1). Preterm birth was increased among women with first-trimester bleeding and bacterial vaginosis (relative risk [RR] 4.4, 95% CI 2.0, 9.5) and bacterial vaginosis and T vaginalis (RR 3.0, 95% CI 1.0, 8.8). Systemic antimicrobial treatment reduced the rate of preterm birth among women with bacterial vaginosis without first-trimester bleeding (RR 0.37, 95% CI 0.16, 0.88). Treatment of women with both first-trimester bleeding and bacterial vaginosis reduced preterm birth (RR 0.52, 95% CI 0.18, 1.55), but not significantly. CONCLUSION: First-trimester bleeding was increased among women with bacterial vaginosis, T vaginalis, C trachomatis, and combinations of these infections. Women with bacterial vaginosis who also experienced first-trimester bleeding were at heightened risk for preterm birth. Treatment of studied infections reduced significantly the risks of preterm birth among women without first-trimester bleeding.

Adolescent↗
PubMed1998

Analysis of the treatment effect on recurrent bleeding and death in patients with cirrhosis and esophageal varices: multistage competing-risks model compared to conventional methods. The Copenhagen Esophageal Varices Sclerotherapy Project.

BACKGROUND/AIMS: Multiple recurrences of bleeding with high mortality in cirrhosis with esophageal varices have been inadequately analyzed in previous trials. We propose analysis by the multistage competing-risks model, specifying the effect on overall mortality as an effect on mortality during bleeding, rate of cessation of bleeding, mortality rate without bleeding, and rate of rebleeding. METHODS: The Copenhagen Esophageal Varices Project enrolled patients after first bleeding and randomized 94 to usual treatment and 93 to sclerotherapy as supplement. During 9-52 months of follow-up, rebleeding occurred in 49 and 42, and death in 68 and 60 patients, respectively. The proportional hazards regression model (Cox model) was used for reanalysis both by the multistage competing-risks model and by conventional analysis for overall mortality and rate of first rebleeding. In the multistage model, time zero was at entry to any new disease stage, of which the first four were analyzed - two bleeding stages and two bleeding-free stages. RESULTS: The conventional analysis showed a reduction of overall mortality rate in the sclerotherapy group of borderline significance, but no effect on rate of rebleeding. The multistage model indicated that sclerotherapy reduced the rate of rebleeding late in the disease course, and particularly after the first rebleeding. Rate of cessation of bleeding and mortality rates during bleeding and without bleeding were not affected by sclerotherapy. CONCLUSIONS: Conventional analysis may give misleading conclusions, which might be avoided by applying the multistage model. The effect of sclerotherapy on overall mortality may be ascribed entirely to the reduced rate of rebleeding.

Denmark↗