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PubMed1993

Collagen plug hemostatic closure of femoral arterial puncture sites following implantation of intracoronary stents.

Recently a new adjunct to achieving arterial hemostasis has been developed. The device consists of a purified bovine collagen plug which when inserted adjacent to the arterial wall induces the formation of a hemostatic cap directly over the arterial puncture. We have utilized collagen plug hemostasis in 32 patients on 35 occasions undergoing implantation of intracoronary stents while attempting to maintain continuous full anticoagulation. Initial hemostasis was successfully achieved in all patients. Moderate sized (5 to 10 cm) hematomas were noted in 4 patients and large hematomas (> 10 cm) in 3, of whom 2 required vascular repair and transfusion. One patient developed a purulent discharge from the puncture site which resolved with a brief course of antibiotics. No patient suffered femoral arterial occlusion, distal embolization, or venous thrombosis. There were no long term access site problems at a mean follow up of 6 months. Repeat catheterization utilizing the same femoral artery was performed in 16 patients without difficulty. In five of these patients angiography was performed early after stent implantation without discontinuation of full anticoagulation and collagen closure was utilized a second time. Collagen plug hemostasis is feasible after coronary stenting, may allow more aggressive anticoagulation than might otherwise be achieved, and may facilitate angiographic restudy early after stenting without the need to discontinue anticoagulation.

Aged↗

PubMed1980

Interaction of the absorbable hemostatic agent (IP760) with aminoglycosidic antibiotics.

The linear, crosslinked amylose-succinate hemostatic agent, IP760, has been evaluated for its interaction with aminoglycosidic antibiotics. The highly structured polymer appears to act as a cationic exchange resin which binds the basic aminoglycosides. Binding of these agents to IP760 is reversed by increased pH and/or increased ionic strength. Dialysis experiments demonstrated that 85 and 90% of the bound gentamicin was released at pH 7.5 and 8.0, respectively, over a period of 36 hr. Formation of the IP760-antibiotic complexes suggests potential medicinal use for hemostatis and slow release of the antibiotic for prophylaxis of postsurgical contamination or infection

Absorption↗

PubMed1996

Hemostatic methods for the management of spleen and liver injuries.

The spleen and liver are the most frequently injured organs during blunt and penetrating abdominal trauma. Emergency laparotomy is crucial for early control of bleeding and to prevent "secondary" injury as a result of physiologic splanchnic vasoconstriction and free oxygen radicals. Altogether 98 patients with spleen and liver injuries were treated over an 8-year period. Primary orthotopic spleen preservation could be achieved in 46 of 63 patients. In 58 patients with hepatic trauma, hemostatic treatment was chosen based on the severity of the injury. Nonoperative management was used for four splenic and seven hepatic trauma patients. The most commonly used techniques were fibrin sealing, suturing, and débridement for hepatic injury and mesh splenorrhaphy, fibrin glue, and partial resection with a TA stapler for splenic injury. The death of patients with complex injuries was mainly due to preclinical massive blood loss and multiple organ failure.

Hemostatic Techniques↗

PubMed2006

Laparoscopically assisted liver biopsy with a hemostatic plug.

BACKGROUND: Percutaneous and open liver biopsies are routine procedures for diagnosing liver pathology. However, the procedure can carry significant morbidity and even mortality, especially in the event of an uncorrectable coagulopathy or a highly vascular tumor. METHODS: A technique described for use in such circumstances involves laparoscopy for identification of the lesion to be biopsied, enables placement of a gelatin hemostatic plug in the core biopsy tract, and confirms hemostasis after percutaneous plugging of the biopsy site. RESULTS: The technique was successfully used for seven patients: six patients with hepatic coagulopathy and one with a highly vascular liver tumor. There were no complications during either the intra- or postoperative period. The patients experienced minimal postoperative discomfort and returned to baseline activity on the first postoperative day. CONCLUSION: The authors believe that the described technique of biopsy site plugging offers a safe alternative for liver biopsy among patients with an uncorrectable coagulopathy and those requiring a biopsy before correction of the bleeding disorder.

Adolescent↗

PubMed2004

What is the evidence for using hemostatic agents in surgery?

The pharmacological methods used to achieve systemic hemostasis have generated much discussion due to concerns of serious adverse effects (e.g., thromboembolic complications) and costs of therapy in addition to efficacy considerations. There are a limited number of well-controlled trials involving pharmacological hemostasis for spine surgery. In the largest double-blinded randomized controlled trial to date involving spine surgery, there was a trend toward reduced homologous transfusion in patients receiving aprotinin, but the only statistically significant result ( p<0.001) was a reduction in autologous red cell donations. The findings of this trial are important, since the investigators used a number of restrictive transfusion strategies (e.g., autologous donation, low hematocrit trigger for transfusion, blood-salvaging procedures with the exception of no cell saver) that were not always employed in earlier trials involving hemostatic agents. Smaller studies involving antifibrinolytic agents other than aprotinin have demonstrated reductions in blood loss and transfusion requirements in patients undergoing spine surgery, although the results were not always statistically significant. A very large randomized trial would be required to address comparative medication- and transfusion-related adverse events; such a trial involving patients undergoing cardiac surgery is currently being performed. Additionally, cost-effectiveness analyses are needed to help define the role of these agents based on the data that is available.

Aprotinin↗

PubMed2000

[Hemostatic wound management in marcumar patients. Collagen fleece vs. tranexamic acid].

A total of 124 patients on oral anticoagulation therapy with coumarin were treated by orosurgical procedures and entered into a study to determine the hemostatic efficiency of different methods. The therapeutic anticoagulation level was determined in accordance with the recommendations of the American Heart Association (low risk: 2.0 < INR < 3.0; high risk: 2.5 < INR < 3.5) and maintained during treatment. In one group, the alveoli were treated with collagen, in a second group a mouthrinse regime with tranexamic acid was implemented. Twenty-three patients had to be excluded because anticoagulation levels differed from the recommended values. The group treated with collagen included 31 patients, the group with tranexamic acid mouthwashes, 32 patients. A third group was analyzed in which a controlled change in the anticoagulation level had been performed and all treated alveoli had been covered by mucosal flaps (n = 38); they were compared to the other two groups. The surgical proceedings were outlined precisely. Patients treated with collagen had a bleeding rate of 19%, patients with tranexamic acid mouthwash 6%, and those treated with mucosal flaps 40%. The data were not suited for statistical evaluation, they were objected to a descriptive analysis: the confidence intervals were determined by tables for binomial distributions. These did confirm the difference in the frequency of bleeding for the tranexamic acid and mucosal flap groups.

Adult↗

PubMed1993

A new hemostatic puncture closure device for the immediate sealing of arterial puncture sites.

After angiography, 6 to 24 hours of bedrest is indicated to assure that adequate hemostasis of the femoral artery has been achieved. Recently, a new hemostatic puncture closure device (HPCD) has been developed, which consists of a resorbable polymer anchor, a resorbable suture, a small collagen plug and an 8Fr delivery device. The device is delivered into the femoral artery through the introducer sheath, the anchor is secured against the intraluminal artery wall, and the collagen plug is deployed on the arterial wall. The prototype of the HPCD was used in 20 patients administered heparin. After insertion of the HPCD, hemostasis was achieved in 1.2 +/- 2.1 minutes; in 2 patients a light pressure dressing was applied for 4 hours to stop oozing. No late bleeding occurred. In 1 patient the positioning suture broke, requiring the application of a pressure bandage. Patients were uneventfully mobilized after 6.7 +/- 3.5 hours. In all patients serial duplex scanning of the femoral artery was performed before and after 1, 7, 30 and 90 days after HPCD placement. In 5 patients a small subcutaneous hematoma close to the site of introduction could be detected by ultrasound 1 day after catheterization. All but 1 patient had normalization of the flow patterns in the femoral artery. It is concluded that: (1) the HPCD is an effective device to achieve immediate hemostasis after arterial catheterization despite antithrombotic therapy, (2) early mobilization was uneventful, (3) duplex ultrasound studies demonstrated only transient changes in the punctured femoral artery, and (4) further investigations are needed to establish the efficacy and safety of the device.

Equipment Design↗

PubMed1991

Effects of nomegestrol acetate (5 mg/d) on hormonal, metabolic and hemostatic parameters in premenopausal women.

The effects of nomegestrol acetate on circulating hormone levels, metabolic and hemostatic parameters and blood pressure were studied in 36 premenopausal women. The progestogen was administered from day 7 to 25 of the cycle during six cycles at a dosage (5 mg/d) known to inhibit ovulation. Analysis were performed before and in the third and sixth cycles. Estradiol and progesterone levels decreased significantly (p less than 0.001) during treatment. Body weight, fasting blood glucose and insulin, total HDL and LDL cholesterol, apolipoprotein B, fibrinogen and plasminogen did not change significantly. Triglycerides in the third cycle (p less than 0.05) and apolipoprotein A1 levels (p less than 0.01) in both periods of sampling decreased significantly. There was a significant increase in antithrombin III (p less than 0.01). These results indicate that nomegestrol acetate has no deleterious effect on blood glucose and lipids. The decrease in apolipoprotein A1 and increase in antithrombin III may be related either to the decrease in estradiol levels induced by the treatment or to the effect of the progestogen itself.

Adolescent↗

PubMed1978

A study on the use of fluoroalkyl cyanoacrylate adhesive as a hemostatic agent and dressing after exodontia.

A fluoroalkyl cyanoacrylate is shown to be a very effective hemostatic agent in routine extractions in rhesus monkeys. Clinical and histologic observations of the healing sockets at selected intervals revealed uneventful healing, even when the tissue adhesive was placed directly against the alveolar bone within the extraction socket. The quantity, quality, and rate of bone replacement were not different between the experimental and control groups. When polymerized cyanoacrylate is entrapped within the connective tissue above the healing socket, it is effectively removed by normal tissue phagocytes.

Alveolar Process↗

PubMed1991

Textured collagen, a hemostatic agent. A pilot study.

The hemostatic properties of a new form of bovine collagen were observed on 25 dental patients. Early in the investigation it became apparent that pain, swelling, and trismus were reduced and healing was accelerated.

Adolescent↗

PubMed1995

Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device.

OBJECTIVES: This study was performed to test the safety and efficacy of a novel bioabsorbable hemostatic puncture closure device deployed through an arterial sheath. BACKGROUND: Cardiac catheterization procedures are associated with a risk of complications at the arterial access site. Increasing numbers of interventional procedures requiring large sheaths or intense anticoagulation underline the need for secure, rapid methods of obtaining hemostasis at the time of sheath removal. METHODS: We conducted a randomized, multicenter trial in 435 patients undergoing cardiac catheterization or angioplasty at eight participating centers. In 218 patients, hemostasis was achieved using the device (group I); 217 patients were assigned to the manual pressure control group (group II). RESULTS: There were no significant differences in baseline characteristics. Time to hemostasis was considerably shorter in group I (2.5 +/- 15.2 vs. 15.3 +/- 11.7 min [mean +/- SD], p < 0.0001). The deployment success rate for the device was 96%, and 76% of group I patients experienced immediate (within 1 min) hemostasis. Complication rates were lower in group I for bleeding, hematoma and occurrence of any complication. There was no difference in the small incidence of pseudoaneurysm formation. There was no change in either group in the ankle/brachial systolic blood pressure index. Ultrasound follow-up studies 60 days after device deployment revealed complete absorption of the device in all cases. Subgroup analysis revealed particular benefit in patients undergoing interventional procedures. The administration of heparin was associated with a significantly higher complication rate in the manual pressure control group, whereas heparin had no effect on hemostasis time or complication rates in the device group. CONCLUSIONS: This sheath-deployed, bioabsorbable device provides a safe and effective means of obtaining rapid arterial hemostasis after cardiac catheterization procedures. It appears to be particularly useful in those patients most at risk for access site complications.

Aneurysm, False↗

PubMed2005

The use of the levonorgestrel-releasing intrauterine system in the management of menorrhagia in women with hemostatic disorders.

OBJECTIVE: The study was undertaken to evaluate the levonorgestrel-releasing intrauterine system (LNG-IUS) in managing menorrhagia associated with hemostatic disorders. STUDY DESIGN: Retrospective notes review. RESULTS: Nineteen of 28 (68%) patients experienced improvement with the LNG-IUS. There was nonacceptance by 9 of 28 (32%) who refused the LNG-IUS or had it definitively removed. CONCLUSION: The LNG-IUS should be considered when managing menorrhagia because surgery carries additional risks in this subset of patients.

Female↗

PubMed2006

Safety and hemostatic effect of recombinant activated factor VII in cirrhotic patients undergoing partial hepatectomy: a multicenter, randomized, double-blind, placebo-controlled trial.

BACKGROUND: Coagulopathy caused by cirrhosis may contribute to excessive bleeding during hepatectomy. We evaluated the hemostatic effect and safety of recombinant factor VIIa (rFVIIa) in cirrhotic patients undergoing partial hepatectomy. METHODS: Patients were randomized to rFVIIa 50 or 100 mug/kg or placebo, administered intravenously 10 minutes before surgery and every second hour during surgery. The primary efficacy end points were the proportion of patients receiving red blood cell (RBC) transfusions and the amount of RBCs transfused. The RBC transfusion trigger was blood loss of 500 mL. Safety end points included thromboembolic and adverse events. RESULTS: No statistically significant effect of rFVIIa treatment on efficacy end points was observed. Serious and thromboembolic adverse events occurred at similar incidences in the study groups. CONCLUSIONS: Using blood loss as a transfusion trigger, the efficacy of rFVIIa in reducing the requirement for RBC transfusion was not established in this study. No safety concerns were identified.

Adult↗

PubMed2006

Aprotinin shows both hemostatic and antithrombotic effects during off-pump coronary artery bypass grafting.

BACKGROUND: Hemostatic drugs are widely thought to be unnecessary and potentially detrimental in off-pump coronary artery bypass graft surgery (OPCABG), despite well-established use in on-pump surgery. In a randomized, prospective OPCABG trial, we assessed efficacy and safety of aprotinin through a comprehensive assessment of graft patency and hematologic function. METHODS: Sixty patients were randomly assigned to full-dose aprotinin or placebo. Heparin was titrated to a kaolin-based activated clotting time of greater than 300 seconds. Exclusionary criteria included creatinine greater than 2 mg/dL, conversion to on-pump CABG, and preoperative GPIIb/IIIa inhibition. Hematologic assessments were obtained preoperatively, at the end of surgery, and on days 1 and 3: mean platelet volume, thrombin generation (prothrombin fragment 1.2 assay), and aspirin resistance using a modified thrombelastography, whole blood aggregometry, 11-dehydro-thromboxane B2 levels, and flow cytometry. Thrombotic events were defined as postoperative myocardial infarction by electrocardiography or elevated troponin I, clinical stroke by examination and head computed tomography, and bypass graft failure by multichannel computed tomography angiography on day 5. RESULTS: Aprotinin was associated with a significant reduction in intraoperative and postoperative blood loss compared with placebo but had no effect on transfusion rates. Patients treated with aprotinin had significantly fewer thrombotic events (3% versus 23%, p < 0.05, Fisher's exact test) and less postoperative aspirin resistance (20% versus 46%, respectively, p < 0.05, Fisher's exact test). Postoperative prothrombin fragment 1.2 level was reduced by aprotinin use. CONCLUSIONS: Aprotinin reduced perioperative bleeding after OPCABG. Preserved aspirin sensitivity in the aprotinin group may explain the observed reduction in thrombotic events and might be related to the suppression of perioperative and transmyocardial thrombin formation.

Aprotinin↗

PubMedDate not supplied

Early mobilization after diagnostic cardiac catheterization with the use of a hemostatic bandage containing thrombin.

The aim of the present study was to assess the efficacy and safety of a thrombin-containing bandage for local hemostasis after femoral sheath removal in patients undergoing diagnostic cardiac catheterization. Forty-one patients undergoing diagnostic coronary angiography using a 6-F femoral sheath were included. The sheath was removed immediately after the procedure using the bandage according to a prespecified protocol. Mean compression time was 7.3+/-1.7 min and mean time from sheath removal to mobilization was 132+/-34 min. None of the patients suffered recurrent bleeding or any in-hospital and 7-day vascular complications. We conclude that in patients undergoing femoral-access diagnostic cardiac catheterization, the use of a hemostatic bandage containing thrombin was associated with short time to hemostasis with the ability for early patient mobilization without vascular complications.

Bandages↗

PubMed2004

A porcine epistaxis model: hemostatic effects of octylcyanoacrylate.

OBJECTIVE: To develop a standardized porcine epistaxis model and evaluate the hemostatic effects of octyl-cyanoacrylate (OCA). STUDY DESIGN AND SETTING: Twenty-four standardized full-thickness wounds were created on the nasal septae of 7 pigs with a 4-mm surgical punch. Wounds were randomized to no treatment or topical OCA before and after full heparinization. The rate of hemostasis, time to hemostasis, and number of applicators of OCA required to achieve complete hemostasis were determined and groups were compared with t tests and chi2 tests. RESULTS: Complete and sustained hemostasis was achieved in all wounds treated with OCA. The time to hemostasis was significantly shorter in the wounds treated with OCA vs those left to clot on their own (mean difference, 150 seconds; 95% CI, 92 to 209 seconds, P<0.001). None of the wounds required more than 3 applications of OCA. CONCLUSIONS: We describe a simple and reproducible animal epistaxis model and demonstrate that OCA is effective in achieving hemostasis in this model.

Administration, Topical↗

PubMed2001

Infectious complications resulting from use of hemostatic puncture closure devices.

BACKGROUND: Femoral access site complications have increased as the fields of invasive cardiology, radiology, and endovascular surgery have emerged. In order to address one of these complications, hemorrhage, the hemostatic puncture closure devices were developed. METHODS: Retrospective review of cardiac catheterizations performed at a single institution to investigate infectious groin complications related to use of the Perclose Prostar and Techstar devices. RESULTS: Infectious groin complications were significantly higher in the Perclose group as compared with manual compression. Three patients had clinical and laboratory evidence of arterial infection whereas 2 had soft tissue infections. All 5 required operative intervention ranging from incision and drainage to arterial reconstruction. Hemorrhagic complications were not significantly different between the two groups. CONCLUSIONS: The Perclose devices provide hemostasis after femoral artery catheterization similar to manual compression. However, infectious groin complications appear to be more common with these devices.

Cardiac Catheterization↗

PubMed1989

High-dose aprotinin: hemostatic effects in open heart operations.

Two groups of patients were prospectively studied to evaluate the hemostatic effects of high-dose aprotinin in open heart operations. Group A patients (n = 22) received aprotinin during the entire surgical procedure. Group B patients (n = 12) served as controls. The groups were homogeneous for base variables and for cardiopulmonary bypass duration. Postoperative bleeding was lower in group A (mean, 486 mL) than in group B (830 mL) (p less than 0.01). The need for banked blood decreased by approximately half in the aprotinin patients (mean: group A, 213 mL; group B, 409 mL). Hemoglobin levels were similar in the two groups (postoperative day 7: group A, 11.29 g/100 mL; group B, 11.26 g/100 mL; NS). Platelet count decreased at the end of operation in both groups (99,000 and 95,000/mL, respectively; NS) and then increased beyond baseline levels before discharge. No complications were observed that could be attributed to aprotinin. In conclusion, we believe that the use of high-dose aprotinin is safe and effective. It decreases blood loss and reduces the need for banked blood in cardiac operations, particularly in select groups of patients (eg, those undergoing reoperation, Jehovah's Witnesses, those with renal failure).

Adult↗