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Cardiovascular effects and efficacy of a hemostatic agent in periradicular surgery.

The purpose of this study was to evaluate the hemostatic efficacy and systemic cardiovascular effects of CollaCote collagen sponges saturated with 2.25% racemic epinephrine during endodontic surgery. A total of 48 patients participated in the study. Patients received CollaCote-saline or CollaCote-epinephrine placed in the bony crypt, after which hemostatic efficacy was evaluated. Blood pressure and pulse rate was recorded before and after administration of the local anesthetic, after the application of the test solutions, and before the patient's dismissal. Results showed no significant difference in blood pressure or pulse rate between the experimental and control groups. In the CollaCote-saline group, five of six cases failed to achieve hemorrhage control. In the CollaCote-epinephrine group, 1 of 42 cases had no hemorrhage control. Two patients had slight but apparent intermittent bleeding. Complete hemostasis was achieved in 39 of 42 cases. In conclusion, the results suggest that CollaCote collagen sponges saturated with 2.25% racemic epinephrine provide excellent hemostasis with no evident changes in blood pressure or pulse rate.

Absorbable Implants↗

Prospective, randomized, controlled clinical trial of a novel matrix hemostatic sealant in patients with acute anterior epistaxis.

OBJECTIVES: Floseal, a novel hemostatic sealant composed of collagen-derived particles and topical bovine-derived thrombin, is applied as a high-viscosity gel for hemostasis. This study is a prospective, randomized, controlled clinical trial of Floseal compared with nasal packing in patients with acute anterior epistaxis. STUDY DESIGN: Institutional review board-approved, prospective, randomized, controlled, nonblinded, crossover clinical trial. METHODS: Seventy consecutive patients presenting with acute anterior epistaxis were randomized to receive Floseal or nasal packing for control. Patients were crossed over to the other technique after two unsuccessful attempts of the first technique. Patients were seen in the clinic within 7 days for follow-up. Ten-point visual analogue scales were used to rank effectiveness (1 = ineffective, 10 = effective), physician technical ease (1 = difficult, 10 = easy), physician satisfaction (1 = unsatisfied, 10 = satisfied), patient discomfort during hemostasis (0 = none, 9 = unbearable), patient discomfort at follow-up office visit, and patient satisfaction. Additional data included need for subspecialist consultation to control bleeding, rebleeding rates within 7 days, and rebleeding at follow-up visit. RESULTS: Floseal (n = 35) was judged by physicians to be more effective than nasal packing (n = 35) at initial control of anterior epistaxis (9.9 vs. 7.7, P < .001). Physicians found Floseal to be easier to use (9.4 vs. 3.2, P < .001) and were more satisfied with Floseal (9.6 vs. 3.5, P < .001). Patients experienced less discomfort with Floseal than with nasal packing both at initial control (1.4 vs. 8.9, P < .001) and at follow-up visit (0.0 vs. 8.5, P < .001), and Floseal patients were more satisfied overall (9.1 vs. 2.9, P < .001). Fewer in-person otolaryngology consultations were requested for Floseal patients (8.6% vs. 31.0%, P < .05). Floseal patients experienced fewer rebleeding rates within 7 days (14% vs. 40%, P < .05). Rebleeding rates at follow-up visit were higher in the nasal packing than the Floseal group at time of packing removal (63% vs. 0%, P < .001). Eight (23%) patients were crossed over from the nasal packing group to the Floseal group when nasal packing was ineffective. One Floseal patient (3%, P < .05) was crossed over into the nasal packing group. There were no complications in either group. CONCLUSIONS: Floseal hemostatic sealant is a better tolerated, more effective, safe, and easy alternative to nasal packing in patients presenting with acute anterior epistaxis. Future studies may wish to evaluate Floseal's use in posterior epistaxis.

Acute Disease↗

Modified rapid deployment hemostat bandage terminates bleeding in coagulopathic patients with severe visceral injuries.

BACKGROUND: We recently reported that a new dressing, the Modified Rapid Deployment Hemostat (MRDH) controlled bleeding in hypothermic coagulopathic swine after traumatic liver avulsion. The purpose of this study was to evaluate the MRDH in coagulopathic trauma patients undergoing abbreviated laparotomy. METHODS: A prospective, observational clinical trial of the MRDH dressing was performed at our Level One Trauma Center in patients with high-grade visceral injuries with coagulopathy who failed conventional therapy and required packing. Attending surgeons graded the injury and the adequacy of hemostasis following application of the dressing. Patients were followed until discharge or death. RESULTS: Ten patients were enrolled: nine severe hepatic injuries, and one major abdominal vascular injury. All patients were hypothermic, acidotic, and clinically coagulopathic. Intraoperative hemostasis was immediately obtained after MRDH placement in all cases except one. There was one death. CONCLUSION: The Modified Rapid Deployment Hemostat terminates bleeding from severe visceral injuries in coagulopathic patients undergoing abbreviated laparotomy.

Abdominal Injuries↗

Topical hemostatic agents for dermatologic surgery.

Topical hemostatic agents are very helpful in attaining capillary and small vessel hemostasis in dermatologic surgery. The commonly used topical hemostatic agents, including oxidized cellulose, absorbable gelatin, and thrombin are reviewed, along with newer agents such as microfibrillar collagen, fibrin sealants, and acrylates. Agents best suited for certain situations are recommended.

Administration, Topical↗

Enhancement of experimental anaerobic infections by blood, hemoglobin, and hemostatic agents.

Certain foreign materials have been demonstrated to enhance the infectivity of aerobic and anaerobic bacteria. Whole blood and other protein compounds encountered in surgical settings or trauma were tested for their effect on infectivity of nonsporeforming anaerobic bacteria. Infectious synergistic mixtures of Bacteroides fragilis plus Peptostreptococcus anaerobius and Bacteroides melaninogenicus plus Fusobacterium necrophorum were each diluted to a barely noninfectious or minimally infectious concentration (subinfective inoculum) that was injected intraperitoneally into mice alone and in combination with test proteins. Infectivity was measured by deaths from sepsis or abscess(es) within the abdominal cavity at autopsy at 1 week. Two hemostatic agents, Gelfoam powder and Avitene (final concentrations, 10 mg/ml), and crystalline hemoglobin (4 g/100 ml) each produced a marked increase (P < 0.001) in the rate of infection when mixed with a normally subinfective inoculum of either bacterial mixture. Fresh homologous mouse blood (0.25 ml) injected intraperitoneally without anticoagulant also significantly enhanced infectivity (P < 0.01) of a subinfective inoculum of B. fragilis plus P. anaerobius. These studies demonstrated the capacity of whole blood, hemoglobin, and hemostatic agents to enhance the infectivity of certain nonsporeforming anaerobic bacteria. The high concentrations of anaerobic bacteria in the gastrointestinal, female genital, and respiratory tracts produce an increased risk of human infection after surgery or trauma in these sites; the protein agents studied here may further enhance infection.

Anaerobiosis↗

Ultra-early hemostatic therapy for intracerebral hemorrhage.

BACKGROUND: Intracerebral hemorrhage (ICH) causes higher morbidity and mortality than other forms of stroke and has no proven effective treatment. Hematoma volume is a powerful predictor of outcome after ICH. SUMMARY OF REVIEW: Historically, ICH bleeding was considered to be a monophasic event that stopped quickly as a result of clotting and tamponade by surrounding brain tissue. More recently, prospective and retrospective CT-based studies have demonstrated that hematoma growth occurs in up to 38% of patients initially scanned within 3 hours of onset and in 16% scanned between 3 and 6 hours, even in the absence of coagulopathy. Progressive bleeding of this type has been associated with contrast extravasation on CT angiography and poor outcome after early (<4 hours) surgical clot evacuation. On the basis of these observations, it is plausible that ultra-early hemostatic therapy given in the emergency setting might reduce ICH volume in some patients and improve outcome. Among candidate agents for this indication, the most promising is recombinant activated factor VIIa, which promotes local hemostasis at sites of vascular injury in both coagulopathic and normal patients. CONCLUSIONS: Ultra-early hemostatic therapy, given within 3 to 4 hours of onset, may potentially arrest ongoing bleeding and minimize hematoma growth after ICH. Given the current lack of effective therapy for ICH, clinical trials testing this treatment approach are justified.

Cerebral Angiography↗

Biocompatibility and performance in vitro of a hemostatic gelatin sponge.

The biocompatibility of a hemostatic gelatin sponge (Cutanplast Standard) was evaluated in vitro. Cytotoxicity was assessed by neutral red uptake and amido black staining tests; genotoxicity was assayed using the Ames test, Sister Chromatides Exchanges (SCE) and chromosomal aberrations. The ability of the hemostatic gelatin sponge to induce platelet adhesion and release reaction was also determined. The undiluted extract of the test material was found to be cytotoxic, but cell viability was not affected by 1:2 and 1:10 diluted extract. The same extract was found to be non-genotoxic using the three assays for genotoxicity. A significant decrease of platelet number, as well as a significant release of platelet factor 4 was found to be caused by the solid material. In conclusion, Cutanplast Standard is neither cytotoxic nor genotoxic, while inducing platelet adhesion and release reaction when challenged with blood.

Absorbable Implants↗

Hemostatic Balance Index in TIA patients: sex-related changes.

In order to evaluate the occurrence of hemostatic disorders, 37 patients with transient ischemic attacks (TIAs) and 50 control subjects were studied by means of the Hemostatic Balance Index (H.B.I.) derived from Raby's Thrombodynamic Potential Index (T.P.I.) and Fearnley's Whole Blood Diluted Lysis Time (W.B.D.L.T.). Results showed a significant increase in T.P.I. and a tendency to a decrease in fibrinolytic activity in the TIA group: H.B.I. was shown to be significantly increased, thus indicating a pro-thrombotic imbalance in these patients. The occurrence of similar changes in TIA females when compared to male patients marks the importance of plasmatic factors in the mechanism of thrombotic disorders in females with cerebrovascular disease.

Adult↗

Hemostatic and fibrinolytic status in patients with ovarian cancer and benign ovarian cysts: could D-dimer and antithrombin III levels be included as prognostic markers for survival outcome?

We determined the hemostatic and fibrinolytic status in 60 patients with ovarian cancer and benign ovarian cysts. Hypercoagulation, increased platelets, and enhanced fibrinolysis were seen in patients with preoperative ovarian cancer compared to patients with benign ovarian cysts. Enhanced thrombin generation, evidenced by increased F1+2 and decreased antithrombin III (ATIII) levels with further enhanced fibrinolysis by elevated D-dimer, was seen in advanced cancer. Ten ovarian cancer patients died within 13 months after diagnosis and another died at 24 months, all from advanced stage of cancer, except one from stage IC cancer who died at 11 months. The survival rates from the disease at 13 months and 24 months were 66.7% and 45%, respectively. Most of the patients had gone through the complete course of chemotherapy, and those patients still alive have been disease free between 13 and 42 months. No statistical relationships for the hemostatic parameters studied in ovarian cancer patients could be found between those who died and those still living 13 and 24 months after diagnosis, except for ATIII and D-dimer levels. Elevated D-dimer levels were associated with those who died within 13 and 24 months from the disease, and the decreased ATIII levels only reached statistical significance by 24 months. It could be suggested that these two parameters might be useful as systemic prognostic markers in survival outcome from the disease for the first 24 months in advanced ovarian cancer, in addition to the known correlation with the International Federation of Gynecology and Obstetrics stage.

Adolescent↗

Hemostatic agents: brain tissue reaction and effectiveness. A comparative animal study using collagen fleece and oxidized cellulose.

In a series of 26 young rabbits, three cortical lesions were made in each hemisphere. Two of these holes were filled with collagen fleece (CF) and oxidized cellulose (OC), respectively, while the third was left empty as a control. The bleeding time was measured. Hemostasis with CF was statistically significantly faster than with OC, which in turn was statistically significantly faster than with no hemostatic agent. The animals were killed successively on Days 7, 14, 28, 42, and 241 after operation. Histopathological investigation showed that CF did not induce more tissue reaction that the control lesion and that CF was resorbed faster than OC. The removal of OC occurred from the borders of the material, moving gradually inward. With CF, there was an immediate ingrowth of reactive cells throughout the material. In contrast to OC, CF did not induce the formation of polynucleated giant cells. From these results, it can be concluded that CF is a fast, safe, and absorbable topical hemostatic agent suitable for use in neurosurgical procedures.

Animals↗

Hemostatic action of OC-108, a novel agent for hemorrhoids, is associated with regional blood flow arrest induced by acute inflammation.

Clinically, hemorrhoidal bleeding and prolapse disappeared immediately after injection of the sclerosing agent OC-108 into submucosa of hemorrhoids. The aim of this study was to elucidate the mechanism of action responsible for the immediate hemostatic effect of OC-108 using anesthetized rats. Subcutaneous injection of OC-108 in rats decreased blood flow at the injection site within 5 min. Aluminum potassium sulfate, one of the main ingredients of OC-108, reduced the skin blood flow. However, tannic acid, another main ingredient, did not. By perfusion of OC-108 on the mesenteric surface, microcirculatory blood flow was arrested without remarkable change in blood vessel diameter, accompanied by increased vascular permeability and venous hematocrit. These results indicate that OC-108 induces regional blood flow arrest with rapid onset, this effect being attributed to the action of aluminum potassium sulfate, and that hemoconcentration due to increased vascular permeability (plasma extravasation), an acute inflammatory reaction, is involved in the mechanisms of the immediate hemostatic action of OC-108.

Acute Disease↗

Hemostatic and fibrinolytic activation is less following cutting balloon angioplasty of the coronary arteries.

Recent studies have shown that percutaneous coronary intervention (PCI) activates systemic hemostatic activity, reflecting platelet activation and thrombin formation in the coronary arteries. The present study compared systemic levels of hemostatic markers induced by plain old balloon angioplasty (POBA), coronary stenting (STENT), and cutting balloon (CB) angioplasty. Sixty-one patients with stable angina pectoris, who underwent elective PCI or diagnostic coronary angiography (CAG) alone, were investigated. Patients who underwent PCI were divided into the POBA group (n = 11), the STENT group (n = 27), and the CB group (n = 11). Patients who underwent CAG alone were assigned to the CAG group (n = 12). Blood samples were collected before, 24 hours after, and 3 days after PCI or CAG. Plasma concentrations of prothrombin fragment 1+2 (F1+2), fibrinopeptide A (FPA), thrombin-antithrombin III complex (TAT), and plasminogen activator inhibitor-1 (PAI-1) were measured. In the CB group, the F1+2 (1.23 +/- 0.4 nmol/L) level 3 days after PCI was significantly smaller than that of the POBA group (2.37 +/- 0.5 nmol/L) (P < 0.05). The FPA (1.81 +/- 0.9 ng/mL), TAT (3.36 +/- 1.2 ng/mL) and PAI-1 (23.0 +/- 4.1 ng/mL) levels in the CB group 3 days after PCI were significantly smaller than those of the POBA group (P < 0.05, respectively) and STENT group (P < 0.05, respectively), but similar to the CAG group. Systemic hemostasis is activated to a greater extent after POBA and stenting than it is after CB angioplasty of the coronary arteries. This may contribute to the favorable long-term outcome of CB angioplasty.

Aged↗

An evaluation of the hemostatic effects of hydrophilic, alcohol, and lipophilic extracts of notoginseng.

STUDY OBJECTIVE: To compare the hemostatic effects of hydrophilic, alcohol, or lipophilic extract of notoginseng with those of the control and placebo. DESIGN: Hemorrhagic rat model. SETTING: Hartford Hospital, Hartford, Connecticut; animals were housed at the Hartford Hospital animal facility. ANIMALS: Sixty-two male Wistar rats. Intervention. Administration of placebo (wheat flour), and alcohol, hydrophilic (water), and lipophilic (hexane) extracts of notoginseng. METHODS: Rats were divided into five groups, and their tails were transected 5 mm from the tip. Group 1 received no treatment (control), group 2 received placebo, group 3 received alcohol extract, group 4 received hydrophilic extract, and group 5 received lipophilic extract. Total bleeding time was determined and compared among the groups. MAIN RESULTS: Bleeding time was shorter for the placebo group than the control group (p=0.035). The alcohol extract group had the shortest bleeding time, which was significantly shorter than that of the control (p<0.0001), placebo (p=0.0124), and lipophilic extract groups (p=0.002). The hydrophilic extract group had a shorter bleeding time than the control group (p=0.0058) and showed a trend toward shorter bleeding time than the lipophilic extract group (p=0.068). CONCLUSIONS: The alcohol extract of notoginseng results in the shortest bleeding time and provides better hemostatic effects than no treatment, placebo treatment, and treatment with lipophilic extract.

Animals↗

Tissue solidification in coping with digestive tract bleeding: hemostatic effect of local injection of 99.5% ethanol.

Tatsuka et al. reported a local injection of 95% ethanol as a new endoscopic treatment of gastric protuberant lesions. In this method, the present author discovered that 99.5% ethanol injection has an excellent hemostatic effect. The author injected 99.5% ethanol into the cut-end of the stalk of 7 massively hemorrhaged cases encountered while performing double snare polypectomy. In all cases, the hemorrhage stopped within 5 or 15 min. In 9 patients with hemorrhagic gastric or duodenal ulcer who were judged at emergency endoscopic examination as needing some hemostatic treatment, an injection of 99.5% ethanol into the bleeding site achieved a satisfactory hemostasis in all of them. Ethanol injection into the surrounding tissue close to the bleeding vessels, a few injecting sites selected usually at 1 to 2 mm away from the bleeding vessels, 0.1 to 0.2 ml a time, could instantly suppress even the pulsatile bleeding with no hazards. If this method is used carefully with endoscopic skill, this should become the first choice for the gastro-intestinal hemorrhage except varices.

Adult↗

The use of a new topical hemostatic agent.

MICROFIBRILLARY COLLAGEN hemostat (MCH) is described in clinical use as a topical hemostatic agent for control of bleeding at the donor site of the free gingival graft procedures. On the basis of clinical trials, it is an excellent adjunct to periodontal surgical procedures.

Administration, Topical↗

A comparative evaluation of hemostatic agents in the management of soft tissue graft donor site bleeding.

BACKGROUND: Periodontal plastic surgery has increased the use of palatal wounds for donor tissue, with the most common complication being excessive bleeding from the palate after harvesting tissue. This study was conducted to evaluate the efficacy of 3 methods for achieving hemostasis on the palate after harvesting donor tissue for autogenous soft tissue grafts. METHODS: Thirty sites were evaluated at surgery for hemostasis and followed over 21 days for healing and adverse events. Three treatment groups were randomly selected and patients received either a test product or control comprising: 1) oxidized regenerated cellulose; 2) absorbable gelatin sponge; or 3) sterile gauze with external pressure as the control. All patients received a surgical stent for the palate. RESULTS: The results were analyzed for smokers and non-smokers, and the median time to hemostasis was significantly shorter when a hemostatic agent was applied to the palatal wounds compared to controls in both groups. Pain assessment showed no differences across treatment groups. However, by 21 days, only the oxidized regenerated cellulose group had complete healing based on blinded clinical evaluation with all sites rated as normal to rapid healing, compared to the absorbable gelatin sponge group where 40% of the sites were rated as slow healing. Adverse events, primarily bleeding episodes during the first 7 days after surgery, were found in 40% of the oxidized regenerated cellulose and gauze control groups, while no sites in the absorbable gelatin sponge group had an adverse event. The patients were followed for an average of 10 months and demonstrated a mean shrinkage of their recipient grafts of 24% in total surface area. CONCLUSIONS: This study concluded that the use of hemostatic agents for palatal wounds is confirmed as the treatment of choice when performing free soft tissue grafts.

Adult↗

Evaluation of a microcrystalline bovine collagen hemostatic agent in canine solid viscera injury using abdominal impedance plethysmography.

Bioelectric impedance as a sensitive noninvasive technique for detecting and monitoring changes in compartmental body fluid volume was used to compare the efficacy of two hemostatic agents in controlling postoperative abdominal bleeding following surgically induced solid viscera injury. Gelatin foam-oxidized cellulose sponge and bovine MCHH were both effective topical hemostatic agents. It appears that MCCH has certain advantages over conventional agents.

Abdominal Injuries↗

Effect of absorbable topical hemostatic agents on the relaxation time of blood: an in vitro study with implications for postoperative magnetic resonance imaging.

OBJECT: Absorbable topical hemostatic agents are commonly used in neurosurgery. In this study the authors examine the longitudinal relaxation time (T1) of blood in contact with these agents over time, measured in vitro, to determine if their presence could affect the interpretation of postoperative magnetic resonance (MR) images. METHODS: Coagulated and anticoagulated blood were used, both oxygenated and deoxygenated. The effects of a collagen-based agent (Collastat) and a cellulose-based agent (Surgicel) on the pH and T1 values of blood and on those of saline (used as a control) were investigated. The T1 was measured as a function of magnetic field strength and time by using a field-cycling relaxometer. This instrument measures 1/T1, the rate of T1, from which the T, value is computed. The T1 values of blood were compared with those of hemostat-induced blood clots and with those of both gray and white matter of the brain. Signal changes on T1-weighted MR images were predicted on the basis of altered T, values in vitro. Postoperative images were visually examined for the predicted changes. With the addition of Surgicel, blood had decreased pH and significantly shortened T1 at all fields, essentially within minutes, although it affected the T1 of saline only minimally. The effect of Surgicel increasingly shortened the T1 for 4 days in oxygenated blood. Collastat had no significant effect. The presence of some paramagnetic methemoglobin in Surgicel-induced clots was demonstrated using the relaxometer at a time when diamagnetic oxyhemoglobin would be present in naturally occurring blood clots. A bright signal that could mimic residual tumor on contrast-enhanced images was predicted and confirmed on postoperative T1-weighted MR images obtained in patients in whom Surgicel lined the tumor bed. It was not present in cases in which Surgicel was not used. CONCLUSIONS: Surgicel alters the appearance of early postoperative MR images. To avoid misinterpretation, clinicians should be aware of this phenomenon.

Absorption↗