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PubMed2001

The role of fibrin sealants in hemostasis.

Hemostasis is a prerequisite for wound healing, and under normal physiologic conditions, it is achieved by means of the coagulation cascade. However, there are a number of surgical procedures where there may be considerable benefits to the patient, surgeon, or health-care costs if hemostasis can be achieved more efficiently. The rapid and effective control of bleeding during and after surgery reduces blood loss and can help reduce postoperative complications. These improved outcomes can reduce the need for transfusion, with the associated risk of viral transmission, and have a positive impact on operative and hospital stay times. Fibrin sealants are surgical hemostatic agents derived from human plasma that reproduce the final steps in the coagulation pathway and form a stable fibrin clot. Fibrin sealants are used in a broad range of surgical procedures to assist hemostasis, including cardiovascular, hepatic, and splenic surgery, gastrointestinal hemorrhage, skin grafting, and dental extractions in anticoagulated patients. Patients with coagulopathies are at high risk of prolonged or excessive bleeding during or after invasive surgery, and these patients may also benefit from the use of fibrin sealants. This article reviews the role of fibrin sealants in hemostasis, citing a number of key clinical studies that report a significant reduction in blood loss or chest drain output after surgery with fibrin sealant compared with controls.

Fibrin Tissue Adhesive↗
PubMed2003

[Complications with femoral access in cardiac cathetization. Impact of previous systematic femoral angiography and hemostasis with VasoSeal-ES collagen plug].

INTRODUCTION AND OBJECTIVES: Most cardiac catheterizations are performed via femoral artery access, and hemostatic devices are commonly used. We evaluate the relationship between the strategy used for femoral arteriography and the use of VasoSeal-ES, and local vascular complications. PATIENTS AND METHOD: Prospective study of 540 consecutive catheterizations with systematic femoral artery and sheath angiography. VasoSeal-ES was used in 427 patients. Predictors of local vascular complications such as patient-related factors, anatomy and hemostasis were analyzed. Variables related to failure of the collagen plug were also studied. RESULTS: Punctures of the common femoral artery occurred in 35.9% of all patients (16% in the deep femoral artery and its ostium). Spasm was evident in 18% (ranging from 58.1% in the deep femoral artery to 5.2% in the common femoral artery). Puncture at the site of ramification was seen in 11.3%. Angiographically significant atheroma was seen in 17.8%. The femoral head was a valid landmark for the common femoral artery in only 63.9% of the pateints. Risk factors for local vascular complications were punctures of the common femoral artery, female sex and failure of VasoSeal-ES to achieve hemostasis (15.8% in the first two months of use, 5.2% in the last months of the study). Complications involving superficial and deep femoral arteries occurred in 6.7% and 1.2% of the patients, respectively, in contrast to 0.6% involving the common femoral artery. Variables related to collagen plug failure were patient-related factors, weight less than 55 kg, operator-related factors and the learning curve. CONCLUSIONS: Systematic femoral angiography provides data that aids the choice of the best hemostasis procedure to reduce local vascular complications. Punctures of the common femoral artery were more frequent than expected, and were associated with a higher complication rate. VasoSeal-ES is a safe and useful method of hemostasis, and its infrequent failures were associated with high complication rates that were substantially reduced with experience.

Aged↗
PubMed1999

[Exploration of hemostasis disorders in children (excluding the neonatal period)].

There are three different aspects in the etiological diagnosis of hemostasis disorders: (1) primary hemostasis evaluation; (2) coagulation evaluation; and, (3) thrombosis evaluation. In every case, a look at the medical history is an essential step before proceeding to biological investigations. Bleeding time is the first step of the primary hemostasis evaluation; prolonged drug use (particularly salicylates) and thrombocytopenia must be first considered; only then will the Von Willebrand factor and platelet functions be studied. Coagulation evaluation first requires the study of the overall coagulation tests (Quicks test, partial thromboplastin time test and thrombin time test); determination of the different plasma coagulation factors and search for a circulating anticoagulant will be performed secondarily, allowing differentiation between the different acquired or constitutional coagulation disorders. Thrombosis evaluation must first consider a local or general inciting factor before looking for anti-phospholipid antibodies, an acquired protein C or S deficiency or a constitutional hemostasis disorder.

Adolescent↗
PubMedDate not supplied

Evaluation of a hemostasis model for teaching basic surgical skills.

The need for alternative methods of teaching veterinary medicine and surgery has increased in recent years because of increasing costs and changing public opinion. For these reasons a hemostasis model was developed that mimics the arteries and veins of the peripheral vascular system, and can be used to teach the basic skills involved in blood vessel ligation and division. This study evaluated the effectiveness of the fluid hemostasis model compared with using live animals for teaching these skills. Forty sophomore veterinary students participated in the study. Two groups of 20 students each received identical instruction in the basic techniques required for vessel ligation and division. The students then completed various exercises using inanimate models to objectively evaluate their psychomotor skills. Both groups then practiced the techniques for equal time periods; one group used the hemostasis model and the other performed a splenectomy on live dogs. After the practice session, the students were videotaped (for later evaluation), as they performed vessel ligations and divisions. The students then repeated the exercises using the inanimate models for evaluation of skills improvement. Questionnaire responses before and after the project were obtained to determine the students' views on the need for inanimate models for teaching purposes. Results of this study indicate that the hemostasis model was as effective as live animals for teaching the basic skills involved in blood vessel ligation. The students' opinions regarding the use of properly designed inanimate models for teaching these skills were dramatically changed.

Adult↗
PubMed2003

Minimizing recurrent peptic ulcer hemorrhage after endoscopic hemostasis: the cost-effectiveness of competing strategies.

OBJECTIVES: Controversy exists regarding the optimal strategy to minimize recurrent ulcer hemorrhage after successful endoscopic hemostasis. Our objective was to evaluate the cost-effectiveness of competing strategies for the posthemostasis management of patients with high risk ulcer stigmata. METHODS: Through decision analysis, we calculated the cost-effectiveness of four strategies: 1) follow patients clinically after hemostasis and repeat endoscopy only in patients with evidence of rebleeding (usual care); 2) administer intravenous proton pump inhibitors (i.v. PPIs) after hemostasis and repeat endoscopy only in patients with clinical signs of rebleeding; 3) perform second look endoscopy at 24 h in all patients with successful endoscopic hemostasis; and 4) perform selective second look endoscopy at 24 h only in patients at high risk for rebleeding as identified by the prospectively validated Baylor Bleeding Score. Probability estimates were derived from a systematic review of the medical literature. Cost estimates were based on Medicare reimbursement. Effectiveness was defined as the proportion of patients with rebleeding, surgery, or death prevented. RESULTS: The selective second look endoscopy strategy was the most effective and least expensive of the four competing strategies, and therefore dominated the analysis. The i.v. PPI strategy required 50% fewer endoscopies than the competing strategies, and became the dominant strategy when the rebleed rate with i.v. PPIs fell below 9% and when the cost of i.v. PPIs fell below 10 dollars/day. CONCLUSIONS: Compared with the usual practice of "watchful waiting," performing selective second look endoscopy in high risk patients may prevent more cases of rebleeding, surgery, or death at a lower overall cost. However, i.v. PPIs are likely to reduce the need for second look endoscopy and may be preferred overall if the rebleed rate and cost of i.v. PPIs remains low.

Adult↗
PubMed2006

Genetic background determines response to hemostasis and thrombosis.

BACKGROUND: Thrombosis is the fatal and disabling consequence of cardiovascular diseases, the leading cause of mortality and morbidity in Western countries. Two inbred mouse strains, C57BL/6J and A/J, have marked differences in susceptibility to obesity, atherosclerosis, and vessel remodeling. However, it is unclear how these diverse genetic backgrounds influence pathways known to regulate thrombosis and hemostasis. The objective of this study was to evaluate thrombosis and hemostasis in these two inbred strains and determine the phenotypic response of A/J chromosomes in the C57BL/6J background. METHODS: A/J and C57Bl/6J mice were evaluated for differences in thrombosis and hemostasis. A thrombus was induced in the carotid artery by application of the exposed carotid to ferric chloride and blood flow measured until the vessel occluded. Bleeding and rebleeding times, as surrogate markers for thrombosis and hemostasis, were determined after clipping the tail and placing in warm saline. Twenty-one chromosome substitution strains, A/J chromosomes in a C57BL/6J background, were screened for response to the tail bleeding assay. RESULTS: Thrombus occlusion time was markedly decreased in the A/J mice compared to C57BL/6J mice. Tail bleeding time was similar in the two strains, but rebleeding time was markedly increased in the A/J mice compared to C57BL/6J mice. Coagulation times and tail morphology were similar, but tail collagen content was higher in A/J than C57BL/6J mice. Three chromosome substitution strains, B6-Chr5A/J, B6-Chr11A/J, and B6-Chr17A/J, were identified with increased rebleeding time, a phenotype similar to A/J mice. Mice heterosomic for chromosomes 5 or 17 had rebleeding times similar to C57BL/6J mice, but when these two chromosome substitution strains, B6-Chr5A/J and B6-Chr17A/J, were crossed, the A/J phenotype was restored in these doubly heterosomic progeny. CONCLUSION: These results indicate that susceptibility to arterial thrombosis and haemostasis is remarkably different in C57BL/and A/J mice. Three A/J chromosome substitution strains were identified that expressed a phenotype similar to A/J for rebleeding, the C57Bl/6J background could modify the A/J phenotype, and the combination of two A/J QTL could restore the phenotype. The diverse genetic backgrounds and differences in response to vascular injury induced thrombosis and the tail bleeding assay, suggest the potential for identifying novel genetic determinants of thrombotic risk.

Journal Article↗
PubMed1998

Percutaneous Application of Fibrin Sealant to Achieve Hemostasis Following Arterial Catheterization.

OBJECTIVES: The present study sought to investigate the safety and efficacy of a new fibrin sealant using percutaneous delivery techniques. BACKGROUND: The femoral approach has become the preferred means of access for percutaneous diagnostic and interventional procedures. Control of access site bleeding following catheterization, however, remains a significant problem in interventional cardiology. METHODS: Adult mongrel dogs were used in this study. Series 1 compared the effectiveness of fibrin sealant vs. manual compression alone in the presence of anticoagulants, thrombolytic, and antiplatelet agents. Series 2 assessed fibrin sealant safety. Series 3 examined fibrin sealant performance under elevated blood pressure levels. RESULTS: Series 1: Hemostasis was achieved in all fibrin sealant sites in significantly less time (8.5 +/- 4.3 min) with no major complications compared to manual compression sites (65.2 +/- 19.3 min) accompanied by serious complications. For all adjunctive agents employed, hemostasis was achieved in fibrin sealant sites in significantly less time (warfarin 9.9 +/-.2, urokinase 11.2 +/- 5.6, ReoProª 10.5 +/- 6.3 min) than for manual compression sites (warfarin 86.5 +/- 21.4, urokinase 89.8 +/- 36.3, ReoPro 77.9 +/- 26.5 min). Series 2: I25 iodine-labeled fibrinogen sealant was applied to puncture sites with no traces of circulating radioactivity observed over a one-hour period. Series 3: hemostasis was achieved under elevated blood pressure conditions in all animals. Histologic studies showed complete re-absorption of fibrin sealant 28 days post-procedure with no evidence of foreign body reaction. CONCLUSIONS: Percutaneous application of fibrin sealant to achieve hemostasis following catheterization appears to be a simple, safe, and highly effective procedure in a canine model.

Journal Article↗
PubMed1992

Effect of thrombin-induced hemostasis on the efficacy of an absorbable adhesion barrier.

Serosal injury, bleeding and fibrin deposition are major factors in the development of surgical adhesions; meticulous hemostasis is desirable but not always achievable. The effects of thrombin on adhesion formation and the performance of Interceed Barrier were tested in separate series using a standard model and two levels of bleeding: an "oozing" model in which rabbit uterine horns were scraped to produce uncontrolled punctate bleeding and a "bleeding" model, in which four small blood vessels nicked on the ligament to each horn produced heavier bleeding. Substantial clots in the bleeding model were not removed. Adhesions, assessed after two weeks, were not worsened by the use of thrombin to control bleeding. While Interceed Barrier alone did not reduce adhesions at sites of bleeding, achieving hemostasis with thrombin and then applying Interceed Barrier significantly reduced adhesions. The effect was not achieved by applying thrombin to previously blood-soaked Interceed Barrier. The efficacy of Interceed Barrier applied after achieving hemostasis was further improved by moistening it with heparin. Achieving hemostasis at a bleeding site with thrombin facilitates the efficacy of Interceed Barrier.

Animals↗
PubMed2005

Risk of local adverse events following cardiac catheterization by hemostasis device use - phase II.

OBJECTIVES: To assess the relative risks of serious local adverse events following cardiac catheterization by type of hemostasis device (versus manual compression controls) and gender. BACKGROUND: Reports to the FDA (U.S. Food and Drug Administration) of local vascular complications associated with the use of hemostasis devices following cardiac catheterization and resulting in serious injuries, raised concerns about the safety of these devices. Review of the medical literature also posed cause for concern. METHODS: Data were obtained from the American College of Cardiology-National Cardiovascular Data Registry, modified to suit the needs of this research. It included information from 59 institutions and 13,878 cardiac catheterizations performed during the last quarter of 2003. Multiple logistic regression, using 10 different outcomes, was used to assess the risk associated with type of device and gender, while controlling for demographic and physiologic variables, type of procedure, and several indices of comorbidity. RESULTS: Serious adverse events were reported in 3.37% of patients, the most common being bleeding with hematoma (2.00%). The adjusted odds ratio for women (compared to men) was 1.73 for any vascular complication. Only one hemostasis device, VasoSeal, demonstrated a high risk of any vascular complication compared to manual compression controls (OR = 2.38 [1.47-3.85; p = 0.0004]). This risk was mainly associated with diagnostic cardiac catheterization (OR = 3.36). CONCLUSIONS: VasoSeal appears to pose a greater risk for serious local vascular complications following cardiac catheterization than either manual compression controls or other hemostasis devices. Women have almost twice the risk of men for most local complications.

Cardiac Catheterization↗
PubMed1991

[Postmanipulation hemostasis in angiography from different approaches].

The paper is concerned with some data on the quality of hemostasis after various types of angiography in 629 patients: manual hemostasis in transfemoral catheterization was used in 130 patients, mechanical fixing rubber pellets were used in 108 patients. Postmanipulation tamponade in the area of catheterization was used in 163 of 321 patients after catheterization translumbar angiography. In mechanical hemostasis, hematomas were found in 1.8%, in manual hemostasis--in 4.6%; CT and USI findings showed no hematomas after catheterizations translumbar angiography, in PTLA hematomas over 200 ml were found in 3.7%.

Angiography↗
PubMed1991

[Various mechanisms of disorders of the regulation of hemostasis in acute hemorrhage].

A review has been presented of the author's own investigations and the literature data on the mechanisms of hemocoagulation disorders in acute hemorrhage. The main attention is paid to the state of the vascular-thrombocytic component of the hemostasis system. In acute hemorrhage, like in the normal state, the blood hemostatic potential is characterized by the combination of parameters of the labile and stable components of the hemostasis system. Under conditions of acute hemorrhage the shifts in the blood coagulation system are directed towards hypercoagulation, and the syndrome of disseminated intravascular blood coagulation may develop. Parameters of the vascular-thrombocytic component of the hemostasis play the main role in the triggering of blood coagulation mechanisms. Accelerated movement of fluid from tissues to the blood flow, disorders in microcirculation and blood rheology, monocytic phagocytes system blocking, toxigenic and hemolytic properties of the plasma play a role in the activation of the vascular-thrombocytic hemostasis.

Acute Disease↗
PubMed1990

[The role of thrombocytic-vascular and coagulative hemostasis in the pathogenesis of the Raynaud's phenomenon].

Changes of aggregation properties of thrombocytes may be of significance for the development of disturbances of rheological properties of blood in Raynaud's phenomenon. The disturbances of hemostasis in Raynaud's phenomenon are associated first of all with activation of thrombocytic-vascular hemostasis. Coagulative hemostasis had considerably less alterations. Changes of aggregative properties of thrombocytes and coagulation hemostasis had certain peculiarities in each variation of the Raynaud's phenomenon according to the classification made at the authors' clinic, which supports the validity of this classification.

Adult↗
PubMed1994

Use of a mechanical pressure device for hemostasis following cardiac catheterization.

BACKGROUND: Peripheral vascular complications that can occur after cardiac catheterization are costly and cause patient discomfort. OBJECTIVES: To determine the difference in frequency of vascular complications in a convenience sample of cardiac catheterization patients who had mechanical pressure vs digital pressure for postprocedural hemostasis. METHODS: A quasi-experimental design was used. The study group consisted of 100 patients on whom a mechanical clamp was used to effect hemostasis; the control group consisted of 100 patients who received digital pressure for hemostasis. Data from the control group were obtained retrospectively through review of cardiac catheterization charts. RESULTS: The two groups showed statistically significant differences for the number of catheters used, mean time elapsed between arterial entry and catheter removal, and compression time. There was no significant difference in complication rate between the groups. DISCUSSION: Complications including hematoma formation, arterial occlusion, ischemia and traumatic neuropathy were monitored. CONCLUSIONS: The mechanical pressure device is a safe, cost-effective alternative to digital pressure for hemostasis following cardiac catheterization. Further studies are needed to verify these results and the effectiveness of the device following other percutaneous intra-arterial procedures.

Cardiac Catheterization↗
PubMedDate not supplied

[Changes in certain indicators of hemostasis in rabbits upon administration of Ebola virus preparations].

Changes in some parameters of hemostasis in rabbits insusceptible to Ebola virus (EV) in various periods after reinoculations with live and inactivated virus are described. Challenge with both control protein and live and inactivated EV leads to imbalance in the hemostasis system, which is compensated for in the course of follow-up and does not result in clinically manifest disorders of blood clotting. However, the mechanisms of development of the hemostasis imbalance caused by the control protein and virus preparations were different. In the former case no fibrinogen degradation products were detected in the blood serum, whereas in the latter they appeared in the serum after each reinoculation of the virus. This indicates a peculiar effect of EV on hemostasis.

Animals↗
PubMed1994

Aprotinin preserves hemostasis in aspirin-treated patients undergoing cardiopulmonary bypass.

Various clinical trials have shown that hemostasis is improved by the administration of aprotinin during cardiopulmonary bypass. However, this effect has not been proved for those patients treated preoperatively with aspirin. Therefore, a double-blind, placebo-controlled study was conducted to test the efficacy of low-dose aprotinin (2 x 10(6) KIU in the pump prime solution) in preserving hemostasis in 40 aspirin-treated (325 mg) patients undergoing coronary artery bypass grafting. Aprotinin brought about a decrease in the postoperative blood loss (p < 0.05). The in vitro bleeding test (Thrombostat) demonstrated that aprotinin preserved the platelet hemostatic function in aspirin-treated patients during cardiopulmonary bypass (p < 0.05). The inhibitory effects of aspirin on collagen-induced platelet aggregation and thromboxane production were not influenced by aprotinin treatment. The findings from the present study indicate that aprotinin preserves hemostasis in aspirin-treated patients during cardiopulmonary bypass, but aspirin's effect on platelets is maintained. Therefore, aprotinin seems to be a useful adjunct treatment in aspirin-treated patients undergoing coronary artery bypass grafting.

Aprotinin↗
PubMed2002

Evaluation of a novel hemostatic device in an ovine parenchymal organ bleeding model of normal and impaired hemostasis.

Bleeding is a problem encountered by many surgeons, often complicated by the presence of coagulopathy or anticoagulant. The hemostatic effectiveness of CoStasis Surgical Hemostat (with bovine collagen, bovine thrombin, and autologous plasma) was evaluated and compared to a collagen sponge and to two investigational fibrin-sealant preparations under conditions of normal and impaired coagulation. A liver resection and controlled incisions in spleens and kidneys were made in sheep. Time to complete hemostasis and total blood loss were measured. Tissue response was evaluated at 7, 30, 60, and 75 days. CoStasis-treated sites demonstrated significantly shorter time to hemostasis (all surgical sites combined) compared with fibrin sealant (investigational fibrin sealant 1) (p= .005) or collagen sponge (p=0.013). In anticoagulated animals, CoStasis and fibrin sealant (investigational fibrin sealant 2) had comparable mean times to hemostasis, and CoStasis-treated sites exhibited lowered average blood loss compared to investigational fibrin-sealant-2 treated sites. CoStasis-treated sites demonstrated higher levels of tissue repair (lower inflammation, more extensive tissue repair, and less residual implant) compared to fibrin-sealant- or collagen-sponge-treated sites in Phases I and II. These findings demonstrate that CoStasis is a highly effective hemostatic agent for control of bleeding from parenchymal organs. Furthermore, under conditions of compromised coagulation, treatment with CoStasis demonstrates a reduction in average blood loss when compared to treatment with fibrin sealant.

Animals↗
PubMed1993

Extracorporeal circuit heparinization in selective low density lipoprotein apheresis: changes in patient hemostasis and low molecular weight heparin benefit.

Treatment by low density lipoprotein (LDL) apheresis using dextran sulfate columns (DSC) leads to hemostasis alterations with prolonged activated partial thromboplastin time (APTT) of more than 120 seconds. In order to explain this hypocoagulability, we studied hemostasis parameters both in patients and in the extracorporeal circulation (ECC). Hemostasis changes are first related to unfractionated heparin (UFH)--needed to avoid circuit coagulation--which leads to high residual heparinemia in the patient (more than 3 times the recommended level for therapeutic use). Second, the hypocoagulability is induced by a coagulation factor decrease (primarily factors V, VIII, and X) mainly due to an adsorption mechanism on dextran sulfate. Studies on samples from column inflow, outflow, and eluate confirm this mechanism. Low molecular weight heparin (LMWH) can be used in LDL apheresis on DSC without major changes in lipid removal or coagulation factors compared to UFH. The benefit of using LMWH is to reduce residual heparinemia into the therapeutic range.

Adult↗
PubMed1995

Changes in surgical strategies for peptic ulcers before and after the introduction of H2-receptor antagonists and endoscopic hemostasis.

A total of 902 surgical patients with peptic ulcer disease were evaluated to clarify the effects of H2-receptor antagonists and endoscopic hemostasis on surgical treatment. Following the introduction of these treatments to our institute in 1982, the number of operations performed annually decreased by 40%, or 36 cases per year. However, a remarkable increase in the frequency of surgical emergency intervention since 1982 was concurrently observed, with the ratio of emergency procedures to the total number of operated cases increasing to 72.5% in the last 5 years of the study. Moreover, intractability as an indication for surgery decreased to 34.1%, compared with an increase in the number of patients with bleeding and perforated ulcers requiring operation. There were 13 postoperative deaths recorded (1.4%). All of the deaths were in patients who had undergone emergency surgery in poor health. Of these 13 patients, 10 had bleeding ulcers. A study of bleeding ulcers for which endoscopic hemostasis had been unsuccessful revealed that shock on admission and a concomitant medical condition had been evident in all the patients who died, and in 52.2% and 30.4% of the survivors, respectively. The current study suggests that the frequency of high-risk patients requiring surgery is increasing since the introduction of H2-receptor antagonists and endoscopic hemostasis, and thus, prompt surgical treatment and intensive management for such patients is essential.

Emergencies↗