Randomized trial of a dry-powder, fibrin sealant in vascular procedures
Autor: | Ian Chetter, Gregory L. Moneta, Albert Yurvati, NavYash Gupta, Linda A. Zuckerman, John P. Pribble, Surendra Shenoy, Paul D. Hayes |
---|---|
Rok vydání: | 2015 |
Předmět: |
Male
medicine.medical_specialty Time Factors Nausea medicine.medical_treatment Administration Topical Carotid endarterectomy Fibrin Tissue Adhesive Kaplan-Meier Estimate Postoperative Hemorrhage Fibrin Hemostatics law.invention Randomized controlled trial law Risk Factors medicine Humans Single-Blind Method Adverse effect Aged Netherlands biology business.industry Hemostatic Techniques Hazard ratio Anticoagulants Middle Aged Gelatin Sponge Absorbable United Kingdom United States Surgery Treatment Outcome Hemostasis Anesthesia biology.protein Platelet aggregation inhibitor Female medicine.symptom Powders Cardiology and Cardiovascular Medicine business Vascular Surgical Procedures Platelet Aggregation Inhibitors |
Zdroj: | Journal of vascular surgery. 62(5) |
ISSN: | 1097-6809 |
Popis: | Topical hemostats are important adjuncts for stopping surgical bleeding. The safety and efficacy of Fibrocaps, a dry-powder, fibrin sealant containing human plasma-derived thrombin and fibrinogen, was evaluated in patients undergoing vascular surgical procedures.In this single-blind trial (clinicaltrials.gov: NCT01527357), adult patients were randomized 2:1 to Fibrocaps plus gelatin sponge (Fibrocaps) vs gelatin sponge alone. Results are presented for the patient subset undergoing vascular procedures with suture hole bleeding. The primary efficacy endpoint compared time to hemostasis (TTH) over 5 minutes. Safety follow-up continued to day 29.A total of 175 patients were randomized and treated (Fibrocaps, 117; gelatin sponge, 58). Patients were predominately male (69%) and underwent arterial bypass (81%), arteriovenous graft formation (9%), or carotid endarterectomy (9%). Fibrocaps significantly reduced TTH compared with gelatin sponge (hazard ratio [HR], 2.1; 95% confidence interval [CI], 1.5-3.1; median TTH, 2 minutes; 95% CI, 1.5-2.5 vs 4 minutes; 95% CI, 3.0-5.0; P .002). Significant reductions were also observed in patients receiving concomitant antiplatelet agents alone (HR, 2.8; 95% CI, 1.0-7.4; P = .03; n = 33), anticoagulants alone (HR, 2.0; 95% CI, 1.0-4.0; P = .04; n = 43), or both antiplatelet agents and anticoagulants (Fibrocaps vs gelatin sponge, HR, 2.3; 95% CI, 1.2-4.3; P = .008; n = 65). Incidences of common adverse events (procedural pain, nausea, constipation) were generally comparable between treatment arms. Anti-thrombin antibodies developed in 2% of Fibrocaps-treated patients and no-gelatin-sponge patients.Fibrocaps, a ready-to-use, dry-powder fibrin sealant, was well-tolerated and reduced TTH in patients undergoing vascular procedures, including those receiving antiplatelet agents and/or anticoagulants, demonstrating its safety and usefulness as an adjunct to hemostasis. |
Databáze: | OpenAIRE |
Externí odkaz: |