Randomized trial of a dry-powder, fibrin sealant in vascular procedures Abstract based on results presented at Society of Academic and Research Surgery meeting, Durham University, Durham, UK, January 7-8, 2015.

Nav Yash Gupta, Ian Chetter, Paul Hayes, Albert Yurvati, Gregory L. Moneta, Surendra Shenoy, John P. Pribble, Linda A. Zuckerman

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Objective 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. Methods 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. Results 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. Conclusions 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.

Original languageEnglish
Pages (from-to)1288-1295
Number of pages8
JournalJournal of Vascular Surgery
Volume62
Issue number5
DOIs
StatePublished - 1 Nov 2015

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Fibrin Tissue Adhesive
Powders
Blood Vessels
Porifera
Gelatin
Hemostasis
Confidence Intervals
Platelet Aggregation Inhibitors
Anticoagulants
Safety
Thrombin
Vascular Surgical Procedures
Hemorrhage
Single-Blind Method
Carotid Endarterectomy
Constipation
Fibrinogen
Nausea
Sutures
Anti-Idiotypic Antibodies

Cite this

Gupta, Nav Yash ; Chetter, Ian ; Hayes, Paul ; Yurvati, Albert ; Moneta, Gregory L. ; Shenoy, Surendra ; Pribble, John P. ; Zuckerman, Linda A. / Randomized trial of a dry-powder, fibrin sealant in vascular procedures Abstract based on results presented at Society of Academic and Research Surgery meeting, Durham University, Durham, UK, January 7-8, 2015. In: Journal of Vascular Surgery. 2015 ; Vol. 62, No. 5. pp. 1288-1295.
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title = "Randomized trial of a dry-powder, fibrin sealant in vascular procedures Abstract based on results presented at Society of Academic and Research Surgery meeting, Durham University, Durham, UK, January 7-8, 2015.",
abstract = "Objective 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. Methods 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. Results 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. Conclusions 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.",
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Randomized trial of a dry-powder, fibrin sealant in vascular procedures Abstract based on results presented at Society of Academic and Research Surgery meeting, Durham University, Durham, UK, January 7-8, 2015. / Gupta, Nav Yash; Chetter, Ian; Hayes, Paul; Yurvati, Albert; Moneta, Gregory L.; Shenoy, Surendra; Pribble, John P.; Zuckerman, Linda A.

In: Journal of Vascular Surgery, Vol. 62, No. 5, 01.11.2015, p. 1288-1295.

Research output: Contribution to journalArticle

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T1 - Randomized trial of a dry-powder, fibrin sealant in vascular procedures Abstract based on results presented at Society of Academic and Research Surgery meeting, Durham University, Durham, UK, January 7-8, 2015.

AU - Gupta, Nav Yash

AU - Chetter, Ian

AU - Hayes, Paul

AU - Yurvati, Albert

AU - Moneta, Gregory L.

AU - Shenoy, Surendra

AU - Pribble, John P.

AU - Zuckerman, Linda A.

PY - 2015/11/1

Y1 - 2015/11/1

N2 - Objective 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. Methods 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. Results 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. Conclusions 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.

AB - Objective 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. Methods 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. Results 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. Conclusions 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.

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