A Study of Fibrocaps™ in Surgical Bleeding

Summary

The purpose of this study is to confirm the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis. The investigational products were used in participants with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery, when control of mild to moderate bleeding by standard surgical techniques is ineffective and/or impractical.

Timeline

Start

2012-05-21

Primary completion

2013-04-24

Completion

2013-06-01

Outcome

Met primary endpoint

registry analysis (superiority test); Fibrocaps + Gelatin Sponge vs Gelatin Sponge; p < 0.0001; Log Rank NCT01527357 ↗

paper Fibrocaps significantly reduced TTH compared with gelatin sponge; estimated hazard ratios were 3.3, 2.1, 2.3, and 3.4 PMID 25458801 ↗

Publications

• Gupta N, Chetter I, Hayes P, O-Yurvati AH, Moneta GL, Shenoy S, Pribble JP, Zuckerman LA. Randomized trial of a dry-powder, fibrin sealant in vascular procedures. J Vasc Surg. 2015 Nov;62(5):1288-95. doi: 10.1016/j.jvs.2015.05.038. Epub 2015 Aug 5.
• Bochicchio GV, Gupta N, Porte RJ, Renkens KL, Pattyn P, Topal B, Troisi RI, Muir W, Chetter I, Gillen DL, Zuckerman LA, Frohna PA. The FINISH-3 trial: a phase 3, international, randomized, single-blind, controlled trial of topical fibrocaps in intraoperative surgical hemostasis. J Am Coll Surg. 2015 Jan;220(1):70-81. doi: 10.1016/j.jamcollsurg.2014.09.019. Epub 2014 Oct 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fibrocaps	Protein / enzyme biologic	—	Topical
Subject	Gelatin sponge	Unknown	—	Topical

Indications

No indication recorded.