A Study to Compare Human Thrombin Against Bovine Thrombin in Its Ability to Stop Bleeding After Surgery

NCT00196534 ↗

Phase 3 Completed 304 enrolled Ethicon, Inc. OMRIX Biopharmaceuticals · collab

RandomizedParallel-groupDouble-blind

Summary

The purpose of this study is to see if Human Thrombin is as effective as Bovine Thrombin in stopping surgical bleeding within 10 minutes of application.

Timeline

Start: 2004-11
Primary completion: —
Completion: 2006-07

Outcome

Met primary endpoint

paper The proportion of patients achieving hemostasis within 10 min (primary outcome) was equivalent for human and bovine thrombin (97.4 vs. 97.4%, respectively; ratio, 1.00; 95% CI, 0.96-1.05). PMID 18241525 ↗

Publications

Doria C, Fischer CP, Wood CG, Li PM, Marra S, Hart J. Phase 3, randomized, double-blind study of plasma-derived human thrombin versus bovine thrombin in achieving hemostasis in patients undergoing surgery. Curr Med Res Opin. 2008 Mar;24(3):785-94. doi: 10.1185/030079908X273426. Epub 2008 Jan 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bovine Thrombin	Protein / enzyme biologic	—	Topical
Subject	Human Thrombin	Protein / enzyme biologic	—	Topical

Indications

No indication recorded.