drugset / Trial / NCT00491608
Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.
Timeline
- Start
- 2007-06
- Primary completion
- 2008-07
- Completion
- 2008-07
Publications
- Randleman CD Jr, Singla NK, Renkens KL, Souza S, Pribble JP, Alexander WA. Persistence of antibodies to the topical hemostat bovine thrombin. J Am Coll Surg. 2010 Dec;211(6):798-803. doi: 10.1016/j.jamcollsurg.2010.07.023. Epub 2010 Oct 25.
- Singla NK, Ballard JL, Moneta G, Randleman CD Jr, Renkens KL, Alexander WA. A phase 3b, open-label, single-group immunogenicity and safety study of topical recombinant thrombin in surgical hemostasis. J Am Coll Surg. 2009 Jul;209(1):68-74. doi: 10.1016/j.jamcollsurg.2009.03.016. Epub 2009 May 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | rThrombin | Protein / enzyme biologic | 1000 unknown | Topical |
Indications
No indication recorded.