Study of Recombinant Human Thrombin for Bleeding During Surgery - Full Text View

Purpose

The purpose of this study is to determine whether recombinant human Thrombin (rhThrombin) is effective in stopping bleeding during surgery, in comparison with bovine thrombin.

Condition	Intervention	Phase
Surgical Hemostasis	Biological: rThrombin Drug: bovine thrombin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 3, Randomized, Double-Blind, Controlled, Comparative Efficacy and Safety Study of Topical Recombinant Human Thrombin (rhThrombin) and Thrombin-JMI (Bovine Thrombin) in Surgical Hemostasis

Resource links provided by NLM:

Drug Information available for: Gelatin Thrombin Thrombin alfa

U.S. FDA Resources

Further study details as provided by ZymoGenetics:

Primary Outcome Measures:

Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence and severity of adverse events [ Time Frame: Up to 29 days ] [ Designated as safety issue: Yes ]
Incidence and grade of clinical laboratory abnormalities [ Time Frame: Up to 29 days ] [ Designated as safety issue: Yes ]
Incidence of anti-product antibodies [ Time Frame: Up to 29 days ] [ Designated as safety issue: Yes ]

Enrollment:	401
Study Start Date:	October 2005
Study Completion Date:	July 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 rThrombin	Biological: rThrombin 1000 U/mL applied topically in combination with absorbable gelatin sponge
Active Comparator: 2 bThrombin	Drug: bovine thrombin 1000 U/mL applied topically in combination with absorbable gelatin sponge Other Name: Thrombin-JMI

Detailed Description:

This is a Phase 3 multiple site, randomized, double-blind, controlled trial designed to evaluate the comparative efficacy and safety of rhThrombin and bovine thrombin in patients undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access.

After establishing eligibility, subjects will be randomized in a 1:1 ratio to receive rhThrombin (1000 U/mL) or bovine thrombin (1000 U/mL). During a surgical procedure, study participants will be treated with blinded study drug (rhThrombin or bovine thrombin) in combination with an absorbable gelatin sponge at appropriate bleeding evaluation site(s) and time to hemostasis (TTH) will be assessed for up to 10 minutes. Bleeding appropriate for TTH evaluation is defined as mild to moderate bleeding, either on its own or remaining after brisk bleeding has been controlled by standard surgical modalities. Blinded study drug may also be used at additional appropriate bleeding sites. Study participants will have follow-up visits at about 2 days and 1 month after surgery. Approximately 400 to 600 patients will participate in the study. The final sample size will be determined based on blinded interim results.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access

Exclusion Criteria:

Subject has undergone a therapeutic surgical procedure within 30 days prior to surgery
Subject has history of heparin-induced thrombocytopenia
Subject has known antibodies or hypersensitivity to thrombin or other coagulation factors or known sensitivity to other components of the study treatment
Subject has received blood products within 24 hours prior to surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245336

Show 29 Study Locations

Sponsors and Collaborators

ZymoGenetics

Investigators

Study Director:	Thomas C Reynolds, MD, PhD	ZymoGenetics
Principal Investigator:	William Chapman, MD	Washington University School of Medicine
Principal Investigator:	Kenneth Renkens, MD	Indiana Spine Group
Principal Investigator:	Fred Weaver, MD	University of Southern California

More Information

No publications provided by ZymoGenetics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Weaver FA, Lew W, Granke K, Yonehiro L, Delange B, Alexander WA; Study Investigators. A comparison of recombinant thrombin to bovine thrombin as a hemostatic ancillary in patients undergoing peripheral arterial bypass and arteriovenous graft procedures. J Vasc Surg. 2008 Jun;47(6):1266-73. Epub 2008 Apr 28.

Chapman WC, Singla N, Genyk Y, McNeil JW, Renkens KL Jr, Reynolds TC, Murphy A, Weaver FA. A phase 3, randomized, double-blind comparative study of the efficacy and safety of topical recombinant human thrombin and bovine thrombin in surgical hemostasis. J Am Coll Surg. 2007 Aug;205(2):256-65. Epub 2007 Jun 27.

Responsible Party:	Allan Alexander, MD, ZymoGenetics, Inc.
ClinicalTrials.gov Identifier:	NCT00245336 History of Changes
Other Study ID Numbers:	499E01
Study First Received:	October 25, 2005
Last Updated:	March 6, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by ZymoGenetics:

hemostasis
surgery
hemostatics
randomized controlled trial
phase 3

Additional relevant MeSH terms:

Thrombin
Gelatin Sponge, Absorbable
Hemostatics
Coagulants

Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013