Study of Recombinant Human Thrombin for Bleeding During Surgery
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
1 other identifier
interventional
401
1 country
29
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Oct 2005
Shorter than P25 for phase_3
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 25, 2005
CompletedFirst Posted
Study publicly available on registry
October 27, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedMarch 9, 2009
March 1, 2009
8 months
October 25, 2005
March 6, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes
10 minutes
Secondary Outcomes (3)
Incidence and severity of adverse events
Up to 29 days
Incidence and grade of clinical laboratory abnormalities
Up to 29 days
Incidence of anti-product antibodies
Up to 29 days
Study Arms (2)
1
EXPERIMENTALrThrombin
2
ACTIVE COMPARATORbThrombin
Interventions
1000 U/mL applied topically in combination with absorbable gelatin sponge
Eligibility Criteria
You may qualify if:
- Subject is undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZymoGeneticslead
Study Sites (29)
Cardio Thoracic Surgeons, P.C.
Birmingham, Alabama, 35213, United States
Cardio Thoracic Surgeons, P.C., Medical Center East / Baptist Montclair
Birmingham, Alabama, 35235, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Methodist Hospital
Arcadia, California, 91007, United States
Glendale Adventist Medical Center
Glendale, California, 91206, United States
University of Southern California, Keck School of Medicine
Los Angeles, California, 90033, United States
University of Southern California, Keck School of Medicine
Los Angeles, California, 90333, United States
Huntington Memorial Hospital
Pasadena, California, 91105, United States
Baptist Clinical Research
Pensacola, Florida, 32501, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60611, United States
Northwestern University Vascular Surgery
Chicago, Illinois, 60611, United States
Indiana Spine Group
Indianapolis, Indiana, 46260, United States
Bluegrass Orthopedics/Bluegrass Musculoskeletal Research
Lexington, Kentucky, 40509, United States
Vascular Surgery Associates
Baton Rouge, Louisiana, 70809, United States
Tulane University Abdominal Transplant
New Orleans, Louisiana, 70112, United States
VAMC Clinical Research Center
Detroit, Michigan, 48201, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Mt. Sinai School of Medicine
New York, New York, 10029, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
University of North Texas Science Center at Fort Worth
Fort Worth, Texas, 76107, United States
Clinical Trials of Texas
San Antonio, Texas, 78229, United States
Physician's Research Options, LLC/The Intermountain Spine Institute
Murray, Utah, 84107, United States
University of Utah
Salt Lake City, Utah, 84132, United States
University of Virginia
Charlottesville, Virginia, 22908, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
Related Publications (2)
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. doi: 10.1016/j.jvs.2008.01.034. Epub 2008 Apr 28.
PMID: 18440754DERIVEDChapman 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. doi: 10.1016/j.jamcollsurg.2007.03.020. Epub 2007 Jun 27.
PMID: 17660072DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 25, 2005
First Posted
October 27, 2005
Study Start
October 1, 2005
Primary Completion
June 1, 2006
Study Completion
July 1, 2006
Last Updated
March 9, 2009
Record last verified: 2009-03