Study of Recombinant Human Thrombin for Bleeding During Surgery
NCT ID: NCT00245336
Last Updated: 2009-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
401 participants
INTERVENTIONAL
2005-10-31
2006-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
rThrombin
rThrombin
1000 U/mL applied topically in combination with absorbable gelatin sponge
2
bThrombin
bovine thrombin
1000 U/mL applied topically in combination with absorbable gelatin sponge
Interventions
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rThrombin
1000 U/mL applied topically in combination with absorbable gelatin sponge
bovine thrombin
1000 U/mL applied topically in combination with absorbable gelatin sponge
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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ZymoGenetics
INDUSTRY
Responsible Party
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ZymoGenetics, Inc.
Principal Investigators
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Thomas C Reynolds, MD, PhD
Role: STUDY_DIRECTOR
ZymoGenetics
William Chapman, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Kenneth Renkens, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana Spine Group
Fred Weaver, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Cardio Thoracic Surgeons, P.C.
Birmingham, Alabama, United States
Cardio Thoracic Surgeons, P.C., Medical Center East / Baptist Montclair
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Methodist Hospital
Arcadia, California, United States
Glendale Adventist Medical Center
Glendale, California, United States
University of Southern California, Keck School of Medicine
Los Angeles, California, United States
University of Southern California, Keck School of Medicine
Los Angeles, California, United States
Huntington Memorial Hospital
Pasadena, California, United States
Baptist Clinical Research
Pensacola, Florida, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Northwestern University Vascular Surgery
Chicago, Illinois, United States
Indiana Spine Group
Indianapolis, Indiana, United States
Bluegrass Orthopedics/Bluegrass Musculoskeletal Research
Lexington, Kentucky, United States
Vascular Surgery Associates
Baton Rouge, Louisiana, United States
Tulane University Abdominal Transplant
New Orleans, Louisiana, United States
VAMC Clinical Research Center
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Mt. Sinai School of Medicine
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of North Texas Science Center at Fort Worth
Fort Worth, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Physician's Research Options, LLC/The Intermountain Spine Institute
Murray, Utah, United States
University of Utah
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Harborview Medical Center
Seattle, Washington, United States
Countries
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References
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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.
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. doi: 10.1016/j.jamcollsurg.2007.03.020. Epub 2007 Jun 27.
Other Identifiers
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499E01
Identifier Type: -
Identifier Source: org_study_id
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