Study of Recombinant Human Thrombin for Bleeding During Surgery
Information source: ZymoGenetics
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Surgical Hemostasis
Intervention: rThrombin (Biological); bovine thrombin (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: ZymoGenetics Official(s) and/or principal investigator(s): Thomas C Reynolds, MD, PhD, Study Director, Affiliation: ZymoGenetics William Chapman, MD, Principal Investigator, Affiliation: Washington University School of Medicine Kenneth Renkens, MD, Principal Investigator, Affiliation: Indiana Spine Group Fred Weaver, MD, Principal Investigator, Affiliation: University of Southern California
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes
Secondary outcome: Incidence and severity of adverse eventsIncidence and grade of clinical laboratory abnormalities Incidence of anti-product antibodies
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
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
Harborview Medical Center, Seattle, Washington 98104, United States
Virginia Mason Medical Center, Seattle, Washington 98101, United States
Additional Information
Starting date: October 2005
Last updated: March 6, 2009
|