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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 events

Incidence 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

Page last updated: August 23, 2015

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