Study of Recombinant Human Thrombin for Bleeding During Surgery

March 6, 2009 updated by: ZymoGenetics

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

401

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
      • Birmingham, Alabama, United States, 35213
        • Cardio Thoracic Surgeons, P.C.
      • Birmingham, Alabama, United States, 35235
        • Cardio Thoracic Surgeons, P.C., Medical Center East / Baptist Montclair
    • California
      • Arcadia, California, United States, 91007
        • Methodist Hospital
      • Glendale, California, United States, 91206
        • Glendale Adventist Medical Center
      • Los Angeles, California, United States, 90033
        • University of Southern California, Keck School of Medicine
      • Los Angeles, California, United States, 90333
        • University of Southern California, Keck School of Medicine
      • Pasadena, California, United States, 91105
        • Huntington Memorial Hospital
    • Florida
      • Pensacola, Florida, United States, 32501
        • Baptist Clinical Research
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60611
        • Northwestern University Vascular Surgery
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Indiana Spine Group
    • Kentucky
      • Lexington, Kentucky, United States, 40509
        • Bluegrass Orthopedics/Bluegrass Musculoskeletal Research
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Vascular Surgery Associates
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Abdominal Transplant
    • Michigan
      • Detroit, Michigan, United States, 48201
        • VAMC Clinical Research Center
    • Missouri
      • St. Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New York
      • New York, New York, United States, 10029
        • Mt. Sinai School of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Fort Worth, Texas, United States, 76107
        • University of North Texas Science Center at Fort Worth
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas
    • Utah
      • Murray, Utah, United States, 84107
        • Physician's Research Options, LLC/The Intermountain Spine Institute
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Thrombin-JMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes
Time Frame: 10 minutes
10 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of adverse events
Time Frame: Up to 29 days
Up to 29 days
Incidence and grade of clinical laboratory abnormalities
Time Frame: Up to 29 days
Up to 29 days
Incidence of anti-product antibodies
Time Frame: Up to 29 days
Up to 29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZymoGenetics

Investigators

  • Study Director: Thomas C Reynolds, MD, PhD, ZymoGenetics
  • Principal Investigator: Kenneth Renkens, MD, Indiana Spine Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (ACTUAL)

June 1, 2006

Study Completion (ACTUAL)

July 1, 2006

Study Registration Dates

First Submitted

October 25, 2005

First Submitted That Met QC Criteria

October 25, 2005

First Posted (ESTIMATE)

October 27, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 9, 2009

Last Update Submitted That Met QC Criteria

March 6, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 499E01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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