Study of Recombinant Human Thrombin for Bleeding During Surgery

This study has been completed.
Sponsor:
Information provided by:
ZymoGenetics
ClinicalTrials.gov Identifier:
NCT00245336
First received: October 25, 2005
Last updated: March 6, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Surgical Hemostasis
Biological: rThrombin
Drug: bovine thrombin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by ZymoGenetics:

Primary Outcome Measures:
  • Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence and severity of adverse events [ Time Frame: Up to 29 days ] [ Designated as safety issue: Yes ]
  • Incidence and grade of clinical laboratory abnormalities [ Time Frame: Up to 29 days ] [ Designated as safety issue: Yes ]
  • Incidence of anti-product antibodies [ Time Frame: Up to 29 days ] [ Designated as safety issue: Yes ]

Enrollment: 401
Study Start Date: October 2005
Study Completion Date: July 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Thrombin-JMI

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245336

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

No publications provided by ZymoGenetics

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allan Alexander, MD, ZymoGenetics, Inc.
ClinicalTrials.gov Identifier: NCT00245336     History of Changes
Other Study ID Numbers: 499E01
Study First Received: October 25, 2005
Last Updated: March 6, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by ZymoGenetics:
hemostasis
surgery
hemostatics
randomized controlled trial
phase 3

Additional relevant MeSH terms:
Thrombin
Gelatin Sponge, Absorbable
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014