Study of Recombinant Human Thrombin for Bleeding During Surgery

Completed · Phase 3

Conditions studied: Surgical Hemostasis

In brief

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.

Key facts

Study ID

NCT00245336

Run by

ZymoGenetics

People needed

401

Starts

2005-10-01

Expected to finish

2006-07-01

Last updated by the study team

2009-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is undergoing spinal surgery, hepatic resection, peripheral arterial bypass surgery, or arteriovenous graft formation for hemodialysis access

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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