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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Surgical Hemostasis

Thank you

Trial Information

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


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.


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

Type of Study:

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

Outcome Measure:

Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes

Outcome Time Frame:

10 minutes

Safety Issue:

Yes

Principal Investigator

Thomas C Reynolds, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

ZymoGenetics

Authority:

United States: Food and Drug Administration

Study ID:

499E01

NCT ID:

NCT00245336

Start Date:

October 2005

Completion Date:

July 2006

Related Keywords:

  • Surgical Hemostasis
  • hemostasis
  • surgery
  • hemostatics
  • randomized controlled trial
  • phase 3

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Washington University School of MedicineSaint Louis, Missouri  63110
Northwestern Memorial HospitalChicago, Illinois  60611
Virginia Mason Medical CenterSeattle, Washington  98111
Harborview Medical CenterSeattle, Washington  98104
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
Huntington Memorial HospitalPasadena, California  91109-7013
University of VirginiaCharlottesville, Virginia  22908
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
University of UtahSalt Lake City, Utah  
Duke University Medical CenterDurham, North Carolina  27710
Glendale Adventist Medical CenterGlendale, California  91206
Mt. Sinai School of MedicineNew York, New York  10029
Cardio Thoracic Surgeons, P.C., Medical Center East / Baptist MontclairBirmingham, Alabama  35235
Cardio Thoracic Surgeons, P.C.Birmingham, Alabama  35213
Methodist HospitalArcadia, California  91007
University of Southern California, Keck School of MedicineLos Angeles, California  90033
Baptist Clinical ResearchPensacola, Florida  32501
Northwestern University Vascular SurgeryChicago, Illinois  60611
Indiana Spine GroupIndianapolis, Indiana  46260
Bluegrass Orthopedics/Bluegrass Musculoskeletal ResearchLexington, Kentucky  40509
Vascular Surgery AssociatesBaton Rouge, Louisiana  70809
Tulane University Abdominal TransplantNew Orleans, Louisiana  70112
VAMC Clinical Research CenterDetroit, Michigan  48201
University of North Texas Science Center at Fort WorthFort Worth, Texas  76107
Clinical Trials of TexasSan Antonio, Texas  78229
Physician's Research Options, LLC/The Intermountain Spine InstituteMurray, Utah  84107