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

October 25, 2005
March 6, 2009
October 2005
June 2006   (final data collection date for primary outcome measure)
Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes [ Time Frame: 10 minutes ] [ Designated as safety issue: Yes ]
Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes
Complete list of historical versions of study NCT00245336 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Incidence and severity of adverse events
  • Incidence and grade of clinical laboratory abnormalities
  • Incidence of anti-product antibodies
Not Provided
Not Provided
 
Study of Recombinant Human Thrombin for Bleeding During Surgery
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Surgical Hemostasis
  • Biological: rThrombin
    1000 U/mL applied topically in combination with absorbable gelatin sponge
  • Drug: bovine thrombin
    1000 U/mL applied topically in combination with absorbable gelatin sponge
    Other Name: Thrombin-JMI
  • Experimental: 1
    rThrombin
    Intervention: Biological: rThrombin
  • Active Comparator: 2
    bThrombin
    Intervention: Drug: bovine thrombin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
401
July 2006
June 2006   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00245336
499E01
Yes
Allan Alexander, MD, ZymoGenetics, Inc.
ZymoGenetics
Not Provided
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
ZymoGenetics
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP