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

  Show 29 Study Locations
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
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014