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Study of Recombinant Human Thrombin for Bleeding During Surgery

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ClinicalTrials.gov Identifier: NCT00245336
Recruitment Status : Completed
First Posted : October 27, 2005
Last Update Posted : March 9, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Surgical Hemostasis Biological: rThrombin Drug: bovine thrombin Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2005
Primary Completion Date : June 2006
Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Time to hemostasis, as measured by the incidence of hemostasis within 10 minutes [ Time Frame: 10 minutes ]

Secondary Outcome Measures :
  1. Incidence and severity of adverse events [ Time Frame: Up to 29 days ]
  2. Incidence and grade of clinical laboratory abnormalities [ Time Frame: Up to 29 days ]
  3. Incidence of anti-product antibodies [ Time Frame: Up to 29 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 27, 2005    Key Record Dates
Last Update Posted: March 9, 2009
Last Verified: March 2009

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

Additional relevant MeSH terms:
Thrombin
Gelatin Sponge, Absorbable
Hemostatics
Coagulants