Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00813904
Recruitment Status : Completed
First Posted : December 23, 2008
Results First Posted : December 8, 2011
Last Update Posted : December 8, 2011
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Brief Summary:
The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.

Condition or disease Intervention/treatment Phase
Blood Loss, Surgical Biological: rThrombin, 1000 IU/mL Phase 4

Detailed Description:
The safety, immunogenicity, and efficacy of rThrombin have been evaluated in Phase 2 and Phase 3 studies in the following surgical indications: spinal surgery, major hepatic resection, peripheral arterial bypass (PAB) surgery, arteriovenous (AV) graft formation for hemodialysis access, and skin graft surgery following burn injury. Limited data on rThrombin reexposure currently exist. This study will assess the immunogenicity and safety of rThrombin in participants who are undergoing a surgical procedure during which topical rThrombin application is planned and who previously received rThrombin in Phase 3 clinical trials or during prior spine, AV graft formation, or PAB surgical procedures.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 4, Open-Label, Single-Group Immunogenicity and Safety Study of Re-exposure to RECOTHROM� (rThrombin) in Surgical Hemostasis
Study Start Date : January 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: rThrombin, 1000 IU/mL Biological: rThrombin, 1000 IU/mL
At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site, per product labeling.

Primary Outcome Measures :
  1. Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29 [ Time Frame: At baseline and Day 29 ]
    Immunogenicity of rThrombin product was evaluated using an enzyme-linked immunosorbent assay for detection of antirThrombin product antibody and a neutralizing antibody assay to characterize the potential of antibodies to rThrombin product to neutralize the activity of human plasma-derived thrombin.

Secondary Outcome Measures :
  1. Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs), Treatment-related Adverse Events, and AEs Leading to Discontinuation [ Time Frame: Baseline through Day 29, continuously ]
    An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.

  2. Number of Participants With AEs by Maximum Severity [ Time Frame: Baseline to Day 29, continuously ]
    An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AE severity was assessed using Common Terminology Criteria for Adverse Events, Version 13.0: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening; Grade 5=fatal.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previous enrollment in a ZymoGenetics-sponsored Phase 3 study and the recipient of treatment with rThrombin in that study or the recipient of commercially-available rThrombin in a prior spine, arteriovenous graft formation, or peripheral artery bypass surgical procedure
  • Age of 18 years or older at time of consent
  • Bleeding indicating treatment with rThrombin during the course of the surgical procedure
  • Signed informed consent document approved by an institutional review board or independent ethics committee

Exclusion Criteria:

  • Currently undergoing a procedure requiring cardiopulmonary bypass or involving the aortic arch
  • Known hypersensitivity to rThrombin product or any of its components
  • Currently undergoing a surgical procedure where the use of other thrombin-containing hemostatic agents is planned
  • Medical, social, or psychosocial factors that, in the opinion of the investigator, could affect the participant's safety or compliance with study procedures
  • Treatment with any experimental agent within 30 days of study enrollment or treatment

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 identifier (NCT number): NCT00813904

United States, Arizona
Tuscon Orthopaedic Institute
Tuscon, Arizona, United States, 85712
Sponsors and Collaborators
Principal Investigator: Neil Singla, MD Lotus Clinical Research

Responsible Party: ZymoGenetics Identifier: NCT00813904     History of Changes
Other Study ID Numbers: 499G02
First Posted: December 23, 2008    Key Record Dates
Results First Posted: December 8, 2011
Last Update Posted: December 8, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications