Back to resultsImmunogenicity and Safety Study of rThrombin in Surgical Hemostasis
Primary Purpose
Blood Loss, Surgical
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
rThrombin, 1000 IU/mL
Sponsored by
About this trial
This is an interventional treatment trial for Blood Loss, Surgical
Eligibility Criteria
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
Sites / Locations
- Tuscon Orthopaedic Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
rThrombin, 1000 IU/mL
Arm Description
Outcomes
Primary Outcome Measures
Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody 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
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
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.
Number of Participants With AEs by Maximum Severity
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00813904
Brief Title
Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis
Official Title
A Phase 4, Open-Label, Single-Group Immunogenicity and Safety Study of Re-exposure to RECOTHROM� (rThrombin) in Surgical Hemostasis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ZymoGenetics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
rThrombin, 1000 IU/mL
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
rThrombin, 1000 IU/mL
Other Intervention Name(s)
RECOTHROM
Intervention Description
At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site, per product labeling.
Primary Outcome Measure Information:
Title
Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29
Description
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.
Time Frame
At baseline and Day 29
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline through Day 29, continuously
Title
Number of Participants With AEs by Maximum Severity
Description
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.
Time Frame
Baseline to Day 29, continuously
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Singla, MD
Organizational Affiliation
Lotus Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tuscon Orthopaedic Institute
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis
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