Phase 4
N=31
Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis
Blood Loss, Surgical
Bottom Line
View on ClinicalTrials.gov: NCT00813904 ↗Enrolled (actual)
31
Serious AEs
19.4%
Results posted
Dec 2011
Primary outcome: Primary: Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29 — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- rThrombin, 1000 IU/mL (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ZymoGenetics
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29 |
0; 0 | — |
| SECONDARY 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 |
1; 6; 0; 29; 0; 0 | — |
| SECONDARY Number of Participants With AEs by Maximum Severity |
1; 18; 9; 0; 1 | — |
Summary
The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.
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
Data sourced from ClinicalTrials.gov (NCT00813904). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.