Phase 3
N=209
Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis
Spinal Surgery · Vascular Surgery
Bottom Line
View on ClinicalTrials.gov: NCT00491608 ↗Enrolled (actual)
209
Serious AEs
22.5%
Results posted
Jan 2012
Primary outcome: Primary: Number of Participants With Anti-recombinant Thrombin (rThrombin) Product Antibodies at Day 29 in Participants With and Without Anti-bovine Thrombin Product Antibodies at Baseline — 0; 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- rThrombin (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ZymoGenetics
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Anti-recombinant Thrombin (rThrombin) Product Antibodies at Day 29 in Participants With and Without Anti-bovine Thrombin Product Antibodies at Baseline |
0; 0; 0 | — |
| SECONDARY Number of Participants With Death as Outcome, Serious Adverse Events, Treatment-related Adverse Events (AEs), and Treatment-emergent AEs |
2; 47; 4; 76; 0 | — |
| SECONDARY Number of Participants With Abnormal Hematology Laboratory Results of Common Terminology Criteria (CTC) Grade 2 or Higher at Baseline and Day 29 |
13; 12; 3; 0; 0; 0 | — |
| SECONDARY Number of Participants With Elevations in Coagulation Parameters of CTC Grade 3 or Higher at Baseline and Day 29 |
6; 7; 1; 1 | — |
| SECONDARY Number of Participants With Abnormal Laboratory Results in Median Levels of Immunoglobulin A, G, and M at Baseline or Day 29 |
— | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Mean Values for Vital Signs (Temperature, Systolic Blood Pressure, Diastolic Blood Pressure, Respiration Rate, Heart Rate) at Baseline and Day 29 |
— | — |
Summary
The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.
Eligibility Criteria
Inclusion Criteria
- Currently undergoing cervical, thoracic, or lumbar discectomy; corpectomy, laminectomy, lateral or interbody fusion, including both anterior and posterior approaches (not including minimally invasive procedures; arterial reconstruction; peripheral artery bypass (PAB) grafting; or arteriovenous (AV) vascular access procedures
- History of surgery with high likelihood of exposure to bovine thrombin within the past 3 years. Prior surgery must have been 1 of the following open procedures: open procedures involving the spine or cranium, PAB grafting, AV vascular access procedures, autologous skin grafting, or other surgical procedure accompanied by documented treatment with bovine thrombin
- Age of 18 years or younger at time of informed consent
- If female and of child-bearing potential: Negative pregnancy test result within 14 days prior to treatment
- Use of a medically accepted form of contraception from the time of informed consent to completion of all follow-up study visits, if sexually active male or a sexually active female of childbearing potential
- Signed IRB/independent ethics committee-approved informed consent document
Exclusion Criteria
- Currently undergoing procedures requiring cardiopulmonary bypass or involving the aortic arch
- Known hypersensitivity to rThrombin or any of its components
- Presence of medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
- Breastfeeding
- Receipt of treatment with any experimental agent within 30 days of study enrollment or treatment
Data sourced from ClinicalTrials.gov (NCT00491608). 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.