Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis
Completed · Phase 3
Conditions studied: Spinal Surgery, Vascular Surgery
In brief
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.
Key facts
- Study ID
- NCT00491608
- Run by
- ZymoGenetics
- People needed
- 234
- Starts
- 2007-06-01
- Expected to finish
- 2008-07-01
- Last updated by the study team
- 2012-01-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Huntington Memorial Hospital — Pasadena, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.