Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis

ZymoGenetics

Status and phase

Completed

Phase 3

Conditions

Spinal Surgery

Vascular Surgery

Treatments

Biological: rThrombin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00491608

499F04

Details and patient eligibility

About

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.

Full description

This is a Phase 3b, open-label, single-group, multisite safety and immunogenicity study of recombinant thrombin (rThrombin) in participants who are at least 18 years of age and undergoing spinal or vascular surgery. Eligible participants will receive topical rThrombin during surgery and complete a 1-month follow-up visit.

Enrollment

234 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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