Loading clinical trials...

Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis

A Phase 3b, Open-Label, Single-Group Immunogenicity and Safety Study of Topical Recombinant Thrombin (rThrombin) in Surgical Hemostasis

NCT00491608•ZymoGenetics

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

Huntington Memorial Hospital

Pasadena, California, United States

Key Dates

Start Date

June 1, 2007

Primary Completion Date

July 1, 2008

Completion Date

July 1, 2008

Last Updated

January 13, 2012

Enrollment

234

ACTUAL participants

Conditions

Spinal SurgeryVascular Surgery

Interventions

rThrombin

BIOLOGICAL

Effects of Three Different Methods Applied to Patients After Spine Surgery on Nausea, Thirst and Comfort

NCT06857760

Spinal Surgery

View study

RECRUITINGNA

Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery in Brazil

NCT06601582

Cardiovascular SurgeryBlood Loss, Surgical

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis

Inclusion Criteria

Exclusion Criteria

Effects of Three Different Methods Applied to Patients After Spine Surgery on Nausea, Thirst and Comfort

Effectiveness of a Intraoperative Blood Recovery System in Cardiovascular Surgery in Brazil

Physiologic Signals and Signatures With the Accuryn Monitoring System - The Accuryn Registry

Australian and New Zealand Massive Transfusion Registry

Understanding How Methadone Treatment During Surgery Affects Pain Levels and the Need for Pain Medications After Surgery

Prediction of Arterial Hypotension by HPI: a Feasibility Study in Lung Resection Surgery and During Fenestrated Aortic Stenting Under General Anesthesia