Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis

NCT ID: NCT00491608

Last Updated: 2012-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 234 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2008-07-31

Brief 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.

Conditions

Spinal Surgery; Vascular Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

rThrombin

Group Type: EXPERIMENTAL

rThrombin

Intervention Type: BIOLOGICAL

1000 U/mL applied directly or in combination with absorbable gelatin sponge or powder

Interventions

rThrombin

1000 U/mL applied directly or in combination with absorbable gelatin sponge or powder

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ZymoGenetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allan Alexander, MD, CPI

Role: STUDY_DIRECTOR

ZymoGenetics

Locations

Huntington Memorial Hospital

Pasadena, California, United States

Countries

United States

References

Randleman CD Jr, Singla NK, Renkens KL, Souza S, Pribble JP, Alexander WA. Persistence of antibodies to the topical hemostat bovine thrombin. J Am Coll Surg. 2010 Dec;211(6):798-803. doi: 10.1016/j.jamcollsurg.2010.07.023. Epub 2010 Oct 25.

Reference Type: DERIVED

PMID: 20980172 (View on PubMed)

Singla NK, Ballard JL, Moneta G, Randleman CD Jr, Renkens KL, Alexander WA. A phase 3b, open-label, single-group immunogenicity and safety study of topical recombinant thrombin in surgical hemostasis. J Am Coll Surg. 2009 Jul;209(1):68-74. doi: 10.1016/j.jamcollsurg.2009.03.016. Epub 2009 May 28.

Reference Type: DERIVED

PMID: 19651065 (View on PubMed)

Other Identifiers

499F04

Identifier Type: -

Identifier Source: org_study_id