Status:
COMPLETED
Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin
Lead Sponsor:
Vascular Solutions LLC
Collaborating Sponsors:
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Conditions:
Operation Site Bleed
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This trial is designed as a prospective, multi-center, randomized, feasibility clinical trial to evaluate the safety and efficacy of Thrombi-Gel as an absorbable surgical hemostat. Within this clinic...
Detailed Description
This is a prospective, randomized, multi-center investigation with a minimum of seventy five (75) study subjects designed to evaluate the safety and effectiveness of the Thrombi-Gel product as an abso...
Eligibility Criteria
Inclusion
- The subject is 18 years of age or older
- The subject is undergoing an orthopedic/spinal, general, cardiac, hepatic, or vascular surgical procedure (neurosurgical, ophthalmic or urological procedures must be excluded)
- The subject is willing and able to provide appropriate informed consent
- The subject is willing and able to comply with the requirements of the study protocol, including the predefined follow-up evaluations
- Inclusion criteria to be determined during the surgical procedure:
- 1\. The subject has an intraoperative bleeding site which the surgeon is unable or unwilling to easily control with conventional methods (cautery, sutures)
Exclusion
- The subject is known or suspected to be pregnant (verified in a manner consistent with institution's standard of care), or is lactating
- The subject has a known allergy to bovine derived products or any other materials used in the Thrombi-Gel product
- The subject has an active infection at the surgical site
- The use of hemostatic agents are contraindicated for the subject
- The subject has a known bleeding disorder (including thrombocytopenia \[\< 100,000 platelet count\], thrombobasthenia, hemophilia, or von Willebrand disease)
- The subject has received antibiotic solutions/powders at the intended application site
- The subject has had surgery at the intended application site ≤ 6 months before the current surgical procedure
- The subject is unavailable for follow-up
- The subject is currently participating in another investigational device or drug trial
- The subject has previously participated in this trial (Protocol 0307) or the Thrombi-Paste trial (Protocol 0507)
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT00652314
Start Date
March 1 2008
End Date
January 1 2010
Last Update
March 7 2016
Active Locations (7)
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1
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 66702
2
Lahey Clinic
Burlington, Massachusetts, United States, 01805
3
Michigan Vascular Research Center
Flint, Michigan, United States, 48507
4
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601