Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin

Completed · Phase 4

Conditions studied: Operation Site Bleed

In brief

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 clinical evaluation, Thrombi-Gel will be compared to the current standard of care, a gelatin sponge (Gelfoam) plus Thrombin JMI, by using a 2:1 randomization ratio. Subjects will be randomized to one of two (2) treatment groups. One (1) group will be treated with Thrombi-Gel, while one (1) group will be treated with the gelatin sponge plus thrombin. All study data will be analyzed according to the subjects' assigned randomization group assignment, regardless of the treatment actually delivered.

Key facts

Study ID

NCT00652314

Run by

Vascular Solutions LLC

People needed

97

Starts

2008-03-01

Expected to finish

2010-01-01

Last updated by the study team

2016-03-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• The subject has an intraoperative bleeding site which the surgeon is unable or unwilling to easily control with conventional methods (cautery, sutures)

You may not qualify if…

• 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)

Where it is running

• Southern Illinois University School of Medicine — Springfield, Illinois, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• Michigan Vascular Research Center — Flint, Michigan, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Sanford Clinic — Sioux Falls, South Dakota, United States
• Southwest Regional Clinical Research — Lubbock, Texas, United States
• Texas Tech University Health Sciences Center — Lubbock, Texas, United States

Full record on ClinicalTrials.gov

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