Phase 4
N=97
Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin
Operation Site Bleed
Bottom Line
View on ClinicalTrials.gov: NCT00652314 ↗Enrolled (actual)
97
Serious AEs
16.5%
Results posted
Mar 2016
Primary outcome: Primary: The Primary Objective of This Investigation is to Gather Information to Support the Effectiveness of Thrombi-Gel as Compared to a Gelatin Sponge (Gelfoam) Plus Thrombin as an Adjunct to Hemostasis in Multi-specialty Surgical Settings. — 4.01; 3.72 Time to hemostasis (minutes)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Thrombi-Gel (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vascular Solutions LLC
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Primary Objective of This Investigation is to Gather Information to Support the Effectiveness of Thrombi-Gel as Compared to a Gelatin Sponge (Gelfoam) Plus Thrombin as an Adjunct to Hemostasis in Multi-specialty Surgical Settings. |
4.01; 3.72 | — |
| SECONDARY Effectiveness: Device Success (Defined as the Number of Subjects With First Bleeding Site Applications for Which Hemostasis Was Obtained Within 6 Minutes of Study Device Application Without the Need for Adjunctive Treatment) |
50; 29 | — |
| SECONDARY Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire) |
57; 29; 5; 4; 0; 0 | — |
| SECONDARY Safety: Incidence Rate of Device-related Adverse Events |
2; 0; 1; 0 | — |
| SECONDARY Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters |
11; 3; 17; 9; 11; 7 | — |
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 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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT00652314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.