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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 absorbable hemostat in the surgical patient population. Subjects who are undergoing orthopedic/spinal, general, cardiac, hepatic or vascular surgical procedures should be considered for this investigation. Subjects can be pre-screened utilizing standard of care data for the specified inclusion/exclusion criteria to ensure that they are eligible for treatment in the investigation. If the subject appears to qualify for the investigation, the subject will then be asked to give his/her written informed consent. If, during surgery, the surgeon encounters a bleeding site that he or she is unable or unwilling to easily control due to failure or impracticality of conventional methods (sutures and/or cautery), the subject may be enrolled and randomized to receive either the investigational or control treatment. If the subject has multiple bleeding sites, each site to a maximum of 5 sites, may be treated with the assigned surgical hemostat. However, only the first site treated will be used to determine study objectives. All subjects will be followed through their hospitalization. A follow-up evaluation will be conducted at approximately 30 and 60 days post-procedure to determine the long-term effectiveness of the hemostatic treatment received, incidence of late adverse events, and interim immunologic response to the study treatment device. Follow-up evaluations will include obtaining a blood specimen that evaluates for antibody development, coagulation, and Factor Va testing. Blood samples will be sent to independent labs for analysis. From baseline to the final study exam, data pertaining to the investigational objectives will be recorded on the appropriate case report forms at the predetermined study intervals. The investigation will be conducted at a minimum of five (5) sites, but no more than fifteen (15) sites.

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

Conditions
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Operation Site Bleed

Intervention / Treatment
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* Device: Thrombi-Gel


Participation Criteria
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Eligibility Criteria
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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: 1. 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 - Thrombi-gel treatment<br>Thrombi-gel treatment | Device: Thrombi-Gel<br>* Applicaton of Hemostatic product during surgery<br>* Other names: Gelatin Sponge (Gelfoam) plus thrombin;|
| Active Comparator: 2 - Gelatin Sponge (Gelfoam)<br>Gelatin Sponge (Gelfoam) plus thrombin | Device: Thrombi-Gel<br>* Applicaton of Hemostatic product during surgery<br>* Other names: Gelatin Sponge (Gelfoam) plus thrombin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Evaluation for hemostasis began immediately following application of the safety product. Hemostasis assessments were to be made every minute for the first 10 minutes post application. If hemostasis was not observed within 10 minutes, the treatment site was to be monitored and the research teams were asked to record the specific number of minutes until hemostasis was observed. | Time to hemostasis (minutes) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | Procedure, up to 6 minutes post procedure | 
| Effectiveness: Hemostatic Handling Characteristics (Surgeon's Questionnaire) | Ease of application to bleeding site as assessed by surgeon questionnaire for hemostatic handling characteristics. | Procedure (application through end of procedure) | 
| Safety: Incidence Rate of Device-related Adverse Events |  | Procedure, up to 60 days post procedure | 
| Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters |  | 0 day, 30 day, and 60 days post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemostatic products, Surgical hemostasis, Thrombi-gel, Gelatin Sponge, Time to hemostasis