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

• ClinicalTrials.gov Identifier: NCT00652314
• Recruitment Status: Completed
• First Posted: April 3, 2008
• Results First Posted: March 7, 2016
• Last Update Posted: March 7, 2016
• Sponsor: Vascular Solutions LLC
• Collaborator: King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
• Information provided by (Responsible Party): Vascular Solutions LLC

Study Description

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 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.

Condition or disease	Intervention/treatment	Phase
Operation Site Bleed	Device: Thrombi-Gel	Phase 4

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 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin
• Study Start Date: March 2008
• Actual Primary Completion Date: October 2009
• Actual Study Completion Date: January 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1 - Thrombi-gel treatment; Thrombi-gel treatment	Device: Thrombi-Gel; Applicaton of Hemostatic product during surgery; Other Name: Gelatin Sponge (Gelfoam) plus thrombin
Active Comparator: 2 - Gelatin Sponge (Gelfoam); Gelatin Sponge (Gelfoam) plus thrombin	Device: Thrombi-Gel; Applicaton of Hemostatic product during surgery; Other Name: Gelatin Sponge (Gelfoam) plus thrombin

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: Time to hemostasis (minutes) ]
   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.

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. The subject is 18 years of age or older
2. The subject is undergoing an orthopedic/spinal, general, cardiac, hepatic, or vascular surgical procedure (neurosurgical, ophthalmic or urological procedures must be excluded)
3. The subject is willing and able to provide appropriate informed consent
4. 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:

1. The subject is known or suspected to be pregnant (verified in a manner consistent with institution's standard of care), or is lactating
2. The subject has a known allergy to bovine derived products or any other materials used in the Thrombi-Gel product
3. The subject has an active infection at the surgical site
4. The use of hemostatic agents are contraindicated for the subject
5. The subject has a known bleeding disorder (including thrombocytopenia [< 100,000 platelet count], thrombobasthenia, hemophilia, or von Willebrand disease)
6. The subject has received antibiotic solutions/powders at the intended application site
7. The subject has had surgery at the intended application site ≤ 6 months before the current surgical procedure
8. The subject is unavailable for follow-up
9. The subject is currently participating in another investigational device or drug trial
10. The subject has previously participated in this trial (Protocol 0307) or the Thrombi-Paste trial (Protocol 0507)

Contacts and Locations

Locations

United States, Illinois

Southern Illinois University School of Medicine

Springfield, Illinois, United States, 66702

United States, Massachusetts

Lahey Clinic

Burlington, Massachusetts, United States, 01805

United States, Michigan

Michigan Vascular Research Center

Flint, Michigan, United States, 48507

United States, New Jersey

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

United States, South Dakota

Sanford Clinic

Sioux Falls, South Dakota, United States, 57104

United States, Texas

Southwest Regional Clinical Research

Lubbock, Texas, United States, 79412

Texas Tech University Health Sciences Center

Lubbock, Texas, United States, 79415

Sponsors and Collaborators

Vascular Solutions LLC

King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Investigators

• Principal Investigator: Robert Dolan, MD; Lahey Clinic

More Information

• Responsible Party: Vascular Solutions LLC
• ClinicalTrials.gov Identifier: NCT00652314
• Other Study ID Numbers: 0307; The CONTROL Study ( Other Identifier: Vascular Solutions )
• First Posted: April 3, 2008
• Results First Posted: March 7, 2016
• Last Update Posted: March 7, 2016
• Last Verified: February 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Vascular Solutions LLC:

Hemostatic products; Surgical hemostasis; Thrombi-gel; Gelatin Sponge; Time to hemostasis

Additional relevant MeSH terms:

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombin; Hemostatics; Coagulants