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

NCT00652314 | Completed Phase 4 Results

• 2 other identifiers: 0307The CONTROL Study
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 7

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.

Conditions

Operation Site Bleed

Keywords

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

Outcome Measures

Primary Outcomes (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.

  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 Outcomes (4)

• 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)

  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

Study Arms (2)

1 - Thrombi-gel treatment

EXPERIMENTAL

Thrombi-gel treatment

Device: Thrombi-Gel

2 - Gelatin Sponge (Gelfoam)

ACTIVE COMPARATOR

Gelatin Sponge (Gelfoam) plus thrombin

Device: Thrombi-Gel

Interventions

Thrombi-Gel DEVICE

Applicaton of Hemostatic product during surgery

Also known as: Gelatin Sponge (Gelfoam) plus thrombin

1 - Thrombi-gel treatment; 2 - Gelatin Sponge (Gelfoam)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• \. 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)

Sponsors & Collaborators

• Vascular Solutions LLC: lead
• King Pharmaceuticals is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (7)

Southern Illinois University School of Medicine

Springfield, Illinois, 66702, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Michigan Vascular Research Center

Flint, Michigan, 48507, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Sanford Clinic

Sioux Falls, South Dakota, 57104, United States

Location

Southwest Regional Clinical Research

Lubbock, Texas, 79412, United States

Location

Texas Tech University Health Sciences Center

Lubbock, Texas, 79415, United States

Location

MeSH Terms

Interventions

Gelatin Sponge, Absorbable

Intervention Hierarchy (Ancestors)

Surgical Sponges; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Lisa Gallatin, RAC
• Organization: Vascular Solutions, Inc.

lgallatin@vasc.com

763-656-4399

Study Officials

• Robert Dolan, MD

  Lahey Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2008
• First Posted: April 3, 2008
• Study Start: March 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: January 1, 2010
• Last Updated: March 7, 2016
• Results First Posted: March 7, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)