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

February 5, 2016 updated by: Vascular Solutions LLC

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

97

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Springfield, Illinois, United States, 66702
        • Southern Illinois University School of Medicine
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
    • Michigan
      • Flint, Michigan, United States, 48507
        • Michigan Vascular Research Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Clinic
    • Texas
      • Lubbock, Texas, United States, 79412
        • Southwest Regional Clinical Research
      • Lubbock, Texas, United States, 79415
        • Texas Tech University Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1 - Thrombi-gel treatment
Thrombi-gel treatment
Device: Thrombi-Gel
Applicaton of Hemostatic product during surgery
Other Names:
  • 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 Names:
  • Gelatin Sponge (Gelfoam) plus thrombin

What is the study measuring?

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.
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.
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)
Time Frame: Procedure, up to 6 minutes post procedure
Procedure, up to 6 minutes post procedure
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.
Procedure (application through end of procedure)
Safety: Incidence Rate of Device-related Adverse Events
Time Frame: Procedure, up to 60 days post procedure
Procedure, up to 60 days post procedure
Safety: Immunological Testing for Factor Va Antibodies and Coagulation Parameters
Time Frame: 0 day, 30 day, and 60 days post procedure
0 day, 30 day, and 60 days post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vascular Solutions LLC

Collaborators

King Pharmaceuticals is now a wholly owned subsidiary of Pfizer

Investigators

  • Principal Investigator: Robert Dolan, MD, Lahey Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

March 28, 2008

First Submitted That Met QC Criteria

March 28, 2008

First Posted (ESTIMATE)

April 3, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 7, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0307
  • The CONTROL Study (OTHER: Vascular Solutions)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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