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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00652314
Recruitment Status : Completed
First Posted : April 3, 2008
Results First Posted : March 7, 2016
Last Update Posted : March 7, 2016
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Vascular Solutions, Inc

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.

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Clots

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00652314

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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, Inc
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
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Principal Investigator: Robert Dolan, MD Lahey Clinic
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Responsible Party: Vascular Solutions, Inc Identifier: NCT00652314    
Other Study ID Numbers: 0307
The CONTROL Study ( Other Identifier: Vascular Solutions )
First Posted: April 3, 2008    Key Record Dates
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, Inc:
Hemostatic products
Surgical hemostasis
Gelatin Sponge
Time to hemostasis
Additional relevant MeSH terms:
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Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases