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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Vascular Solutions, Inc.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Information provided by:
Vascular Solutions, Inc
ClinicalTrials.gov Identifier:
NCT00652314
First received: March 28, 2008
Last updated: February 23, 2011
Last verified: February 2011
  Purpose

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 Intervention Phase
Surgical Intervention Hemostasis
Comparison of Surgical Hemostats
Device: Thrombi-Gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin

Resource links provided by NLM:


Further study details as provided by Vascular Solutions, Inc:

Primary Outcome Measures:
  • 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: 30 day, 60 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effectiveness: Device success (defined as the percentage of 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 ] [ Designated as safety issue: No ]
  • Effectiveness: Hemostatic handling characteristics (surgeon's questionnaire) [ Time Frame: Procedure ] [ Designated as safety issue: No ]
  • Safety: Incidence rate of device-related adverse events [ Time Frame: Procedure, 30 Day, 60 Day ] [ Designated as safety issue: Yes ]
  • Safety: Immunological testing for factor Va antibodies and coagulation parameters [ Time Frame: 30 day, 60 day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 75
Study Start Date: March 2008
Estimated Study Completion Date: December 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Thrombi-gel treatment
Device: Thrombi-Gel
Applicaton of Hemostatic product during surgery
Other Names:
  • Thrombi-gel
  • Gelatin Sponge (Gelfoam) plus thrombin
Active Comparator: 2
Gelatin Sponge (Gelfoam) plus thrombin
Device: Thrombi-Gel
Applicaton of Hemostatic product during surgery
Other Names:
  • Thrombi-gel
  • Gelatin Sponge (Gelfoam) plus thrombin

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652314

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
Texas Tech University Health Sciences Center
Lubbock, Texas, United States, 79415
Southwest Regional Clinical Research
Lubbock, Texas, United States, 79412
Sponsors and Collaborators
Vascular Solutions, Inc
King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Robert Dolan, MD Lahey Clinic
  More Information

No publications provided

Responsible Party: Melinda Swanson, Vascular Solutions Inc.
ClinicalTrials.gov Identifier: NCT00652314     History of Changes
Other Study ID Numbers: 0307, The CONTROL Study
Study First Received: March 28, 2008
Last Updated: February 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Vascular Solutions, Inc:
Hemostatic products
Surgical hemostasis
Thrombi-gel
Gelatin Sponge
Time to hemostasis

Additional relevant MeSH terms:
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombin
Gelatin Sponge, Absorbable
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 22, 2014