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

NCT00652314

Last updated date
Study Location
Southern Illinois University School of Medicine
Springfield, Illinois, 66702, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Operation Site Bleed
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


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)

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Operation Site BleedEvaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin
NCT00652314
  1. Springfield, Illinois
  2. Burlington, Massachusetts
  3. Flint, Michigan
  4. Hackensack, New Jersey
  5. Sioux Falls, South Dakota
  6. Lubbock, Texas
  7. Lubbock, Texas
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin
Official Title  ICMJE Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Operation Site Bleed
Intervention  ICMJE Device: Thrombi-Gel
Applicaton of Hemostatic product during surgery
Other Name: Gelatin Sponge (Gelfoam) plus thrombin
Study Arms  ICMJE
  • Experimental: 1 - Thrombi-gel treatment
    Thrombi-gel treatment
    Intervention: Device: Thrombi-Gel
  • Active Comparator: 2 - Gelatin Sponge (Gelfoam)
    Gelatin Sponge (Gelfoam) plus thrombin
    Intervention: Device: Thrombi-Gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 5, 2016)
97
Original Estimated Enrollment  ICMJE
 (submitted: March 28, 2008)
75
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00652314
Other Study ID Numbers  ICMJE 0307
The CONTROL Study ( Other Identifier: Vascular Solutions )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Vascular Solutions, Inc
Study Sponsor  ICMJE Vascular Solutions, Inc
Collaborators  ICMJE King Pharmaceuticals is now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Robert Dolan, MDLahey Clinic
PRS Account Vascular Solutions, Inc
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP