Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin
NCT00652314
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
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)
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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Descriptive Information | ||||
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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 |
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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 | 97 | |||
Original Estimated Enrollment ICMJE | 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:
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:
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Sex/Gender ICMJE |
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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 |
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Responsible Party | Vascular Solutions LLC | |||
Study Sponsor ICMJE | Vascular Solutions LLC | |||
Collaborators ICMJE | King Pharmaceuticals is now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
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PRS Account | Vascular Solutions LLC | |||
Verification Date | February 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |