Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
176 participants
INTERVENTIONAL
2009-07-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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FS VH S/D 500 s-apr
FS VH S/D 500 s-apr will be applied to the study suture line.
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)
The actual dose of FS VH S/D 500 s-apr will depend on the length of the suture line and the intensity of bleeding (but shall not exceed 4 mL FS VH S/D 500 s-apr).
Manual compression with surgical gauze pads
Dry gauze pads will be positioned to cover the complete study suture line.
Surgical gauze pads
Manual compression with surgical gauze pads
Interventions
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Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)
The actual dose of FS VH S/D 500 s-apr will depend on the length of the suture line and the intensity of bleeding (but shall not exceed 4 mL FS VH S/D 500 s-apr).
Surgical gauze pads
Manual compression with surgical gauze pads
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* axillo-femoral
* axillo-bifemoral
* aorto-bifemoral
* ilio-femoral
* femoro-femoral
* ilio-popliteal
* femoro-popliteal (including below knee)
* femoro-tibial vessel bypass
* arterio-venous shunting for dialysis access in the upper or lower extremity
* Signed informed consent
* Subject is of childbearing potential, presents with a negative serum or urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study.
* Subject is willing and able to comply with the requirements of the protocol.
Intraoperative inclusion criterion:
* Suture line bleeding eligible for study treatment is present after surgical hemostasis (ie, suturing). (A definition of eligible suture line bleeding is provided in the study protocol.)
Exclusion Criteria
* Congenital coagulation disorders
* Prior kidney transplantation
* Heparin-induced thrombocytopenia
* Known hypersensitivity to heparin
* Known hypersensitivity to aprotinin or other components of the product
* Known severe congenital or acquired immunodeficiency (eg, HIV infection or long-term treatment with immunosuppressive drugs (eg, organ transplantation patients)
* Prior radiation therapy to the operating field
* Severe local inflammation at the operating field
* Subject is pregnant or lactating at the time of enrollment
* Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
* Subject has previously participated in this study (Protocol No.: 550801), ie, each subject can only be enrolled once.
* Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
ALL
No
Sponsors
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Baxter Healthcare Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Isabella Presch, MD, MBA
Role: STUDY_DIRECTOR
Baxter Innovations GmbH
Locations
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Birmingham, Alabama, United States
Tucson, Arizona, United States
Fresno, California, United States
Orange, California, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Melbourne, Florida, United States
Fort Wayne, Indiana, United States
Lexington, Kentucky, United States
Baton Rouge, Louisiana, United States
Saginaw, Michigan, United States
Southfield, Michigan, United States
Hackensack, New Jersey, United States
Buffalo, New York, United States
The Bronx, New York, United States
Dayton, Ohio, United States
Pittsburgh, Pennsylvania, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Bellevue, Washington, United States
Seattle, Washington, United States
Countries
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References
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Saha SP, Muluk S, Schenk W 3rd, Dennis JW, Ploder B, Grigorian A, Presch I, Goppelt A. A prospective randomized study comparing fibrin sealant to manual compression for the treatment of anastomotic suture-hole bleeding in expanded polytetrafluoroethylene grafts. J Vasc Surg. 2012 Jul;56(1):134-41. doi: 10.1016/j.jvs.2012.01.009. Epub 2012 May 25.
Other Identifiers
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550801
Identifier Type: -
Identifier Source: org_study_id