Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2007-12-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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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 - 60-Seconds
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) will be applied to the study suture line, 60-second polymerization time
FS VH S/D 500 s-apr, 60-seconds polymerization time
FS VH S/D 500 s-apr (FS) is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr.
FS VH S/D 500 s-apr - 120-Seconds
FS VH S/D 500 s-apr will be applied to the study suture line, 120-second polymerization time
FS VH S/D 500 s-apr, 120-seconds polymerization time
Treatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps.
Control Group- Manual compression with surgical gauze pads
Treatment of the study-suture line will be manual compression with surgical gauze pads.
Manual compression with surgical gauze pads
Treatment of the study suture line with manual compression with surgical gauze pads.
Interventions
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FS VH S/D 500 s-apr, 60-seconds polymerization time
FS VH S/D 500 s-apr (FS) is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr.
FS VH S/D 500 s-apr, 120-seconds polymerization time
Treatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps.
Manual compression with surgical gauze pads
Treatment of the study suture line with manual compression with surgical gauze pads.
Eligibility Criteria
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Inclusion Criteria
* Subject undergoing peripheral vascular surgery, ie, conduit placement with an ePTFE graft such as arterio-arterial bypasses \[including: axillo-femoral, ilio-femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass\], or arteriovenous dialysis access shunt in the upper or lower extremity.
* Signed informed consent
Intraoperative inclusion criterion:
\- Suture line bleeding eligible for study treatment is present after surgical hemostasis (i.e., suturing).
Suture line bleeding eligible for study treatment is defined as: any suture line bleeding that would prevent immediate closure of the wound and require treatment of the bleeding first, and on a scale of mild, moderate, and severe, the suture line bleeding is assessed as moderate or severe. (Moderate is defined as: either more than 25% of the suture line bleeds, or at least 5 suture line bleedings are present, if counting of suture line bleedings is possible, or one pulsatile suture line bleeding is present. Severe is defined as: either more than 50% of the suture line bleeds, or at least 10 suture line bleedings present, if counting of suture line bleedings is possible, or more than one pulsatile suture line bleedings are present, or at least one spurting suture line bleeding is present.)
Exclusion Criteria
* Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)
* Arterio-arterial bypasses with more than 2 anastomoses (e.g., aorto-bifemoral, axillo-bifemoral etc.)
* Pregnant or lactating women
* Congenital coagulation disorders
* Prior kidney transplantation
* Heparin-induced thrombocytopenia
* Known prior exposure to aprotinin within the last 12 months
* Known hypersensitivity to aprotinin or other components of the product
* Known severe congenital or acquired immunodeficiency (e.g., HIV infection or long term treatment with immunosuppressive drugs)
* Prior radiation therapy to the operating field
* Severe local inflammation at the operating field.
Intraoperative exclusion criterion:
* 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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Locations
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Birmingham, Alabama, United States
Tucson, Arizona, United States
Long Beach, California, United States
Jacksonville, Florida, United States
Lexington, Kentucky, United States
Baton Rouge, Louisiana, United States
Pittsburgh, Pennsylvania, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Virginia Beach, Virginia, United States
Seattle, Washington, United States
Countries
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References
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Saha SP, Muluk S, Schenk W 3rd, Burks SG, Grigorian A, Ploder B, Presch I, Pavlova BG, Hantak E. Use of fibrin sealant as a hemostatic agent in expanded polytetrafluoroethylene graft placement surgery. Ann Vasc Surg. 2011 Aug;25(6):813-22. doi: 10.1016/j.avsg.2010.12.016. Epub 2011 Apr 21.
Other Identifiers
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550602
Identifier Type: -
Identifier Source: org_study_id