FS VH S/D 500 S-apr in Vascular Surgery

Completed · Phase 3

Conditions studied: Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses

In brief

The purpose of this study was to compare safety and efficacy of FS VH S/D 500 s-apr (FS) versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft placement.

Key facts

Study ID

NCT00892957

Run by

Baxter Healthcare Corporation

People needed

176

Starts

2009-07-01

Expected to finish

2010-11-01

Last updated by the study team

2012-11-27

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Preoperative inclusion criteria:
• Subjects undergoing vascular surgery (ie, conduit placement with an ePTFE graft), including arterio-arterial bypasses, including:
• 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.)

You may not qualify if…

• Preoperative exclusion criteria:
• Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)
• 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.
• Intraoperative Exclusion Criteria:
• Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
• Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria, (eg, abandonment of ePTFE graft placement)

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Tucson, Arizona, United States
• Study site — Fresno, California, United States
• Study site — Orange, California, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Jacksonville, Florida, United States
• Study site — Melbourne, Florida, United States
• Study site — Fort Wayne, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Baton Rouge, Louisiana, United States
• Study site — Saginaw, Michigan, United States
• Study site — Southfield, Michigan, United States
• Study site — Hackensack, New Jersey, United States
• Study site — Buffalo, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Dayton, Ohio, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — San Antonio, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Charlottesville, Virginia, United States
• Study site — Bellevue, Washington, United States
• Study site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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