Status:
COMPLETED
FS VH S/D 500 S-apr in Vascular Surgery
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses
Eligibility:
All Genders
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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.)
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT00892957
Start Date
July 1 2009
End Date
November 1 2010
Last Update
November 27 2012
Active Locations (22)
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1
Birmingham, Alabama, United States
2
Tucson, Arizona, United States
3
Fresno, California, United States
4
Orange, California, United States