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

Baxter

Status and phase

Completed

Phase 3

Conditions

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

Treatments

Biological: Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)

Other: Surgical gauze pads

Study type

Interventional

Funder types

Industry

Identifiers

NCT00892957

550801

Details and patient eligibility

About

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.

Enrollment

176 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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)