Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Baxter Healthcare Corporation
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female of all ages
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.)
You may not be if
Subjects concurrently participating in another clinical study treatment with another investigational drug or device within the last 30 days
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.
