Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis

Inclusion criteria

• Signed informed consent;
• Male or female ≥ 18 ages;
• Patients undergoing primary vascular surgery (i.e., conduit placement with an ePTFE graft), including the following:

• Arterio-arterial-bypass;

• Ilio-femoral bypass;
• Femoro-femoral bypass;
• Ilio-popliteal bypass;
• Femoro-popliteal bypass;
• Femoro-tibial vessel bypass
• Arteriovenous shunting for dialysis access in the upper or lower extremity;

Intraoperative inclusion criterion:

• Suture line bleeding eligible for study treatment is present after surgical hemostasis.

Exclusion criteria

• Concurrent participation in another clinical study treatment with another investigational drug or device within last 30 days;
• Other vascular procedures during the same surgical session;
• Arterio-arterial bypasses with more than two anastomoses;
• Haemoglobin <9.0 g/dL at screening;
• Pregnant or lactating women;
• Congenital or acquired coagulation disorders;
• Prior kidney transplantation;
• Heparin-induced thrombocytopenia;
• Known prior exposure to aprotinin within the last 12 months;
• Known hypersensitivity to aprotinin, heparin, blood products or other components of the investigational product;
• Unwilling to receive blood products.
• Known severe congenital or acquired immunodeficiency;
• Prior radiation therapy to the operating field;
• Severe local inflammation at the operating field;
• Positive results of any of the following the blood tests: HIV, syphilis, hepatitis B, hepatitis C.
• Emergency surgery.
• Alcohol or drug abuse.

Intraoperative exclusion criteria:

• Major intraoperative complications that required resuscitation or deviation from the planned surgical procedure;
• Intraoperative change in planned surgical procedure, which resulted in patient no longer meeting preoperative inclusion criteria or having preoperative exclusion criteria.