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

A Randomised Controlled Multicenter Single-blinded Phase III Study to Evaluate the Efficacy and Safety of TISSEEL Lyo Compared to Manual Compression as an Adjunct to Haemostasis During Vascular Surgery

The primary objective of the study is to evaluate the efficacy of TISSEEL Lyo for haemostasis in patients receiving peripheral vascular prosthetic expanded polytetrafluoroethylene (ePTFE) conduits, as compared to a control arm treated with manual compression with surgical gauze pads.

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:

  1. Arterio-arterial-bypass;

     • Ilio-femoral bypass;
     • Femoro-femoral bypass;
     • Ilio-popliteal bypass;
     • Femoro-popliteal bypass;
     • Femoro-tibial vessel bypass

  2. 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.