Extended Peri-operative Tinzaparin to Improve Disease-free Survival in Patients With Resectable Colorectal Cancer

Overall Survival

Death from any cause

Time frame: measured at 5 years

Venous Thromboembolism events

• VTE events defined as: a. Deep vein thrombosis: i. non-compressibility of any vein segment from the common femoral vein to the trifurcation of the popliteal vein on compressive ultrasonography ii.persistent intra-luminal filling defect of the iliac, common femoral, superficial femoral, popliteal, posterior tibial or peroneal veins on contrast venography b. Pulmonary embolism: i.high probability V/Q scan ii.positive pulmonary angiogram iii.spiral CT demonstrating intraluminal filling defect in a vessel larger than a segmental artery

Time frame: From randomization until 56 days post-surgery

Major surgical site bleeding events

• Major surgical site bleeding events defined as bleeding at the surgical site associated with: 1. requirement for ≥4 units of packed red blood cells 2. a drop in Hb of \>40 g/L during the first post-op week 3. bleeding requiring re-operation 4. fatal bleeding

Time frame: From randomization until 56 days post-surgery

Major bleeding events (not including the surgical site)

• Major bleeding events (not including the surgical site) defined as: 1. fatal bleeding, and/or 2. symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or, 3. bleeding causing a fall in hemoglobin level of ≥20 g/L, or leading to transfusion of ≥2 units of whole blood or red cells.

Time frame: From randomization until 56 days post-surgery

• Clinically relevant bleeding events prior to surgery and during the • Clinically relevant bleeding events

Clinically relevant bleeding events prior to surgery and during the follow-up period will be defined as overt bleeding episodes not meeting the inclusion for major bleeding but associated with one of the following: 1. medical intervention; 2. an unscheduled contact with a physician; 3. temporary cessation of anticoagulant treatment

Time frame: From randomization to 56 days post-surgery

Transfusion requirements

Transfusion requirements using the number of units transfused: 1. Red blood cells 2. Platelets (Adult dose) 3. Frozen Plasma

Time frame: From randomization to 56 days post-surgery

Correlative endpoints

The correlative endpoints seek to evaluate the pro-metastatic mechanisms of surgery and the antimetastatic mechanisms of LMWH in subjects undergoing surgical resection for colon cancer.

Time frame: 5 years

Other post-operative (day 0 - day 28) complications

Other post-operative (day 0 - day 28) complications as defined using the modified Clavien Classification

Time frame: Measured from Day 0 until day 28 post-operatively