Study to Evaluate the Safety and Efficacy of Pradaxar for the Prevention of Venous Thromboembolism in the Mexican Population Undergoing Elective Total Hip or Knee Replacement Surgery

Incidence of Symptomatic Venous Thromboembolic Events and Major Bleeding Events After Dabigatran Etexilate in Patients Subject to Subject to Elective Total Hip or Knee Replacement Surgery.

Open, prospective, uncontrolled, observational cohort study.

Inclusion criteria:

• patients age 18 years or above undergoing elective total hip or knee replacement surgery
• Written informed consent obtained for data collection and source data verification.

Exclusion criteria:

According to the approved label the following patients should not be treated with Pradaxar® 220mg q.d.:

• age of > 75 years
• renal impairment (creatinine clearance <50ml/min)
• patients on concomitant therapy with amiodarone or verapamil.
• elevated liver enzymes >2 upper limit of normal (ULN) and / or hepatic impairment or liver disease expected to have any impact on survival
• anaesthesia with post-operative indwelling epidural catheters
• hypersensitivity to dabigatran etexilate or to any of the excipients
• active clinically significant bleeding
• organic lesion at risk of bleeding
• spontaneous or pharmacological impairment of haemostasis except for the above-included patients groups
• concomitant treatment with quinidine