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

Boehringer Ingelheim

Status: Terminated

Conditions: Arthroplasty, Replacement, Hip; Thromboembolism

Study type: Observational

Funder types: Industry

Identifiers

NCT00967447

1160.103

Details and patient eligibility

About

Open, prospective, uncontrolled, observational cohort study.

Enrollment: 2 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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