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

Primary Care Clinics

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency