RE-NOVATE 2 trial

Related trials

Patients

patients undergoing total hip-replacement surgery

Inclusion criteria

patients scheduled to undergo primary, unilateral, elective total hip arthroplasty; male or female 18 years of age or older.

Exclusion criteria

patients weighing less than 40 kg; history of bleeding diathesis; patients who in the investigators judgement are perceived as having an excessive risk of bleeding, for example, constitutional or acquired coagulation disorders or because of anticipated need of quinidine, verapamil or other restricted medication during the treatment period; major surgery or trauma (e.g., hip fracture) within 3 months of enrolment; recent unstable cardiovascular disease (in the investigators opinion) such as uncontrolled hypertension, that is ongoing at the time of enrolment or history of myocardial infarction within 3 months of enrolment; any history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm. ongoing treatment for VTE; clinically relevant bleeding (gastrointestinal, pulmonary, intraocular or urogenital bleeding) within 6 months of enrolment; gastric or duodenal ulcer within one year of enrolment; liver disease expected to have any potential impact on survival (ie, hepatitis B or C, cirrhosis). This does not include Gilberts syndrome or hepatitis A with complete recovery; active liver disease or liver disease decreasing survival (e.g, acute hepatitis, chronic active hepatitis, cirrhosis) or ALT >3 x ULN; known severe renal insufficiency (CrCl <30 ml/min). Note: CrCl should be calculated only if serum creatinine is elevated or renal insufficiency is suspected; elevated creatinine that, in the investigators opinion, contraindicates venography; treatment with anticoagulants, clopidogrel, ticlopidine, abciximab, aspirin >162.5 mg/day or NSAID with t 1/2 >12 hours within 7 days prior to hip replacement surgery OR anticipated need while the patient is receiving study medication and prior to 24 hours after the last administration of any blinded study medication (COX-2 selective inhibitors are allowed); anticipated required use of intermittent pneumatic compression and electric stimulation of lower limb; pre-menopausal women (last menstruation within 1 year prior to signing informed consent) who are pregnant or are nursing. or are of child-bearing potential and are NOT practicing acceptable methods of birth control; known allergy to radio opaque contrast media; history of thrombocytopenia, including heparin-induced thrombocytopenia, or a platelet count <100,000 cells/microliter at randomisation; allergy to heparins or dabigatran etexilate; active malignant disease or current cytostatic treatment. Patients should be disease free for at least 5 years; leg amputee; known alcohol or drug abuse which would interfere with completion of the study; contraindications to enoxaparin;

Method and design

Randomized effectives

1010 / 1003 (studied vs. control)

Design

Parallel groups

Blinding

double-blind

Follow-up duration

28-35 days (mean 32d)

Number of centre

108

Hypothesis

Non inferiority

Primary endpoint

venous thromboembolism or death

RE-NOVATE 2 study, 0

Treatments

Patients

Method and design

Results

Reference(s)