Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery

Launched by BOEHRINGER INGELHEIM · Sep 12, 2005

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• • Inclusion criteria
• Inclusion criteria (selected):
• • Patients (18 years or older) scheduled to undergo a primary, unilateral, elective total hip replacement
• • Written Informed Consent
• • Exclusion criteria
• Exclusion criteria (selected):
• • Patients with an excessive risk of bleeding, for example because of history of bleeding diathesis major surgery or trauma within the last 3 months history of haemorrhagic stroke or any of the following intracranial pathologies: bleeding, neoplasm, AV malformation or aneurysm clinically relevant bleeding or gastric / duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days prior to joint replacement surgery or anticipated need during the study treatment period thrombocytopenia.
• • Active malignant disease or current cytostatic treatment
• • Known severe renal insufficiency
• • Liver disease expected to have any potential impact on survival, or elevated AST or ALT \> 2x upper limit of normal
• • Recent unstable cardiovascular disease or history of myocardial infarction within the last 3 months
• • Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential and are not practising or do not plan to continue practising acceptable methods of birth control
• • Allergy to radio opaque contrast media or iodine, heparins (incl. heparin induced thrombocytopenia) or dabigatran
• • Contraindications to enoxaparin
• • Participation in a clinical trial during the last 30 days