Trial (NCT00152971) assessed patients undergoing knee arthroplasty. To reflect > 자유게시판

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Trial (NCT00152971) assessed patients undergoing knee arthroplasty. To reflect PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/20460822 North American practice, PubMed ID:https://www.ncbi.nlm.nih.gov/pubmed/14960617 patients were randomized after surgery to 220 mg or 150 mg dabigatran etexilate once daily, or 30 mg subcutaneous enoxaparin twice daily. Patients received oral capsules and an injection in the morning, followed by a second injection in the evening.Rosencher et al. Thrombosis Journal 2012, 10:9 http://www.thrombosisjournal.com/content/10/1/Page 3 ofThe first injection was given 12?4 hours after surgery while dabigatran etexilate was initiated as a half dose 6?12 hours after surgery. Patients received treatment for 12?5 days and were to undergo bilateral venography (which was assessed centrally) within 12 hours of the last dose [7]. In each trial, an independent expert adjudication committee assessed the outcomes. The three trials were designed to be as similar as possible to enable the prospectively defined meta-analyses. Thromboprophylaxis could be continued after termination of the study at the discretion of the treating physician and all patients attended a follow-up visit 3 months after surgery. Concomitant treatment with aspirin at doses <160 mg and with selective cyclooxygenase-2 inhibitors was permitted, as was the use of elastic compression stockings; use of intermittent pneumatic compression devices was not permitted. In addition, the main exclusion criteria in all three trials excluded patients with a history of bleeding diatheses, a coagulation disorder, creatinine clearance <30 mL/min, or who had undergone 3 attempts to place spinal or epidural Methyl 5-amino-2,4-difluorobenzoate anaesthesia or in whom the placement was traumatic.Outcome measuresbleeding events (CRBE). All bleeding events were classified as described previously [5-7,13].Type of anaesthesiaIn these studies, general anaesthesia, spinal and/or epidural (neuraxial) anaesthesia and peripheral nerve block were used. For the post-hoc analyses, patients were classified as having received general or neuraxial anaesthesia or a combination; the combination was defined as general or neuraxial anaesthesia plus peripheral nerve block. The type of anaesthesia used was recorded in the electronic case record form. In patients who received neuraxial anaesthesia, the recommendation was not to initiate the first dose of oral therapy for a minimum of 2 hours after the catheter was removed. Trial medication was stopped if patients had an indwelling epidural catheter for pain relief postsurgery [5-7].StatisticsThe primary efficacy outcome in all trials was total VTE (symptomatic or venographic deep vein thrombosis [DVT], and/or symptomatic pulmonary embolism) and all-cause mortality, 3-(tert-Butyldimethylsilyloxy)propan-1-amine as agreed with the authorities during the planning process for the studies. However, this endpoint was not suitable for the post-hoc analysis due to the heterogeneity of the trials resulting from differences in the type of operation (hip versus knee arthroplasty), enoxaparin regimen used, timing of initiation of therapy and the duration of therapy. Hence the efficacy endpoint used in these pooled analyses was the composite of major VTE (venographic or symptomatic proximal DVT and/or pulmonary embolism) and VTE-related mortality during treatment. This was a secondary endpoint in the individual studies due to limitations regarding power and sample size. However, it was pre-specified for the meta-analyses, is more clinically relevant than total VTE and all-cause mortality, and is currently recommended by the European regulatory authorit.