Extended-duration thromboprophylaxis in acutely ill medical patients with recent reduced mobility: Methodology for the EXCLAIM study
- 606 Downloads
Background: Venous thromboembolism (VTE) is a significant cause of mortality and morbidity in medical patients. Although thromboprophylaxis with enoxaparin reduces the risk of VTE in these patients, the optimal duration of therapy is not currently known. The EXCLAIM (EXtended CLinical prophylaxis in Acutely Ill Medical patients) study is designed to compare the efficacy and safety of extended-duration thromboprophylaxis using enoxaparin with the standard regimen of enoxaparin in acutely ill medical patients with recent reduced mobility.
Methods: All enrolled acutely ill medical patients receive enoxaparin 40 mg subcutaneously once daily for 10 ± 4 days. Eligible patients are then randomized in a blinded manner to receive either extended-duration thromboprophylaxis with enoxaparin 40 mg subcutaneously once daily or placebo subcutaneously once daily for an additional 28 ± 4 days. The primary efficacy endpoint is the incidence of VTE during the 28 ± 4 days after randomization. This study utilizes a standardized bilateral compression ultrasonography examination protocol that consists of an intensive interrogation of the deep veins of the lower extremities for proximal deep-vein thrombosis. The secondary efficacy endpoints are the rate of symptomatic VTE during the 3 months after randomization and mortality at 3 and 6 months after enrollment. The primary safety endpoint is the incidence of major hemorrhagic complications during the 28 ± 4 days after randomization.
Results: To date, 3,983 patients, with a broad range of medical conditions, have been included in the study. Almost one third of the enrolled patients with reduced mobility are acutely ill due to respiratory insufficiency and one third have infectious diseases.
Conclusions: The EXCLAIM study is designed to show the efficacy and safety of extended-duration thromboprophylaxis using enoxaparin in acutely ill medical patients with recent reduced mobility, which may potentially lead to a reduction in the incidence of late VTE events in these patients.
The EXCLAIM (EXtended CLinical prophylaxis in Acutely Ill Medical patients) study, involving 4,726 acutely ill medical patients with recent reduced mobility, is designed to compare the efficacy and safety of extended-duration thromboprophylaxis using 40 mg once daily enoxaparin (38 ± 4 days) with the standard regimen for enoxaparin (40 mg once daily for 10 ± 4 days). The objective of this study is to demonstrate that the extended-duration enoxaparin regimen is an effective and safe thromboprophylaxis regimen out of hospital.
KeywordsMedical patients Low-molecular-weight heparin Prophylaxis Venous thromboembolism
Unable to display preview. Download preview PDF.
- 1.Geerts WH, Pineo GF, Heit JA, et al (2004) Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 126(3 Suppl):338S–400SGoogle Scholar
- 5.Sandler DA, Martin JF (1989) Autopsy proven pulmonary embolism in hospital patients: Are we detecting enough deep vein thrombosis? J R Soc Med 82:203–205Google Scholar
- 6.Cohen AT, Edmondson RA, Phillips MJ, Ward VP, Kakkar VV (1996) The changing pattern of venous thromboembolic disease. Haemostasis 26:65–71Google Scholar
- 15.Writing Group for the Women’s Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women’s Health Initiative randomized controlled trial. JAMA 2002;288:321–333.Google Scholar
- 24.Cohen AT, Davidson BL, Gallus AS, et al (2003) Fondaparinux for the prevention of VTE in acutely ill medical patients [abstract]. Blood 102:15a [Abstract number 42]Google Scholar
- 25.Tapson VF, Decousus H, Piovella F, et al (2003) for the IMPROVE investigators. A multinational observational cohort study in acutely ill medical patients of practices in prevention of venous thromboembolism: findings of the International Medical Prevention Registry on Venous Thromboembolism (IMPROVE) [abstract]. Blood 102:321a [Abstract number 1154]Google Scholar
- 27.Eikelboom JW, Quinlan DJ, Douketis JD (1999) Extended-duration prophylaxis against venous thromboembolism after total hip or knee replacement: a meta-analysis of the randomised trials. Lancet 2001;358:9–15Google Scholar
- 30.Moher D, Schulz KF, Altman DG (2001) CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med 134:657–662Google Scholar
- 31.Ioannidis JP, Evans SJ, Gøtzsche PC, et al (2004) CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med 141:781–788Google Scholar
- 35.Kleber FX, Witt C, Vogel G, Koppenhagen K, Schomaker U, Flosbach CW (2003) THE-PRINCE study group. A randomized comparison of enoxaparin with unfractionated heparin for the prevention of venous thromboembolism in medical patients with heart failure or severe respiratory disease. Am Heart J 145:614–621PubMedCrossRefGoogle Scholar