Extended-duration venous thromboembolism prophylaxis in acutely ill medical patients with recently reduced mobility: a randomized trial.
BACKGROUND: Extended-duration low-molecular-weight heparin has been shown to prevent venous thromboembolism (VTE) in high-risk surgical patients. OBJECTIVE: To evaluate the efficacy and safety of extended-duration enoxaparin thromboprophylaxis in acutely ill medical patients. DESIGN: Randomized, par...
| Publicado en: | Annals of Internal Medicine Vol. 153; no. 1; pp. 8 - 19 |
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| Autores principales: | , , , , , , , , |
| Formato: | clinical trial research Journal Article |
| Publicado: |
American College of Physicians
7/6/2010
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=105098052&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 105098052 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 00034819 AIM jtl: Annals of Internal Medicine issn: 00034819 maglogo: N pubinfo: dt: 7/6/2010 vid: 153 iid: 1 pid: 1652 pub: American College of Physicians place: Philadelphia, Pennsylvania artinfo: ui: 105098052 105098052 2010776238 10.7326/0003-4819-153-1-201007060-00004 NLM20621900 105098052 ppf: 8 ppct: 11 formats: tig: atl: Extended-duration venous thromboembolism prophylaxis in acutely ill medical patients with recently reduced mobility: a randomized trial. aug: au: Hull RD Schellong SM Tapson VF Monreal M Samama MM Nicol P Vicaut E Turpie AG Yusen RD affil: ThrombosisResearch Unit, University of Calgary, Foothills Hospital, Calgary, Alberta, Canada. rdhull@ucalgary.ca sug: subj: Anticoagulants Administration and Dosage Heparin, Low-Molecular-Weight Administration and Dosage Hospitalization Immobilization Adverse Effects Venous Thromboembolism Prevention and Control Acute Disease Adult Aged Aged, 80 and Over Anticoagulants Adverse Effects Delayed-Action Preparations Double-Blind Studies Drug Administration Schedule Heparin, Low-Molecular-Weight Adverse Effects Female Hemorrhage Chemically Induced Human Incidence Male Middle Age Risk Factors Treatment Outcomes Venous Thromboembolism Epidemiology Adult: 19-44 years Aged: 65+ years Aged, 80 & over Middle Aged: 45-64 years Female Male ab: BACKGROUND: Extended-duration low-molecular-weight heparin has been shown to prevent venous thromboembolism (VTE) in high-risk surgical patients. OBJECTIVE: To evaluate the efficacy and safety of extended-duration enoxaparin thromboprophylaxis in acutely ill medical patients. DESIGN: Randomized, parallel, placebo-controlled trial. Randomization was computer-generated. Allocation was centralized. Patients, caregivers, and outcome assessors were blinded to group assignment. (ClinicalTrials.gov registration number: NCT00077753) SETTING: 370 sites in 20 countries across North and South America, Europe, and Asia. PATIENTS: Acutely ill medical patients 40 years or older with recently reduced mobility (bed rest or sedentary without [level 1] or with [level 2] bathroom privileges). Eligibility criteria for patients with level 2 immobility were amended to include only those who had additional VTE risk factors (age >75 years, history of VTE, or active or previous cancer) after interim analyses suggested lower-than-expected VTE rates. INTERVENTION: Enoxaparin, 40 mg/d subcutaneously (2975 patients), or placebo (2988 patients), for 28 +/- 4 days after receiving open-label enoxaparin for an initial 10 +/- 4 days. MEASUREMENTS: Incidence of VTE up to day 28 and of major bleeding events up to 48 hours after the last study treatment dose. RESULTs: Extended-duration enoxaparin reduced VTE incidence compared with placebo (2.5% vs. 4%; absolute risk difference favoring enoxaparin, -1.53% [95.8% CI, -2.54% to -0.52%]). Enoxaparin increased major bleeding events (0.8% vs. 0.3%; absolute risk difference favoring placebo, 0.51% [95% CI, 0.12% to 0.89%]). The benefits of extended-duration enoxaparin seemed to be restricted to women, patients older than 75 years, and those with level 1 immobility. LIMITATION: Estimates of efficacy and safety for the overall trial population are difficult to interpret because of the change in eligibility criteria during the trial. CONCLUSION: Use of extended-duration enoxaparin reduces VTE more than it increases major bleeding events in acutely ill medical patients with level 1 immobility, those older than 75 years, and women. PRIMARY FUNDING SOURCE: Sanofi-aventis. pubtype: Academic Journal doctype: clinical trial research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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