Mobilization versus immobilization in the treatment of acute proximal deep venous thrombosis: a prospective, randomized, open, multicentre trial

• Published in: Current medical research and opinion 2006-03, Vol.22 (3), p.593-602
• Main Authors: Jünger, Michael, Diehm, Curt, Störiko, Helge, Hach-Wunderle, Viola, Heidrich, Heinz, Karasch, Thomas, Rudolf Ochs, Hermann, Ranft, Jürgen, Sannwald, Gerd A., Strölin, Anke, Janssen, Detlev
• Format: Article
• Language: English
• Subjects: Anticoagulants - therapeutic use; Bandages; Bed Rest; Dalteparin; Early Ambulation; Female; Humans; Low molecular weight heparin; Male; Middle Aged; Mobilization; Pain Measurement; Prospective Studies; Pulmonary Embolism - prevention & control; Statistics, Nonparametric; Treatment Outcome; Venous thrombosis; Venous Thrombosis - therapy
• ISSN: 0300-7995; 1473-4877
• DOI: 10.1185/030079906X89838

ABSTRACT Objective: The aim of prescribing strict bed rest for acute deep venous thrombosis is to reduce the risk of pulmonary embolism and pain in the legs, as well as swelling. This study was performed in order to compare outcome of mobilization against 5 days of strict bed rest in patients with acute proximal deep venous thrombosis (DVT). Methods: 103 in-patients with proximal DVT or patients admitted to the hospital because of proximal DVT were recruited to a randomized study. All patients were treated in hospital and given a lower leg and thigh compression bandage as well as therapeutic doses of the low molecular weight heparin, dalteparin-sodium (Fragmin*). *Fragmin is a trade name of Pfizer Inc., New York, USA Results: Seven of 52 patients (13.5%) in the mobile group versus 14 of 50 patients (28.0%) in the immobile group suffered at least one of the outcomes defined under the combined primary endpoint (clinically relevant pulmonary embolisms, pulmonary embolisms detectable by scintigraphy or computer tomography, progression of thrombosis or new thrombosis, nosocomial infections and/or serious adverse events) ( p = 0.088), whereby serious adverse events occurred once in the mobile group and three times in the immobile group. New pulmonary embolisms over the course were seen in 10 of 50 patients (20%) with a perfusion disorder at baseline scintigraphy, while such was ascertained only in one of 52 patients (1.9%) without a perfusion disorder at baseline scintigraphy. Leg pain was reduced from 54.1 (± 30.4) to 20.7 (± 19.2) in the mobilized group and from 41.0 (± 26.8) to 14.0 (± 11.1) in the immobilized patients. Leg pain was assessed using the visual analogue scale (0 = no pain, 100 = maximum pain). More immobilized patients complained of increasing back pain (23% versus 6%) and disturbed micturition (10% versus 2%) as well as defecation (13% versus 6%) on day 5. More patients in the mobile group reported increased stress from the thrombosis and its treatment (15% versus 6%). Conclusions: No benefit of prescribing bed rest in patients with deep venous thrombosis could be detected in this study. Based on data available, strict bed rest for at least 5 days is not justified if adequate therapy with low molecular weight heparin and adequate compression is assured. It remains open whether patients with initial signs of pulmonary embolism might profit from a brief immobilization.