MONREAL

Low-molecular-weight heparin vs. conventional low-dose heparin for the prevention of venous thromboembolism in patients with hip fracture (1989)

Condition

Prophylaxis for thromboembolic complications in patients admitted for surgery because of hip fracture

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Objective

To compare the efficacy of a LMWH with that of standard low-dose heparin in the prevention of VTE in patients with hip fracture

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Trial design

Prospective, randomized, double-blind study
Active treatment: LMWH (2165 LMWH, Kabi Vitrum AG) 2500 IU s.c. 2 hours before surgery, thereafter 5000 IU s.c. once daily for 9 days; heparin placebo s.c. twice daily (n=46)
Control treatment: UFH 5000 IU s.c. 2 hours before surgery, thereafter at 8-hours intervals for 9 days (n=44)

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Endpoints

Primary efficacy endpoint: DVT and PE during the postoperative period
Primary safety endpoints: bleeding, red cell transfusion requirement, hematocrit level

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Trial participants

90 consecutive patients (>40 years of age) who were admitted because of hip fracture and were operated on the day of fracture; 86 patients were evaluable

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Results

Efficacy outcome: 6 of 44 patients (13.6%) of the LMWH group developed postoperative PE, but none of the 42 patients in the UFH group; the difference was statistically significant. Indeterminate lung scans were detected in 8 patients (18.2%) assigned to LMWH and 6 patients (13.6%) given UFH. DVT occurred in significantly more patients given LMWH than in UFH-treated patients (31.8% vs. 14.3%). The rates for proximal vein thrombosis were 27.3% and 11.9%, respectively
Safety outcome: Intestinal bleeding complications occurred in 2 patients (4.5%) receiving LMWH and in 1 patient (2.4%) assigned to UFH. 2 patients in each group developed a wound hematoma (4.4% and 4.8%, respectively. Red cell transfusion requirements were larger in the LMWH group (40 units) than in the UFH group (20 units). The hematocrit levels on day 4 after surgery were similar in both groups. 2 patients in the LMWH group an 3 in the UFH group died (4.5% vs. 7.1%)

 

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Summary

Efficacy: In patients undergoing surgery because of hip fracture, low-dose standard heparin was more effective in preventing postoperative PE and DVT than a single daily injection of LMWH, in the dosage used
Safety: No significant difference was observed between both treatment groups in terms of bleeding, fall in postoperative hemoglobin, and the frequency of wound hematoma

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Reference

Monreal M, Lafoz E, Navarro A, Granero X, Caja V, Caceres E, Salvador R, Ruiz J. A prospective double-blind trial of a low molecular weight heparin once daily compared with conventional low-dose heparin three times daily to prevent pulmonary embolism and venous thrombosis in patients with hip fracture. J Trauma 1989;29:873-875

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Corresponding author

Prof. M. Monreal, Servicio de Medicina Interna, Hospital de Barcelona “Germans Trias i Pujol”, Ctra. Del Canyer s/n, Badalona (Barcelona), Spain

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