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Prevention of deep vein thrombosis in patients with hip fractures: Low molecular weight heparin versus dextran

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Abstract

A randomized open trial was undertaken to compare the antithrombotic efficacy of a low molecular weight heparin (LMWH; Sandoparin®) with that of dextran 70 in patients undergoing surgery for hip fracture. One hundred thirteen patients received LMWH once daily subcutaneously at a fixed dosage while 103 patients received intravenous dextran 70. Postoperative deep vein thrombosis (DVT) was assessed by a diagnostic algorithm using the125Iodine fibrinogen uptake test as screening and Duplex ultrasonography and/or ascending venography as confirming techniques for suspected DVT. The frequency of DVT was significantly lower in the LMWH group than in the dextran group (15.5 versus 32.6%,p<0.005). Proximal DVT was rare in both groups (LMWH: 2%, Dextran: 1%). Only one case of fatal fat pulmonary embolism was observed during the 10 day prophylaxis period in a patient receiving Dextran. Three cases of pulmonary embolism occurred later; one fatal event in the dextran group on day 14, and two cases in the LMWH group (one fatal and one non-fatal event) on day 14 and 17, respectively. There was no major bleeding complication in either group. We conclude that the LMWH we used is safe, was well tolerated, and has a significantly better thromboprophylactic effect than dextran 70.

Résumé

Par un essai thérapeutique ouvert et randomisé, on a comparé l'efficacité antithrombotique de l'héparine à bas poids moléculaire (LMWH: Sandoparin) à celle de Dextran 70 chez des patients opérés d'une fracture du col de fémur. Cent treize patients ont reçu une dose unique de 36 mg de LMWH en sous-cutanée alors que 103 patients ont reçu 1500 ml de Dextran 70 par voie IV en trois injections. L'éventualité d'une thrombose profonde (TP) postopératoire a été évaluée par un algorythme diagnostique utilisantile fibrinogène marqué (à l'iode 125) comme examen de dépistage et l'examen échographie/Doppler ou la phlébographie ascendante pour confirmer le diagnostic. La fréquence de TP a été significativement plus basse chez les patients recevant la LMWH par rapport à ceux qui recevaient le Dextran (15.5% vs 32.6%, respectivement,p<0.005). La TP proximale a été rare dans les deux groupes (2% vs 1%, respectivement). Il n'y a eu qu'un seul cas fatal d'embolie graisseuse pulmonaire, observé dans le groupe recevant le Dextran. Il y a eu trois cas d'embolie pulmonaire plus tardifs: un cas mortel dans le groupe Dextran, 14 jours après l'opération et deux cas (un mortel et un non mortel) dans le groupe LMWH, respectivement 14 et 17 jours après. Il n'y a eu aucune complication hémorragique majeure dans les deux groupes. Nous concluous que la LMWH est sûre, bien tolérée et est plus efficace pour prévenir la TP que la Dextran.

Resumen

Se emprendió un ensayo clínico randomizado con el propósito de comparar la eficacia antitrombótica de una heparina de bajo peso molecular (HBPM; Sandoparina) con la del dextrán 70 en pacientes sometidos a cirugía por fractura de cadera. 113 pacientes recibieron HBPM una vez al día por vía subcutánea a una dosis fija, y 103 pacientes recibieron dextrán 70 por vía intravenosa. La presencia de trombosis venosa profunda postoperatoria (TVP) fue determinada mediante un algorritmo utilizando la capacitación fibrinogeno125I como prueba de tamizaje y ultrasonografía duplex Doppler y/o venografía ascendente como prueba de comprobación en los casos de sospecha de TVP. La fecuencia de TVP fue significativamente más baja en el grupo de HBPM que en el grupo de dextrán (15.5% versus 32.6%,p<0.005). La TVP proximal fue infrecuente en los dos grupos (HBPM: 2%, Dextrán: 1%). Sólo se observó un caso de embolismo pulmonar fatal en el curso de profiliaxis de 10 días en un paciente que recibió dextrán. Hubo tres casos tardíos de embolismo pulmonar: uno de carácter fatal en el grupo de dextrán en el día 14, y dos casos en el grupo de HBP (uno fatal y uno no fatal) en los días 14 y 17, respectivamente. No se presentaron complicaciones de sangrado en los dos grupos. Nuestra conclusión es que la HBPM que utilizamos es un agente seguro, que fue bien tolerado y que exhibió una acción tromboprofiláctica significativamente superior que el dextrán 70.

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Oertli, D., Hess, P., Dūrig, M. et al. Prevention of deep vein thrombosis in patients with hip fractures: Low molecular weight heparin versus dextran. World J. Surg. 16, 980–984 (1992). https://doi.org/10.1007/BF02067011

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