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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References
Lindblad, B.: Prophylaxis of postoperative thromboembolism with low dose heparin alone or in combination with dihydroergotamine: A review. Acta Chir. Scand. Suppl.543:31, 1988
Svend-Hansen, H., Bremerskov, V., Gotrik, J., Ostri, P.: Low-dose heparin in proximal femoral fractures: Failure to prevent deep-vein thrombosis. Acta Orthop. Scand.52:77, 1981
Bergqvist, D., Efsing, H.O., Hallböök, T., Hedlund, T.: Thromboembolism after elective and post-traumatic hip surgery: A controlled prophylactic trial with dextran 70 and low-dose heparin. Acta Chir. Scand.145:213, 1979
Fredin, H., Lindblad, B., Jaroszewski, H., Bergqvist, D.: Prevention of thrombosis after hip fracture surgery. Acta Chir. Scand. 681, 1985
Rorbaeck-Madsen, M., Jakobsen, B.W., Pedersen, J., Sorensen, B.: Dihydroergotamine and the thromboprophylactic effect of dextran 70 in emergency hip surgery. Br. J. Surg.75:364, 1988
Lahnborg, G.: Effect of low-dose heparin and dihydroergotamine on frequency of postoperative deep-vein thrombosis in patients undergoing post-traumatic hip surgery. Acta Chir. Scand.145:319, 1980
Moskovitz, P.A., Ellenberg, S.S., Feffer, H.L., Kenmore, P.I., Neviaser, R.J., Ruben, B.E., Varma, V.M.: Low-dose heparin for prevention of venous thromboembolism in total hip arthroplasty and surgical repair of hip fractures. J. Bone Joint Surg.60A:1065, 1978
Haas, S., Stemberger, A., Fritsche, H.M., Welzel, D., Wolf, H., Lechner, F., Bluemel, G.: Prophylaxis of deep-vein thrombosis in high risk patients undergoing total hip replacement with low molecular weight heparin plus dihydroergotamine. Drug. Res.37:839, 1987
Planes, A., Vochelle, N., Mazas, F., Mansat, C., Zucman, J., Landais, A., Pescariello, J.C., Weill, D., Butel, J.: Prevention of postoperative venous thrombosis: A randomized trial comparing unfractionated heparin with low molecular weight heparin in patients undergoing total hip replacement. Thromb. Haemost.60:407, 1988
Eriksson, B.I., Zachrisson, B.E., Teger-Nilsson, A.C., Risberg, B.: Thrombosis prophylaxis with low molecular weight heparin in total hip replacement. Br. J. Surg.75:1053, 1988
Levine, M.N., Hirsh, J., Gent, M., Turpie, A.G., Leclerc, J., Powers, P.J., Jay, R.M., Neemeh, J.: Prevention of deep vein thrombosis after elective hip surgery: A randomized trial comparing LMWH with standard unfractionated heparin. Ann. Intern. Med.114:545, 1991
Lassen, M.R., Borris, L.C., Christiansen, H.M., Moller-Larsen, F., Knudsen, V.E., Boris, P., Nehen, A.M., de Carvalho, A., Jurik, A.G., Nielsen, B.W., Lucht, U.: Heparin/dihydroergotamine for venous thrombosis prophylaxis: Comparison of low-dose heparin and low molecular weight heparin in hip surgery. Br. J. Surg.75:686, 1988
Gruber, U.F.: Prevention of fatal postoperative pulmonary embolism after prophylaxis with dextran 70 and low-dose heparin: An international multicenter study. Br. Med. J.:69, 1980
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. Trauma29:873, 1989
Lassen, M.R., Borris, L.C., Christiansen, H.M., Moller-Larsen, F., Knudsen, V.E., Boris, P., Nehen, A.M., Jurik, A.G., de Carvalho, A., Nielsen, B.W., Lucht, U.: Prevention of thromboembolism in hip-fracture patients. Arch. Orthop. Trauma Surg.108:10, 1989
Wille-Joergensen, P., Joergensen, L.N., Lassen, M.R., Borris, L.C., Hauch, O., Nehen, A.M., Kjaer, L., Jensen, R.: Phlebography as the golden standard in thromboprophylactic studies. Thromb. Haemost65(S):Abstract 1705, 1991
Büller, H.R., Lensing, A.W.A., Hirsh, J., ten Cate, J.W.: Deep vein thrombosis: New non-invasive diagnostic tests. Thromb. Haemost66:133, 1991
Wheeler, H.B., Anderson, F.A.: Diagnostic approaches for deep vein thrombosis. Chest89(Suppl.):407, 1986
Schindler, J.M., Kaiser, M., Gerber, A., Vuilliomenet, A., Popovic, A., Bertel, O.: Colour coded duplex sonography in suspected deep vein thrombosis of the leg. Br. Med. J.301:1369, 1990
Barsotti, J., Gruel, Y., Rosset, P., Favard, L., Dabo, B., Andreu, J., Delahousse, B., Leroy, J.: Comparative double-blind study of two dosage regimens of low molecular weight heparin in elderly patients with fracture of the neck of the femur. J. Orthop. Trauma4:371, 1990
Pini, M., Tagliaferri, A., Manotti, C., Lasagni, F., Rinaldi, E., Dettori, A.G.: Low molecular weight heparin compared with unfractionated heparin in prevention of deep-vein thrombosis after hip fractures. Int. Angiol.8:134, 1989
Bergqvist, D., Kettunen, K., Fredin, H., Fauno, P., Suomalainen, O.: Thromboprophylaxis in patients with hip fractures: A prospective, randomized comparative study between Org 10172 and dextran 70. Surgery109:617, 1991
Turpie, A.G., Levine, M.N., Hirsh, J., Carter, C.J., Jay, R.M., Powers, P.J., Andrew, M., Hull, R.D., Gent, M.: A randomized controlled trial of a low-molecular-weight-heparin (Enoxaparin) to prevent deep-vein thrombosis in patients undergoing elective hip surgery. N. Engl. J. Med.315:925, 1986
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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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DOI: https://doi.org/10.1007/BF02067011