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Rivista di Angiologia

Official Journal of the International Union of Angiology, the International Union of Phlebology and the Central European Vascular Forum
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International Angiology 1999 June;18(2):122-6

lingua: Inglese

Com­par­i­son of 3,000 IU aXa of the low molec­u­lar ­weight hep­ar­in Cer­top­ar­in with 5,000 IU aXa in pre­ven­tion of deep vein throm­bo­sis after total hip replace­ment
Ger­man Throm­bo­sis Study Group

Adolf J., Frits­che H. M. *, Haas S. **, Hen­nig F. ***, Hor­bach T. ***, Kastl S. ***, Kop­pen­hag­en K. °, Michae­lis H. C. °°, Rha­man­za­deh R. °°°, Summa W. ***, Wag­ner W. ˆ,
Weber U. ˆˆ, Wolf H. °°

From the Depart­ment of Gen­er­al Sur­gery, City Hos­pi­tal, Mem­ming­en, Ger­ma­ny
* Depart­ment of Sur­gery, Dis­trict Hos­pi­tal, Gar­misch-Par­ten­kir­chen, Ger­ma­ny
** Depart­ment of Experi­men­tal Sur­gery, Uni­ver­sity Hos­pi­tal, ­Munich, Ger­ma­ny
*** Depart­ment of Sur­gery, Uni­ver­sity Hos­pi­tal, Erlan­gen, Ger­ma­ny
° Uni­ver­sity Clin­ic for Radiol­o­gy and Nucle­ar Med­i­cine, Ber­lin, Ger­ma­ny
°° Medical Depart­ment, NOVAR­TIS Phar­ma GmbH, Nurem­berg, Ger­ma­ny;
°°° Depart­ment of Sur­gery, Uni­ver­sity Hos­pi­tal, Ber­lin
ˆ Depart­ment of Sur­gery, City Hos­pi­tal, Bay­reuth, Ger­ma­ny;
ˆˆ Depart­ment of Ortho­paed­ics, Uni­ver­sity Hos­pi­tal, Ber­lin


Back­ground. The aim of this ran­dom­ized, dou­ble-blind and pros­pec­tive clin­i­cal trial was to inves­ti­gate wheth­er an ­increase of the con­ven­tion­al daily dos­age (3,000 IU aXa) of the low molec­u­lar ­weight hep­ar­in cer­top­ar­in up to 5,000 IU aXa/day might lower the inci­dence of deep vein throm­bo­sis (DVT) in ­patients under­go­ing elec­tive hip sur­gery.
Meth­ods. The main cri­te­ri­um of this trial was the inci­dence of DVT diag­nosed by bilat­er­al ascend­ing venog­ra­phy, which was per­formed ­either if DVT was clin­i­cal­ly sus­pect­ed or in each remain­ing ­patient ­between the 12th and the 14th post­op­er­a­tive day. A total num­ber of 172 ­patients were ­enrolled to ­receive the con­ven­tion­al dos­age of 3,000 IU aXa (Mono-Embol­ex NM®) and 169 ­patients to ­receive the high dos­age form (5,000 IU aXa) once daily. The mean age (±SD) was 69.6±9.5 and 67±11.7 years.
­Results. No rel­e­vant dif­fer­enc­es were found con­cern­ing pre­dip­os­ing risk fac­tors. The dura­tion of sur­gery was 93±25.2 and 88±21.4 min (mean±SD). Sur­gi­cal type and ­approach were not dif­fer­ent ­between the ­groups. Deep vein throm­bo­sis was detect­ed in 17 ­patients (9.9%) in the con­ven­tion­al dose group and in 16 ­patients (9.5%) in the high dose group (­intent-to-treat anal­y­sis; n.s.). The rate of bleed­ing com­pli­ca­tions was not sig­nif­i­cant­ly dif­fer­ent ­except the cell saver vol­umes (770±136 vs 475±186 ml; p<0.001). No sig­nif­i­cant dif­fer­ence was found in the seri­ous ­adverse event report­ing along the lines of EC-GCP (10 vs 8 ­events; p=0.65).
Con­clu­sions. This clin­i­cal trial con­firmed that the con­ven­tion­al dos­age (3,000 IU aXa/day) of cer­top­ar­in ­ensures max­i­mal anti­throm­bot­ic activ­ity.

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