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Official Journal of the , the International Union of Phlebology and the
Indexed/Abstracted in: BIOSIS Previews, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 0,899
Online ISSN 1827-1839
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.