Thromb Haemost 1989; 62(04): 1046-1049
DOI: 10.1055/s-0038-1647114
Original Article
Clinical Studies
Schattauer GmbH Stuttgart

A Double-Blind Randomized Placebo Controlled Trial of Thromboprophylaxis in Major Elective General Surgery Using Once Daily Injections of a Low Molecular Weight Heparin Fragment (Fragmin)

Paul A Ockelford
The Section of Haematology, Department of lmmunobiology, School of Medicine, University of Auckland, New Zealand
,
Janet Patterson
The Section of Haematology, Department of lmmunobiology, School of Medicine, University of Auckland, New Zealand
,
Allan S Johns
The Section of Haematology, Department of lmmunobiology, School of Medicine, University of Auckland, New Zealand
› Author Affiliations
Further Information

Publication History

Received 10 April 1989

Accepted after revision 22 August 1989

Publication Date:
24 July 2018 (online)

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Summary

The safety and efficacy of the low molecular weight heparin fragment (Fragmin) administered as a single daily injection of 2,500 anti Xa units has been evaluated in 183 patients undergoing major elective general surgery. The study was double-blinded and placebo controlled. The active agent, or placebo, was given subcutaneously with the preoperative medication and continued postoperatively for 5-9 days. Ninety five patients received Fragmin and 88 were randomized to receive the placebo. The clinical characteristics of the two treatment groups were similar. Fragmin significantly reduced the incidence of deep venous thrombosis, as detected by a positive 125I fibrinogen leg scan, relative to the placebo treated patients (4/95, 4.2%; v. 14/88, 15.9%; p = 0.008). The thrombotic events occurred predominantly (73%) amongst patients with malignancy. Haemorrhagic endpoints necessitating discontinuation of the trial treatment were 4% in each group. No severe adverse reactions or drug related deaths occurred. These results indicate that 2,500 anti Xa units of Fragmin given only once daily is effective thromboprophylaxis for patients undergoing major elective abdominal surgery.