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Thromb Haemost 1993; 70(04): 562-567
DOI: 10.1055/s-0038-1649627
Original Article
Clinical Studies
Schattauer GmbH Stuttgart

Orgaran (Org 10172) or Heparin for Preventing Venous Thrombosis after Elective Surgery for Malignant Disease? A Double-Blind, Randomised, Multicentre Comparison

A Gallus
1   The Flinders Medical Centre, Adelaide, Australia
,
J Cade
2   The Royal Melbourne Hospital and Austin Hospitals, Melbourne, Australia
,
P Ockelford
3   The Middlemore Hospital, Auckland, New Zealand
,
S Hepburn
4   The Oraganon Australia
,
M Maas
5   Medical Research and Development Unit, Organon International, Oss, The Netherlands
,
H Magnani
5   Medical Research and Development Unit, Organon International, Oss, The Netherlands
,
T Bucknall
2   The Royal Melbourne Hospital and Austin Hospitals, Melbourne, Australia
,
J Stevens
1   The Flinders Medical Centre, Adelaide, Australia
,
F Porteous
3   The Middlemore Hospital, Auckland, New Zealand
,
(ANZ-Organon Investigators’Group) › Author Affiliations
Further Information

Publication History

Received 18 January 1992

Accepted after revision 18 May 1993

Publication Date:
24 July 2018 (online)

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Summary

This double-blind, randomised, multicentre trial in 513 patients having elective surgery for intra-abdominal or intrathoracic malignancy compared the efficacy and safety of venous thrombosis (VT) prophylaxis using 750 anti-factor Xa units of Orgaran (a mixture of low molecular weight heparinoids) given subcutaneously (sc) twice-daily with that of twice-daily injections of 5,000 units Standard heparin. The main study endpoints were the development of postoperative VT detected by 125I-fibrinogen leg scanning, and the onset of clinically significant venous thromboembolism or bleeding. “Intent to treat” analysis showed a statistically non-significant trend towards less VT during Orgaran prophylaxis (10.4%) than after heparin (14.9%) and there was no difference in bleeding complications between the two study groups. Results remained similar if only patients who completed the intended course of therapy (“compliant patients”) were analysed. Other trials have shown that Orgaran prevents VT after hip surgery and stroke. We now show it is also safe and effective in patients having major surgery for cancer.

 

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