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

A Gallus; J Cade; P Ockelford; S Hepburn; M Maas; H Magnani; T Bucknall; J Stevens; F Porteous; (ANZ-Organon Investigators’Group)

doi:10.1055/s-0038-1649627

Thrombosis and Haemostasis, Table of Contents

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

¹The Flinders Medical Centre, Adelaide, Australia

,

J Cade

²The Royal Melbourne Hospital and Austin Hospitals, Melbourne, Australia

,

P Ockelford

³The Middlemore Hospital, Auckland, New Zealand

,

S Hepburn

⁴The Oraganon Australia

,

M Maas

⁵Medical Research and Development Unit, Organon International, Oss, The Netherlands

,

H Magnani

⁵Medical Research and Development Unit, Organon International, Oss, The Netherlands

,

T Bucknall

²The Royal Melbourne Hospital and Austin Hospitals, Melbourne, Australia

,

J Stevens

¹The Flinders Medical Centre, Adelaide, Australia

,

F Porteous

³The Middlemore Hospital, Auckland, New Zealand

,

(ANZ-Organon Investigators’Group)

› Author Affiliations

Abstract

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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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References

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