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January 1, 1993Thrombosis and Haemostasis

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

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Why the study?

Does low molecular weight heparinoids (Orgaran) reduce venous thrombosis compared to standard heparin in patients having elective surgery for intra-abdominal or intrathoracic malignancy?

Population

513 patients having elective surgery for intra-abdominal or intrathoracic malignancy

Comparison

Low molecular weight heparinoids 750 anti-factor… vs Standard heparin 5,000 units subcutaneously…

Design

RCT, randomised, double-blind

Authors

AGAlexander GallusSouth Australia PathologyJCJ. F. CadeThe University of MelbournePOPaul OckelfordAuckland City Hospital

Discussion

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Implication

Does not support preferring Orgaran over heparin for venous thrombosis prevention in cancer surgery; leaves open a possible benefit for larger trials.

Key Points

  • To compare the safety and efficacy of subcutaneous Orgaran with standard heparin in preventing postoperative venous thrombosis in patients undergoing elective cancer surgery.
  • Conducted a double-blind, randomised, multicentre trial in 513 patients undergoing elective surgery for intra-abdominal or intrathoracic malignancy.
  • Assigned patients to subcutaneous twice-daily doses of either 750 anti-factor Xa units of Orgaran or 5,000 units of standard heparin.
  • Assessed postoperative venous thrombosis using 125I-fibrinogen leg scanning, alongside clinical surveillance for thromboembolism and bleeding events.
  • Intention-to-treat analysis demonstrated a statistically non-significant trend toward fewer venous thrombosis events with Orgaran (10.4%) compared to standard heparin (14.9%).
  • Observed no difference in bleeding complications between the two treatment groups, with consistent outcomes in compliant patient analyses.

Structured PICO

Does low molecular weight heparinoids (Orgaran) reduce venous thrombosis compared to standard heparin in patients having elective surgery for intra-abdominal or intrathoracic malignancy?

P
Population
513 patients having elective surgery for intra-abdominal or intrathoracic malignancy
I
Intervention
Low molecular weight heparinoids (Orgaran) 750 anti-factor Xa units subcutaneously twice-daily
C
Comparator
Standard heparin 5,000 units subcutaneously twice-daily
O
Outcome
Development of postoperative venous thrombosis detected by 125I-fibrinogen leg scanning, and the onset of clinically significant venous thromboembolism or bleedingcomposite

Low molecular weight heparinoids (Orgaran) showed a non-significant trend toward lower venous thrombosis rates compared to standard heparin without increasing bleeding in patients undergoing major cancer surgery.

Cite This Study

Gallus et al. (1993) studied this question.

synapsesocial.com/papers/6a88564ff6c5aff6584fd24ahttps://doi.org/10.1055/s-0038-1649627

Topics

Pulmonary embolismAnticoagulation in AF
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Low molecular weight heparin compared with unfractionated heparin in prevention of postoperative thrombosis1988 · 146 citations
  2. 2Low molecular weight heparin given the evening before surgery compared with conventional low-dose heparin in prevention of thrombosis1988 · 134 citations
  3. 3Reduction in Fatal Pulmonary Embolism and Venous Thrombosis by Perioperative Administration of Subcutaneous Heparin1988 · 1,319 citations
  4. 4Controlled trial of low-dose heparin and sulfinpyrazone to prevent venous thromboembolism after operation on the hip.1978 · 57 citations
  5. 5Prevention of Deep Vein Thrombosis following Total Hip Replacement by Low Molecular Weight Heparinoid1992 · 125 citations