Low molecular weight heparin (KABI 2165) as thromboprophylaxis in elective visceral surgery. A randomized, double-blind study versus unfractionated heparin

Thromb Haemost. 1986 Dec 15;56(3):243-6.

Abstract

In two randomized double-blind studies perioperative bleeding complications and thromboembolic events were assessed in 189 patients (pts) undergoing elective visceral surgery after subcutaneous administration of a low molecular weight (LMW) heparin fragment (KABI fragment 2165) or unfractionated (UF) heparin. The first study comparing 1 X 7'500 anti-factor Xa IU LMW heparin daily with 2 X 5'000 IU UF heparin was interrupted because of excessive bleeding complications (LMW heparin: 11/23 pts, UF heparin: 2/20 pts, p less than 0.01). In the second study (146 pts) the dose of LMW heparin was reduced to 1 X 2'500 anti-factor Xa IU. Bleeding complications (LMW heparin: 14.9%, UF heparin: 15.3%) and thromboembolic events (LMW heparin: 2.86%, UF heparin: 2.94%) were equal among the two groups. 2'500 anti-factor Xa IU/day of this LMW heparin fragment, corresponding to 15 mg/day, is the lowest dose of a LMW heparin used in a randomized clinical trial and was found to be a safe and efficient regimen in perioperative thrombosis prophylaxis. An advantage of LMW heparin over UF heparin is its once daily administration.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Clinical Trials as Topic
  • Double-Blind Method
  • Factor X / antagonists & inhibitors
  • Factor Xa
  • Female
  • Hemorrhage / etiology
  • Heparin / administration & dosage
  • Heparin / pharmacology*
  • Heparin / therapeutic use
  • Humans
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Surgical Procedures, Operative*
  • Thromboembolism / prevention & control*

Substances

  • Factor X
  • Heparin
  • Factor Xa