Recombinant hirudin, a new anticoagulant, has no effect on faecal blood loss

Br J Clin Pharmacol. 1992 May;33(5):524-6. doi: 10.1111/j.1365-2125.1992.tb04083.x.

Abstract

Hirudin is a selective thrombin inhibitor with strong anticoagulant properties which could elicit gastro-intestinal bleeding. A double-blind cross-over study of the effects of hirudin on gastro-intestinal bleeding was therefore conducted on 12 healthy, consenting males. After labelling erythrocytes with 51Cr and returning them intravenously, stools were collected for 2 days to measure radioactivity and hence baseline faecal blood loss. After injection of hirudin or placebo stools were collected for 3 days. Partial thromboplastin time was measured sequentially after medication with hirudin or placebo. This procedure was repeated after injection of the alternate medication 1 week later. Hirudin was tolerated well. Mean faecal blood loss associated with hirudin was slightly higher than with placebo (1.63 ml vs 1.15 ml over 3 days; 95% confidence interval for the difference between hirudin and placebo was -0.68 to 1.63) but these differences are clinically irrelevant. After hirudin injection PTT was elevated to about twice the baseline values but returned to baseline within 12 h after the last hirudin injection.

Publication types

  • Clinical Trial
  • Controlled Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Double-Blind Method
  • Gastrointestinal Hemorrhage / chemically induced
  • Hirudins / administration & dosage
  • Hirudins / adverse effects*
  • Humans
  • Male
  • Occult Blood*
  • Partial Thromboplastin Time
  • Thrombin / antagonists & inhibitors

Substances

  • Hirudins
  • Thrombin