The rate of bleeding complications after pharmacologic deep venous thrombosis prophylaxis: a systematic review of 33 randomized controlled trials

Arch Surg. 2006 Aug;141(8):790-7; discussion 797-9. doi: 10.1001/archsurg.141.8.790.

Abstract

Hypothesis: Major bleeding complications from pharmacologic deep venous thrombosis (DVT) prophylaxis are infrequent.

Design: Systematic review of the MEDLINE database from 1965 to August 2005, using the terms DVT, prophylaxis, general surgery, and heparin.

Setting and patients: Randomized controlled trials evaluating pharmacologic DVT prophylaxis in patients undergoing general surgery.

Main outcome measures: Eight complication categories: injection site bruising, wound hematoma, drain site bleeding, hematuria, gastrointestinal tract bleeding, retroperitoneal bleeding, discontinuation of prophylaxis, and subsequent operation.

Results: Fifty-two randomized controlled trials studied DVT prophylaxis; 33 randomized controlled trials with 33 813 patients undergoing general surgery evaluated pharmacologic prophylaxis and quantified bleeding complications. Of the minor complications, injection site bruising (6.9%), wound hematoma (5.7%), drain site bleeding (2.0%), and hematuria (1.6%) were most common. Major bleeding complications, such as gastrointestinal tract (0.2%) or retroperitoneal (<0.1%) bleeding, were infrequent. Discontinuation of prophylaxis occurred in 2.0% of patients and subsequent operation in less than 1% of patients. When analyzed by high- vs low-dose unfractionated heparin, the lower dose had a smaller rate of discontinuation of prophylaxis (P = .02) and subsequent operation (P = .06).

Conclusions: Knowledge of bleeding complication rates is important for surgeons because DVT prophylaxis may soon be implemented by Medicare as a quality measure. This level 1 evidence report shows that bleeding complications requiring a change in care occur less than 3% of the time and seem reduced with lower-dose prophylaxis. Given these findings, most patients undergoing general surgery could receive pharmacologic prophylaxis safely.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review
  • Systematic Review

MeSH terms

  • Anticoagulants / adverse effects*
  • Anticoagulants / therapeutic use
  • Hemorrhage / chemically induced
  • Hemorrhage / epidemiology*
  • Humans
  • Incidence
  • Randomized Controlled Trials as Topic
  • Risk Factors
  • Venous Thrombosis / prevention & control*

Substances

  • Anticoagulants