Hydroxyethyl starch reduces coagulation competence and increases blood loss during major surgery: results from a randomized controlled trial

Ann Surg. 2014 Feb;259(2):249-54. doi: 10.1097/SLA.0000000000000267.

Abstract

Objective: This study evaluated whether administration of hydroxyethyl starch (HES) 130/0.4 affects coagulation competence and influences the perioperative blood loss.

Background: Artificial colloids substitute blood volume during surgery; with the administration of HES 130/0.4 (Voluven, Fresenius Kabi, Uppsala, Sweden) only a minor effect on coagulation competence is expected.

Methods: Eighty patients were scanned for enrollment in the study, and 40 patients fulfilled the inclusion criteria. Two patients withdrew their consent to participate in the study, and 5 patients were excluded. Thus, 16 patients were randomized to receive lactated Ringer's solution and 17 to receive HES 130/0.4.

Results: Among the patients receiving HES 130/0.4, thrombelastography indicated reduced clot strength (P < 0.001) and blinded evaluation of the perioperative blood loss was 2.2 (range 0.5 to 5.0) versus 1.4 (range 0.5 to 2.4) L in the patients who received HES 130/0.4 or lactated Ringer, respectively (P < 0.038). The patients in the lactated Ringer's group, however, received more fluid (P < 0.0001) than those in the HES 130/0.4 group. There was no significant difference between the 2 groups with regard to frequency of reoperations or the length of hospital stay, but use of HES 130/0.4 was both more expensive and less efficacious than the use of lactated Ringer.

Conclusions: Administration of HES 130/0.4 reduced clot strength and perioperative hemorrhage increased by more than 50%, while administration of lactated Ringer's solution provoked an approximately 2.5 times greater positive volume balance at the end of surgery.

Trial registration: ClinicalTrials.gov NCT01444508.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Blood Coagulation / drug effects*
  • Blood Coagulation Tests
  • Blood Loss, Surgical / prevention & control
  • Blood Loss, Surgical / statistics & numerical data*
  • Cost-Benefit Analysis
  • Cystectomy* / economics
  • Denmark
  • Double-Blind Method
  • Female
  • Hospital Costs / statistics & numerical data
  • Humans
  • Hydroxyethyl Starch Derivatives / adverse effects*
  • Hydroxyethyl Starch Derivatives / economics
  • Hydroxyethyl Starch Derivatives / therapeutic use
  • Hypovolemia / etiology
  • Hypovolemia / prevention & control*
  • Intraoperative Complications / blood
  • Intraoperative Complications / chemically induced
  • Intraoperative Complications / economics
  • Intraoperative Complications / prevention & control
  • Isotonic Solutions / adverse effects
  • Isotonic Solutions / economics
  • Isotonic Solutions / therapeutic use
  • Length of Stay / economics
  • Length of Stay / statistics & numerical data
  • Male
  • Middle Aged
  • Plasma Substitutes / adverse effects*
  • Plasma Substitutes / economics
  • Plasma Substitutes / therapeutic use
  • Postoperative Complications / blood
  • Postoperative Complications / economics
  • Postoperative Complications / epidemiology
  • Postoperative Complications / prevention & control
  • Prospective Studies
  • Ringer's Lactate
  • Treatment Outcome

Substances

  • HES 130-0.4
  • Hydroxyethyl Starch Derivatives
  • Isotonic Solutions
  • Plasma Substitutes
  • Ringer's Lactate

Associated data

  • ClinicalTrials.gov/NCT01444508