A randomized, single-blind, increasing dose safety trial of an oxygen-carrying plasma expander (Hemospan) administered to orthopaedic surgery patients with spinal anaesthesia

Transfus Med. 2008 Feb;18(1):28-39. doi: 10.1111/j.1365-3148.2007.00811.x.


The objective of this study was to further explore the safety of Hemospan (Sangart Inc., San Diego, CA, USA), an oxygen-carrying plasma expander. The aim of this study was to determine if Hemospan is well tolerated in orthopaedic surgery patients with spinal anaesthesia in doses up to 1 L. Hemospan was previously found to be well tolerated in normal volunteers and orthopaedic surgery patients with spinal anaesthesia in doses up to 500 mL. Five cohorts of six orthopaedic surgery patients, American Society of Anesthesiologists (ASA) I and II, were studied. In each cohort, four patients received Hemospan in doses ranging from 200 to 1000 mL, and two received Ringer's lactate immediately prior to induction of spinal anaesthesia. There were no serious adverse events (SAEs). Iohexol clearance measured before and 24 h after dosing was unaffected. There were 14 adverse events (AEs) in the 10 control patients (1.4 per patient) and 30 in the 20 patients receiving Hemospan (1.5 per patient). One patient in the group receiving 200 mL Hemospan had elevated mean arterial pressure after dosing, but there were no elevations in any of the other patients. The peak plasma Hemospan concentration in the 1000 mL group was 1.3 g dL(-1), with a dose-dependent clearance (T(1/2)) ranging from 14.1 to 23.0 h. Plasma methaemoglobin levels were independent of dose, reaching a maximum at 40 h after dosing and never exceeded 0.125 g dL(-1). Troponin T was transiently elevated in two patients receiving Hemospan without symptoms or electrocardiographic abnormalities or elevation of myocardial creatinine kinase isoenzyme. Hemospan was well tolerated in this group of patients at doses up to 1000 mL.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Anesthesia, Spinal*
  • Blood Pressure / drug effects
  • Cohort Studies
  • Contrast Media / administration & dosage
  • Contrast Media / pharmacokinetics
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Iohexol / administration & dosage
  • Iohexol / pharmacokinetics
  • Isotonic Solutions / administration & dosage
  • Isotonic Solutions / adverse effects
  • Isotonic Solutions / pharmacokinetics
  • Male
  • Middle Aged
  • Orthopedic Procedures*
  • Plasma Substitutes / administration & dosage*
  • Plasma Substitutes / adverse effects
  • Plasma Substitutes / pharmacokinetics
  • Ringer's Lactate
  • Single-Blind Method
  • Time Factors


  • Contrast Media
  • Isotonic Solutions
  • Plasma Substitutes
  • Ringer's Lactate
  • Iohexol