PMID- 18279190
OWN - NLM
STAT- MEDLINE
DCOM- 20080701
LR  - 20181201
IS  - 1365-3148 (Electronic)
IS  - 0958-7578 (Linking)
VI  - 18
IP  - 1
DP  - 2008 Feb
TI  - A randomized, single-blind, increasing dose safety trial of an oxygen-carrying 
      plasma expander (Hemospan) administered to orthopaedic surgery patients with 
      spinal anaesthesia.
PG  - 28-39
LID - 10.1111/j.1365-3148.2007.00811.x [doi]
AB  - 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.
FAU - Olofsson, C
AU  - Olofsson C
AD  - Department of Anaesthesiology, Karolinska University Hospital, Karolinska 
      Institutet, Stockholm, Sweden.
FAU - Nygards, E B
AU  - Nygards EB
FAU - Ponzer, S
AU  - Ponzer S
FAU - Fagrell, B
AU  - Fagrell B
FAU - Przybelski, R
AU  - Przybelski R
FAU - Keipert, P E
AU  - Keipert PE
FAU - Winslow, N
AU  - Winslow N
FAU - Winslow, R M
AU  - Winslow RM
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - England
TA  - Transfus Med
JT  - Transfusion medicine (Oxford, England)
JID - 9301182
RN  - 0 (Contrast Media)
RN  - 0 (Isotonic Solutions)
RN  - 0 (Plasma Substitutes)
RN  - 0 (Ringer's Lactate)
RN  - 4419T9MX03 (Iohexol)
SB  - IM
MH  - Adult
MH  - Aged
MH  - *Anesthesia, Spinal
MH  - Blood Pressure/drug effects
MH  - Cohort Studies
MH  - Contrast Media/administration & dosage/pharmacokinetics
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Humans
MH  - Iohexol/administration & dosage/pharmacokinetics
MH  - Isotonic Solutions/administration & dosage/adverse effects/pharmacokinetics
MH  - Male
MH  - Middle Aged
MH  - *Orthopedic Procedures
MH  - Plasma Substitutes/*administration & dosage/adverse effects/pharmacokinetics
MH  - Ringer's Lactate
MH  - Single-Blind Method
MH  - Time Factors
EDAT- 2008/02/19 09:00
MHDA- 2008/07/02 09:00
CRDT- 2008/02/19 09:00
PHST- 2008/02/19 09:00 [pubmed]
PHST- 2008/07/02 09:00 [medline]
PHST- 2008/02/19 09:00 [entrez]
AID - TME811 [pii]
AID - 10.1111/j.1365-3148.2007.00811.x [doi]
PST - ppublish
SO  - Transfus Med. 2008 Feb;18(1):28-39. doi: 10.1111/j.1365-3148.2007.00811.x.