PMID- 12097849
OWN - NLM
STAT- MEDLINE
DCOM- 20030630
LR  - 20171101
IS  - 1015-9770 (Print)
IS  - 1015-9770 (Linking)
VI  - 14
IP  - 1
DP  - 2002
TI  - Hydroxyethyl starch for hypervolemic hemodilution in patients with acute ischemic 
      stroke: a randomized, placebo-controlled phase II safety study.
PG  - 33-41
AB  - BACKGROUND: Hypervolemic hemodilution (HH) with hydroxyethyl starch (HES) 
      significantly increases cerebral blood flow and thus may reduce ischemic tissue 
      damage in the penumbra zones when given within the therapeutic time window. The 
      objective of this study was to investigate the safety of a 10% solution of HES 
      130/0.4 versus 0.9% saline solution in acute ischemic stroke by the incidence of 
      adverse events (AEs). METHODS: In a controlled, double-blind, randomized, 
      multicenter, phase II, parallel-group study, 106 patients with acute ischemic 
      stroke received high-dose HH with HES 130/0.4 or placebo within 6 h of symptom 
      onset with a randomization ratio of 2:1 in favor of HES therapy. RESULTS: There 
      were no significant differences between the groups with regard to the incidence 
      of the specific AEs (cardiovascular events, bleeding complications, allergic 
      reactions) assessed over days 1-30, or mortality over days 1-8. In addition, 
      global tests of efficacy showed a trend towards a better functional outcome with 
      HES therapy; however, the study was not designed to prove efficacy. CONCLUSIONS: 
      High-dose HH with HES or NaCl was generally safe and well tolerated. Safety 
      profiles were similar for the two treatment groups, and there was a 
      nonsignificant trend towards a better functional outcome with HES therapy.
CI  - Copyright 2002 S. Karger AG, Basel
FAU - Rudolf, J
AU  - Rudolf J
AD  - Klinik fur Neurologie der Universitat zu Koln, Koln, Deutschland. 
      jobst.rudolf@pet.min-koeln.mpg.de
CN  - HES in Acute Stroke Study Group
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - Switzerland
TA  - Cerebrovasc Dis
JT  - Cerebrovascular diseases (Basel, Switzerland)
JID - 9100851
RN  - 0 (Hydroxyethyl Starch Derivatives)
RN  - 0 (Placebos)
RN  - 0 (Saline Solution, Hypertonic)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Brain Ischemia/therapy
MH  - Female
MH  - *Hemodilution
MH  - Humans
MH  - Hydroxyethyl Starch Derivatives/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Placebos
MH  - Saline Solution, Hypertonic/therapeutic use
MH  - Stroke/*therapy
EDAT- 2002/07/05 10:00
MHDA- 2003/07/02 05:00
CRDT- 2002/07/05 10:00
PHST- 2002/07/05 10:00 [pubmed]
PHST- 2003/07/02 05:00 [medline]
PHST- 2002/07/05 10:00 [entrez]
AID - 63721 [pii]
AID - 10.1159/000063721 [doi]
PST - ppublish
SO  - Cerebrovasc Dis. 2002;14(1):33-41. doi: 10.1159/000063721.