From the Department of Neurology and MR Institute, Leopold Franzens
University Innsbruck (F.T.A.); Department of Neurology, Karl Franzens
University, Graz (F.Z.); Neurological Clinic, Maria Gugging (M.B.); Institute
of System Sciences, Johannes Kepler University (W.P.), Linz; 2nd Neurological
Clinic, Rosenhügel (B.M.), Vienna; and Department of Neurology, Alma
Mater Rudolfina, Vienna (K.Z.), Austria.
Correspondence to Franz T. Aichner, MD, Department of Neurology and Magnetic Resonance, University Hospital, Anichstraße 35, 6020 Innsbruck, Austria. E-mail mri-institut{at}uibk.ac.at
Background and Purpose—Experimental
studies suggest a beneficial effect of hemodilution on acute
ischemic stroke. This was not proven by previous multicenter
trials in the clinical setting. Various reasons have been suggested for
the failure of these studies, which we attempted to consider in the
Multicenter Austrian Hemodilution Stroke Trial (MAHST).
Methods—MAHST is a randomized, double-blind, placebo-controlled
study of hypervolemic hemodilution (HHD) within 6 hours of a clinically
first ischemic stroke localized in the middle cerebral artery
territory. The treatment consisted of 10% hydroxyethyl starch 200/0.5
(HES) and was tested against pure rehydration with Ringer's lactate
over a period of 5 days. Our primary outcome measure was clinical
improvement within 7 days as measured by the Graded Neurologic Scale
(GNS). We performed an adaptive interim analysis to reevaluate
the study goal after entering half of the projected number of
patients (n=200). At least 600 patients per group would have been
required for significant results, and therefore we decided to terminate
the trial.
Results—Ninety-eight patients received HHD and 102 patients
placebo. The baseline characteristics were comparable between both
groups. In the HHD group the absolute reduction of the hematocrit was
2.5% on day 2 with a maximum of 3.7% on day 5, which compares with a
reduction in the placebo group of 1% and 1.9%, respectively.
Intention-to-treat analysis showed no significant difference of
the change of the GNS scores between HHD-treated (median, -8.5; 95%
confidence interval, -14.2 to -4.0) and placebo-treated patients
(median, -6.0; 95% confidence interval, -11.0 to 0.0) on day 7, and
GNS scores remained similar in both treatment groups throughout the
trial. At 3 months, slightly more HHD patients showed complete
independence on the Barthel Index (28 versus 24), and fewer HHD than
placebo patients had died (13 versus 17), but these differences were
not statistically significant. HHD treatment was not associated with
any specific adverse event.
Conclusions—Mild HHD is safe but failed to demonstrate a
significant beneficial effect over the pure rehydration regimen in
patients with acute ischemic stroke.
© 1998 American Heart Association, Inc.
Original Contributions
Hypervolemic Hemodilution in Acute Ischemic Stroke
The Multicenter Austrian Hemodilution Stroke Trial (MAHST)
Key Words: clinical trials • hemodilution • hydroxyethyl starch • stroke, ischemic
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