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Italian acute stroke study hemodilution (I.A.S.S.-H.) organisation and methodology

Article type: Other

Authors: Italian Acute Stroke Study Group, *; **

Correspondence: [**] Correspondence to: Livia Candelise, II Clinica Neurologica Via F. Sforza 35, 1-20122 Milano, Italy

Note: [*] Supported by: National Research Council of Italy, Special Project of Preventive Medicine, Subproject Arteriosclerosis

Note: [] Accepted by: Guest Editor H. Lechner

Keywords: acute stroke, clinical trial, hemodilution

DOI: 10.3233/CH-1986-6103

Journal: Clinical Hemorheology and Microcirculation, vol. 6, no. 1, pp. 11-16, 1986

Published: 9 December 2016
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Abstract

The Italian Acute Stroke Study Hemodilution (I.A.S.S.-H.) recruits 1,200 patients with recent (12 hrs) acute stroke admitted to university-hospital departments of neurology in Italy. The patients, randomized centrally by telephone, are allocated as follows: 50% to the treated group (hemodilution treatment) and 50% to the control group (standard treatment). Randomization is stratified by centers and severity of neurological deficit on admission.

Hemodilution treatment is performed by venesection and infusion of dextran 40; standard treatment will be provided by each Center within a common general regimen. At the end of six months the Clinical Coordination Center collects the follow-up data on mortality and disability by telephone. Hemodilution treatment will be considered of benefit if it reduces significantly mortality and disability risk, compared with the control group.

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