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Updated: Feb 24, 2026
Optimized Management of Endovascular Treatment for Acute Ischemic Stroke
Published on: January 18, 2018
Effect of informed consent on patient characteristics in a stroke thrombolysis trial
Götz Thomalla1, Florent Boutitie2, Jochen B Fiebach2
1From Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum (G.T., C.H., B.C., C.G.), and Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Diagnostikzentrum (J.F.), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany; Service de Biostatistique (F.B., P.R.) and Department of Neurology (N.N., T.-H.C.), Hospices Civils de Lyon; Université Lyon 1 (F.B., P.R.), Villeurbanne; CNRS, UMR 5558 (F.B., P.R.), Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, Villeurbanne, France; Centrum für Schlaganfallforschung Berlin (CSB) (J.B.F., M. Ebinger, M. Endres) and Klinik und Hochschulambulanz für Neurologie (M. Ebinger, M. Endres), Charité-Universitätsmedizin Berlin, Germany; Department of Neurology (C.Z.S.), Aarhus University Hospital, Denmark; Department of Radiology (S.P., J.P.), Institut de Diagnostic per la Image (IDI), Hospital Dr Josep Trueta, Institut d'Investgació Biomèdica de Girona (IDIBGI), Girona, Spain; Department of Neurosciences, Experimental Neurology, and Leuven Research Institute for Neuroscience and Disease (LIND) (R.L.), KU Leuven-University of Leuven; VIB, Laboratory of Neurobiology (R.L.), Center for Brain & Disease Research, Leuven; Department of Neurology (R.L.), University Hospitals Leuven, Belgium; Institute of Neuroscience & Psychology (K.W.M.) and Robertson Centre for Biostatistics (I.F.), University of Glasgow, UK; Stroke Division (V.T.), Florey Institute of Neuroscience and Mental Health; and Department of Neurology (V.T.), Austin Health, Heidelberg, Australia. thomalla@uke.de.
Objective:
To determine whether the manner of consent, i.e., informed consent by patients themselves or informed consent by proxy, affects clinical characteristics of samples of acute stroke patients enrolled in clinical trials.
Methods:
We analyzed the manner of obtaining informed consent in the first 1,005 patients from WAKE-UP, an investigator-initiated, randomized, placebo-controlled trial of MRI-based thrombolysis in stroke patients with unknown time of symptom onset running in 6 European countries. Patients providing informed consent by themselves were compared with patients enrolled by proxy consent. Baseline clinical measures were compared between groups.
Results:
In 359 (35.7%) patients, informed consent was by proxy. Patients with proxy consent were older (median 71 vs 66 years, p < 0.0001) and had a higher frequency of arterial hypertension (58.2% vs 43.4%, p < 0.0001). They showed higher scores on the NIH Stroke Scale (median 11 vs 5, p < 0.0001) and more frequently aphasia (73.7% vs 20.0%, p < 0.0001). The rate of proxy consent varied among countries (p < 0.0001), ranging from 77.1% in Spain to 1.2% in Denmark.
Conclusions:
Patients recruited by proxy consent were older, had more severe strokes, and had higher prevalence of aphasia than those with capacity to give personal consent. Variations in the manner of consent across countries may influence trial results.
Clinicaltrialsgov And Clinicaltrialsregistereu Identifiers:
NCT01525290 (clinicaltrials.gov); 2011-005906-32 (clinicaltrialsregister.eu).
