Thrombolysis for acute ischemic stroke: the problem of consent

被引:10
作者
Ciccone, A
Bonito, V
机构
[1] Hosp Niguarda Ca Granda, Dept Neurol Sci, I-20162 Milan, Italy
[2] Osped Riuniti Bergamo, Dept Neurol, I-24100 Bergamo, Italy
关键词
D O I
10.1007/s100720100062
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
The physician who decides to administer a thrombolytic therapy to a patient with acute stroke, has to consider both the results of randomized controlled trials, a complex matter itself, and problems related to consent, with its deontological and legal aspects, in the difficult contest of the emergency situations and acute stroke care. Although the analysis of studies on thrombolysis in medical literature has been ample and may be redundant, the latter aspect, i.e. that of how to cope with the problem of consent, has never been treated adequately. The problem of consent is particularly important and delicate in Italy and in most countries of the European Union, where thrombolytic therapy can be used only off label or within experimental studies. This document aims to provide the tools needed to overcome the gap between the generic indication for thrombolytic therapy in acute stroke, coming from clinical studies, and its effective use.
引用
收藏
页码:339 / 344
页数:6
相关论文
共 21 条
[1]   Acting without asking: An ethical analysis of the Food and Drug Administration waiver of informed consent for emergency research [J].
Adams, JG ;
Wegener, J .
ANNALS OF EMERGENCY MEDICINE, 1999, 33 (02) :218-223
[2]   Ethical considerations in clinical neuroscience - Current concepts in neuroclinical trials [J].
Alves, WA ;
Macciocchi, SN .
STROKE, 1996, 27 (10) :1903-1909
[3]  
Bogousslavsky J, 1996, CEREBROVASC DIS, V6, P315
[4]  
CANDELISE L, 1995, LANCET, V346, P1509
[5]   Thrombolysis for acute ischemic stroke: The patient's point of view [J].
Ciccone, A ;
Sterzi, R ;
Crespi, V ;
Defanti, CA ;
Pasetti, C .
CEREBROVASCULAR DISEASES, 2001, 12 (04) :335-340
[6]   PROACT: A phase II randomized trial of recombinant pro-urokinase by direct arterial delivery in acute middle cerebral artery stroke [J].
del Zoppo, GJ ;
Higashida, RT ;
Furlan, AJ ;
Pessin, MS ;
Rowley, HA ;
Gent, M .
STROKE, 1998, 29 (01) :4-11
[7]  
EMANUEL EJ, 1992, JAMA-J AM MED ASSOC, V267, P2067
[8]   Intra-arterial prourokinase for acute ischemic stroke - The PROACT II study: A randomized controlled trial [J].
Furlan, A ;
Higashida, R ;
Wechsler, L ;
Gent, M ;
Rowley, H ;
Kase, C ;
Pessin, M ;
Ahuja, A ;
Callahan, F ;
Clark, WM ;
Silver, F ;
Rivera, F .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1999, 282 (21) :2003-2011
[9]  
*IT MIN GRAC JUST, 1998, SER GEN, V105
[10]   RESEARCH IN EMERGENCY CARE WITHOUT CONSENT - NEW PROPOSED FDA RULES [J].
MARINER, WK .
LANCET, 1995, 346 (8989) :1505-1506