Consent to thrombolysis in acute ischaemic stroke: from trial to practice.
Thrombolysis with intravenous alteplase for acute ischaemic stroke, which is already in clinical use in the USA and Canada, has recently been approved in the European Union. Until now, the use of alteplase has been limited to research or "off label" therapy in most of Europe. Despite the growing importance of this therapy and the many guidelines for use and comments on its effects, there is a lack of information about informed consent. The process of obtaining informed consent in the therapeutic decision process allows the patients to express their point of view on the risk-to-benefit ratio of thrombolytic therapy, on the different outcomes of stroke, and on the effect of thrombolysis. The discussion between the clinician and the patient or patient's family, during the process of obtaining consent to thrombolysis, can be problematic because therapy has to be given with extreme urgency. In this article, I highlight the importance of obtaining informed consent, help set out the process, and analyse the situations in which obtaining consent to thrombolysis may be legally and ethically avoided.
Ciccone
Alfonso
A
Stroke Unit, Department of Neurosciences, Niguarda Hospital, Milan, Italy. Alfonso.Ciccone@pmp.it
D002986:Clinical Trials as Topic; D005343:Fibrinolytic Agents / Q000627:therapeutic use*; D006801:Humans; D007258:Informed Consent; D020521:Stroke / Q000188:drug therapy*; D020458:Third-Party Consent; D015912:Thrombolytic Therapy / Q000379:methods*
D005343:Fibrinolytic Agents