Mechanisms, predictors and clinical impact of early neurological deterioration: the protocol of the Trondheim early neurological deterioration study

摘要

Background: 10-40% of patients with acute ischemic stroke (AIS) suffer an early neurological deterioration (END),which may influence their long term prognosis. Multiple definitions of END exist, even in recently published papers.In the search for causes, various biochemical, clinical, and imaging markers have been found to be associated toEND after AIS in some but not in other studies.The primary aim of this study is to assess the contribution of END to functional level at 3 months post strokemeasured by modified Rankin Scale (mRS). Secondary aims are to identify factors and mechanisms associated withEND and to define the prevalence, degree and timing of END in relation to stroke onset, and to compareScandinavian Stroke Scale (SSS) and National Institute of Health Stroke Scale (NIHSS) based END-definitions.We hypothesized that END detected by changes in NIHSS and SSS (according to previously published criteria) at athreshold of 2 points indicate worsened prognosis, and that SSS is not inferior to NIHSS in predicting such achange. We further hypothesized that clinical deterioration has several causes, including impaired physiologicalhomeostasis, vascular pathology, local effects and reactions secondary to the ischemic lesion, along withbiochemical disturbances.Methods: Single-centre prospective observational study.Participants: Previously at home-dwelling patients admitted to our stroke unit within 24 hours after ictus of AIS areincluded into the study, and followed for 3 months. They are managed according to current procedures andnational guidelines. A total of 368 patients are included by the end of the enrolment period (December 31st 2013),and the material will be opened for analysis by June 30th 2014.Frequent neurological assessments, continuous monitoring, and repeated imaging and blood samples areperformed in all patients in order to test the hypotheses.Discussion: Strengths and weaknesses of our approach, along with reasons for the methods chosen in this studyare discussed.