Open Trial of Intravenous Tissue Plasminogen Activator in Acute Carotid Territory Stroke

5,343

1,801

Background and Purpose-The authors present an overview of the current evidence and management recommendations for evaluation and treatment of adults with acute ischemic stroke. The intended audiences are prehospital care providers, physicians, allied health professionals, and hospital administrators responsible for the care of acute ischemic stroke patients within the first 48 hours from stroke onset. These guidelines supersede the prior 2007 guidelines and 2009 updates. Methods-Members of the writing committee were appointed by the American Stroke Association Stroke Council's Scientific Statement Oversight Committee, representing various areas of medical expertise. Strict adherence to the American Heart Association conflict of interest policy was maintained throughout the consensus process. Panel members were assigned topics relevant to their areas of expertise, reviewed the stroke literature with emphasis on publications since the prior guidelines, and drafted recommendations in accordance with the American Heart Association Stroke Council's Level of Evidence grading algorithm. Results-The goal of these guidelines is to limit the morbidity and mortality associated with stroke. The guidelines support the overarching concept of stroke systems of care and detail aspects of stroke care from patient recognition; emergency medical services activation, transport, and triage; through the initial hours in the emergency department and stroke unit. The guideline discusses early stroke evaluation and general medical care, as well as ischemic stroke, specific interventions such as reperfusion strategies, and general physiological optimization for cerebral resuscitation. The American Heart Association makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group are required to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest. Guidelines for the Early Management of PatientsThis statement was approved by the American Heart Association Science Advisory and Coordinating Committee on December 12, 2012. A copy of the document is available at http://my.americanheart.org/statements by selecting either the "By Topic" link or the "By Publication Date" link. To purchase additional reprints, call 843-216-2533 or e-mail kelle.ramsay@wolterskluwer.com.The Executive Summary is available as an online-only Data Supplement with this article at http://stroke.ahajournals.org/lookup/suppl/ doi:10.1161/STR.0b013e318284056a/-/DC1.The American Heart Association requests that this document be cited as follows: Jauch EC, Saver JL, Adams HP Jr, Bruno A, Connors JJ, Demaerschalk BM, Khatri P, McMullan PW Jr, Qureshi AI, Rosenfield K, Scott PA, Summers DR, Wang DZ, Wintermark M, Yonas H; on behalf of the American Heart Association Stroke Council, Council on Cardio...

Section: March 2013mentioning

confidence: 99%

Guidelines for the Early Management of Patients With Acute Ischemic Stroke

Jauch¹,

Saver²,

Adams³

et al. 2013

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1,801

“…15,16 Of the 360 variables of the files of the registry, 53 basic variables concerning clinical, etiological, radiological (baseline CT features), and biological data were selected for this study.…”

Section: Assessmentmentioning

confidence: 99%

“…In 2000, after a prospective study of coagulation parameters in the Lyon intravenous rt-PA trial, 15,16 we described a biological syndrome predictive of cerebral bleeding related to an early coagulopathy and characterized by an increase of fibrin(ogen) degradation products (FDP) 2 hours after the beginning of thrombolysis. 17 In the present study of 157 patients, we show that this early coagulopathy is exclusively predictive of early parenchymal hematomas (Ͻ24 hours) and is the major and single factor of their occurrence.…”

mentioning

confidence: 99%

Early Fibrinogen Degradation Coagulopathy Is Predictive of Parenchymal Hematomas in Cerebral rt-PA Thrombolysis

Trouillas

Derex

Philippeau

et al. 2004

Self Cite

Background-Little is known about the coagulation factors as predictors of cerebral bleeding in rt-PA thrombolysis. The aim of this study was to determine what early coagulation parameters could predict early hemorrhagic lesions. Methods-Consecutive patients were included in the Lyon rt-PA protocol. Early hematomas (within 24 hours), diagnosed on an anatomoradiological basis (symptomatic and not symptomatic) were considered for the study. Fibrinogen and fibrin(ogen) degradation products (FDP) were assessed at entry and at 2 and 24 hours after the beginning of thrombolysis.

“…"Reinfarct syndrome" was defined on the basis of a complete regression of motor and/or aphasic deficits followed by a recurrence of the neurological deficit in the same territory within 48 hours after onset, without evidence of hemorrhagic transformation. Outcome was classified into the following 4 categories according to the modified Rankin Scale (mRS): (1) "Good outcome" (mRS 0 -1) included patients with our original description of total recovery (6) and patients with mRS 1; (2) "moderate outcome" (mRS 2-3) corresponded to a presentation with objective neurological sequelae, but allowing walking, speech communication, and social life; (3) "poor outcome" (mRS 4 -5) corresponded to persistence of the neurological signs or to severe neurological sequelae, the patient being dependent for daily life; and (4) "death" corresponded to neurological death due to the infarct or hemorrhage. No other cause of death was observed.…”

Section: Outcome Assessmentmentioning

confidence: 99%

Thrombolysis With Intravenous rtPA in a Series of 100 Cases of Acute Carotid Territory Stroke

Trouillas

Nighoghossian

Derex

et al. 1998

Self Cite

102

Background and Purpose-Although new, large, double-blind, randomized studies are needed to establish the efficiency of intravenous thrombolysis, open trials of sufficient size may also provide novel data concerning specific outcomes after thrombolysis. Methods-An open study of intravenous rtPA in 100 patients with internal carotid artery (ICA) territory strokes between 20 and 81 years of age, with a baseline Scandinavian Stroke Scale (SSS) score of Ͻ48 at entry was conducted. Inclusion time was within 7 hours after stroke onset. rtPA (0.8 mg/kg) was infused for 90 minutes, with an initial 10% bolus. Heparin was given according to 3 consecutive protocols. The SSS evaluation was done on days 0, 1, 7, 30, and 90. CT scan was performed before treatment, on days 1 and 7. Etiological investigations included echocardiography and carotid Doppler sonography and/or angiography. Outcome at 1 year was documented by SSS score, the modified Rankin Scale (mRS) score, and a 10-point invalidity scale. Multivariate logistic regression was used to identify predictors of poor versus good outcome. Results-At day 90, 45 patients (45%) had a good result, defined as complete regression or slight neurological sequelae (mRS score of 0 -1), 18 patients had a moderate outcome (mRS 2-3), and 31 patients had serious neurological sequelae (mRS 4 -5). Six patients died, 2 with intracerebral hematoma after immediate heparin. Five of 11 patients (45.5%) treated between 6 and 7 hours had a good result. The overall intracerebral hematoma rate was 7%. Higher values of fibrin degradation products at 2 hours were observed in the subgroup with intracerebral hematomas. Significant predictors of poor outcome on multivariate logistic regression analysis were baseline SSS score of Ͻ15 (odds ratio [OR], 3.38; 95% confidence interval [CI], 1.07 to 10.74; Pϭ0.04), indistinction between white and gray matter on CT scan (OR, 6.59; 95% CI, 2.19 to 19.79; Pϭ0.0008), and proximal internal carotid thrombosis (OR, 3.29; 95% CI, 0.99 to 10.95; Pϭ0.05). Conclusions-Our study confirms the safety of intravenous rtPA at a dose of 0.8 mg/kg and suggests efficacy for this drug even within 7 hours. Outcome and hematoma rates were at least as favorable as for trials of therapy with a 3-hour time window. Subgroups with a poor prognosis include low baseline neurological score, baseline CT changes, and proximal ICA thrombosis. However, approximately 30% of patients with each of these characteristics show a good outcome, so their inclusion in future routine rtPA protocols is still justified. (Stroke. 1998;29:2529 -2540.)