Ketamine for Thrombolysis in Acute Ischemic Stroke
Sponsored by University Hospital, Caen
About This Study
KETA trial is a nonprofit, double-blind, randomized, controlled pilot trial with aiming to determine if co-administration of ketamine with recombinant of tissue type plasminogen activator (tPA) for thrombolysis in acute ischemic stroke compared with tPA co-administered with placebo, decreases cerebral infarction growth in diffusion weighted imaging between admission and day 1. Eligibility applies to patients with symptomatic ischemic stroke seen within 4.5 h of onset with middle cerebral artery or distal internal carotid artery occlusion, no contraindication to intravenous tPA-mediated thrombolysis and eligible to endovascular treatment of stroke (i.e. thrombectomy). The study has been designed to have 80% power to detect a 80% decrease of infarct volume growth in the tPA-ketamine group at a two-sided type I error rate of 5%. For this purpose, at least 25 patients per arm should be enrolled.
Conditions Studied
Interventions
- •Ketamine
- •Placebo
Eligibility
View full eligibility criteria
Inclusion Criteria: * Sudden focal neurological deficit attributable to acute ischemic stroke. * Age between 18 and 85. * Time from symptom onset less than 4.5 hours. * NIHSS score between 7 and 20. * Informed consent for participation. * Ketamine can be administered within 15 minutes after onset of tPA infusion. * MRI-based AIS diagnosis. * Middle cerebral (M1 or M2 segment) and/or distal internal carotid artery occlusion. * No intracranial hemorrhage on MRI. * Patient eligible for thrombectomy. Exclusion Criteria: * Contraindication to IV tPA treatment. * Contraindication to ketamine. * Contraindication to MRI. * Contraindication to intravascular iodinated contrast media. * Consciousness level \>1 on question 1a of NIHSS. * Pre-stroke mRS ≥3. * Concomitant medical illness that would interfere with outcome assessments and follow-up (e.g. advanced cancer or respiratory disease). * Previous participation in this trial or current participation in another investigational drug trial. * Infarct volume on diffusion weighted MRI more than 100 mL.