Ketamine for Thrombolysis in Acute Ischemic Stroke
Status:
Unknown status
Trial end date:
2018-02-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University Hospital, Caen
Collaborators:
Fondation NRJ Société Française d'Anesthésie Réanimation