Ketamine for Thrombolysis in Acute Ischemic Stroke

• Status: Unknown status
• Trial end date: 2018-02-01
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Caen
• Collaborators: Fondation NRJ; Société Française d'Anesthésie Réanimation
• Treatments: Ketamine

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.