Informations générales (source: ClinicalTrials.gov)
Effets de la kétamine en Association Avec le Rt-PA au Cours de l'Infarctus cérébral Aigu: étude Pilote contrôlée randomisée en Double Aveugle Avec critère de Jugement Radiologique (KETA)
Interventional
Phase 1/Phase 2
University Hospital, Caen (Voir sur ClinicalTrials)
mars 2015
février 2018
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Caen - Caen - France | Emmanuel Touzé, MD PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
- 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.
- 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.