Status:
UNKNOWN
Ketamine for Thrombolysis in Acute Ischemic Stroke
Lead Sponsor:
University Hospital, Caen
Collaborating Sponsors:
Société Française d'Anesthésie Réanimation
Fondation NRJ
Conditions:
Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
Brief 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 th...
Detailed Description
Rationale - Tissue-type plasminogen activator (tPA) is a double-sided molecule, with beneficial effect in acute ischemic stroke due to its intravascular fibrinolytic activity but with potential delete...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02258204
Start Date
March 1 2015
End Date
February 1 2018
Last Update
February 24 2016
Active Locations (1)
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1
CHU Caen
Caen, France