A Prospective, Trial About Safety and Efficacy of Combined Treatment With Cerebrolysin in Acute Ischemic Hemispheric Stroke Patients Undergoing EndoVascular Treatment (EVT)
Acute Ischemic Stroke
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring STROKE, Endovascular Thrombectomy
Eligibility Criteria
Inclusion Criteria: Female or male inpatients. Age: ≥18 years. MRS ≤2 Clinical diagnosis of ischemic stroke eligible for EVT. No contraindication to undergo CT-Perfusion Patient is willing to participate voluntarily and to sign a written patient informed consent. Informed consent will be obtained from each patient or the legally authorised representative or two independent physicians, according to the regulatory and legal requirements of israel. Exclusion Criteria: Brain Imaging • Evidence of intracranial haemorrhage (ICH) on the CT-scan General Participation in another therapeutic clinical trial 3 months before baseline Female patient of childbearing age must not be pregnant as proved by Beta-HGB negative testing. Medical Platelet count of below 100x103/mm3 Blood glucose <50 Known haemorrhagic diathesis Manifest or recent severe or dangerous bleeding Known bacterial endocarditis, pericarditis Acute pancreatitis Documented ulcerative gastrointestinal disease during the last 3 months, oesophageal varices, arterial-aneurysm, arterial/venous malformation Neoplasm with increased bleeding risk Severe liver disease, including hepatic failure, cirrhosis, portal hypertension, oesaphageal varices) and active hepatitis Major surgery or significant trauma in past 3 months Multiple serious drug allergies Hypersensitivity or allergy to one of the components of the drug Severe renal impairment Psychiatric Chronic intoxication or chronic substance use disorder with pharmaceuticals, drugs, alcohol or industrial poisons Neurological Epilepsy Symptoms suggestive of subarachnoid haemorrhage, even if the CT-scan is normal Known history of or suspected intracranial haemorrhage Suspected subarachnoid haemorrhage or condition after subarachnoid hemorrhage from aneurysm Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) Haemorrhagic retinopathy, e.g. in diabetes (vision disturbances may indicate haemorrhagic retinopathy)
Sites / Locations
- Shaare Zedek Medical CenterRecruiting
Arms of the Study
Arm 1
Experimental
Participants undergo EVT plus Cerebrolysin
one group of patients should receive intravenous treatment with Cerebrolysin (30 ml/day) starting post EVT CT-Perfusion that will be performed not later than 3 hours from completion of EVT. Treatment will be continued for 10 consecutive days as one single daily infusion.