Status:
UNKNOWN
A Prospective, Trial About Safety and Efficacy of Combined Treatment With Cerebrolysin in Acute Ischemic Hemispheric Stroke Patients Undergoing EndoVascular Treatment (EVT)
Lead Sponsor:
Shaare Zedek Medical Center
Conditions:
Acute Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is investigate the efficacy of a neuro/vascular-protective treatment with the drug Cerebrolysin in patients with acute ischemic stroke. starting immediately after compl...
Detailed Description
9.1. Overall Study Design and Plan-Description The study will be conducted as a single center, trial. In patients with AIS after EVT, according to the consensus guidelines, the study drug (Cerebrolys...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06070753
Start Date
October 1 2023
End Date
December 30 2024
Last Update
October 6 2023
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102