A Prospective, Trial About Safety and Efficacy of Combined Treatment With Cerebrolysin in Acute Ischemic Hemispheric Stroke Patients Undergoing EndoVascular Treatment (EVT)

• Status: Recruiting
• Trial end date: 2024-12-30
• Target enrollment: 0
• Participant gender: All

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 completion of a EVT therapy.

The main question the study aims to answer is: If a 10 days treatment with the neuro/vascularprotective drug Cerebrolysin (30 ml/day as intravenous infusion) is able to increase the overall outcome of EVT therapy? Participants will receive intravenous treatment with Cerebrolysin (30 ml/day) starting immediately after thrombolytic therapy and being continued for 10 consecutive days as one single daily infusion. The modified Rankin Scale (mRS) 90 days after onset of symptoms will be investigated, but also the improvement in other ratings as well as the time course of the improvement.

In addition to the clinical outcome measures the study will assess neuroimaging perfusion CT-Perfusion parameters to evaluate possible direct improvement in microcirculation that might be an additional mechanism of action of cerebrolysin.

CT-Perfusion being done immediately after EVT will provide ability to stratify the data according to non-favorable CT-Perfusion parameters after EVT versus favoravle.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shaare Zedek Medical Center
• Treatments: Cerebrolysin

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)