Early Administration of Cerebrolysin on the Outcome of Patients With Acute Stroke Undergoing EVT

• Status: Recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Background:

Stroke is the third major cause of death and disability worldwide. It was shown that combining early reperfusion therapy (thrombolysis and/or thrombectomy) with stroke unit care and immediate rehabilitation have beneficial effects on the patient recovery and outcomes. Cerebrolysin that was proven to have s neuroprotective and neurotrophic effects in vitro and in vivo, administered in combination with endovascular therapy (EVT) could have a positive impact on the prognosis and outcome of these patients.

Objectives:

To evaluate the impact of early administration of neuroprotective drug (Cerebrolysin) in patient undergoing EVT on the outcome of patients diagnosed with acute ischemic stroke.

Methods:

100 patients will be recruited to the proposed study according to the inclusion criteria:

Inclusion criteria:

Acute ischemic stroke patients NIHSS>8 Qualification for mechanical thrombectomy, without previous thrombolysis. The patients will be randomized into 2 subgroups: G1(standard dose of Cerebrolysin 30ml), - G2 (No Cerebrolysin).

The patients will be randomized into 2 subgroups: G1(standard dose of Cerebrolysin 30ml), - G2 (No Cerebrolysin). Cerebrolysin will be administered immediately after randomization or at the latest during the EVT procedure and will be continued for 10 days. After the EVT all patients, depending on their clinical condition, will be hospitalized in ICU (intensive care unit) or Neurology Department, where standard treatment and monitoring will be implemented, as well as standard rehabilitation. Outcome assessments will include: the NIH Stroke Scale, modified Rankin Score, pre MRS, IQ code, Geriatric Depression Scales, MoCA. Additionally, the infarct volume of the control CT will be measured. The follow up should be performed on day 7( or discharge), 1 month, 3 months, 6 months. The duration of the study is planned forr: 12 -24 months

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pomeranian Medical University Szczecin
• Treatments: Cerebrolysin

Criteria

Inclusion Criteria:

• acute ischemic stroke diagnosis,

• qualification for mechanical thrombectomy, without previous thrombolysis

• age >18

Exclusion Criteria:

• age <18

• pregnancy

• cerebrolysin allergy

• epilepsy

• renal failure

• thrombolysis