Early Administration of Cerebrolysin on the Outcome of Patients With Acute Stroke Undergoing EVT
Status:
Recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
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