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

NCT05124353 | Unknown Phase 2

• 1 other identifier: Neuroprotective 1/2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Stroke, Acute, Ischemic

Keywords

acute.stroke; ischemic stroke; neuroprotection; treatment

Outcome Measures

Primary Outcomes (16)

• Survival

  survival rate within first 6 months

  6 months

• NIHSS

  NIH Stroke Scale

  day 1

• NIHSS

  NIH Stroke Scale

  month 3

• NIHSS

  NIH Stroke Scale

  month 6

• Rankin

  modified Rankin Score

  day 1

• Rankin

  modified Rankin Score

  month 3

• Rankin

  modified Rankin Score

  month 6

• pre MRS

  modified pre Rankin Score

  day 1

• pre MRS

  modified pre Rankin Score

  month 3

• pre MRS

  modified pre Rankin Score

  month 6

• IQ code

  IQ code

  month 3

• IQ code

  IQ code

  month 6

• Geriatric Depression Scales

  Geriatric Depression Scales

  month 3

• Geriatric Depression Scales

  Geriatric Depression Scales

  month 6

• IV

  infarct volume of the control CT

  10 days

• modified treatment in cerebral infarction (mTICI score)

  measure the reperfusion grade post thrombectomy - radiological imaging

  1 month

Study Arms (2)

G1 : Treatment Group (TG)r

ACTIVE COMPARATOR

Patients in TG receive neuroprotective drug: standard dose of Cerebrolysin 30ml i.v. in the first 6 hours after first symptoms. After EVT the administration is continued for 10 days.

Drug: Cerebrolysin

G2 : Control Group (CG)

NO INTERVENTION

Patients in CG receive no additional i.v. treatment.

Interventions

Cerebrolysin DRUG

Cerebrolysin 30ml i.v., administrated in first 6 hours after stroke onset and fo 10 day afterwards in Neurology Department or ICU conditions.

Also known as: neuroprotective treatment

G1 : Treatment Group (TG)r

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• acute ischemic stroke diagnosis,
• qualification for mechanical thrombectomy, without previous thrombolysis
• age \>18

You may not qualify if:

• age \<18
• pregnancy
• cerebrolysin allergy
• epilepsy
• renal failure
• thrombolysis

Sponsors & Collaborators

• Pomeranian Medical University Szczecin: lead

Study Sites (1)

Pomeranian Medical University, University Hospital no.1

Szczecin, Poland

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

cerebrolysin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Konrad Jarosz

  Pomeranian Medical Univerisity

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Klaudyna Kojder

CONTACT

+48692581426; klaudynakojder@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 25, 2021
• First Posted: November 17, 2021
• Study Start: April 27, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)