Cerebrolysin in SAH (Subarachnoidal Haemorrhage) - Observational Study

Cerebrolysin in Patients Diagnosed With SAH - an Observational Cohort Study (PILOT)

Subarachnoid haemorrhage often affects people in middle age and is associated with high mortality or neurological damage. In recent years, advances in surgical techniques have im-proved the mortality rate. However, there is still need for the research for the optimal possible final effect of treatment. In our study, we've decided to examine the effect of a multimodal approach including Cerebrolysin in the supportive treatment of patients. We've examined the supply of neuroprotective drugs and neuromonitoring.

Study Overview

• Status: Completed
• Conditions: SAH (Subarachnoid Hemorrhage)

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Poland
  • Szczecin, Poland
    • Pomeranian Medical University, University Hospital no.1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population is the population of patients diagnosed with SAH, treated in University Hospital no.1 in Szczecin, Poland. Mainly the patients come from the population of westerpomeranian county, but as SAH is an acute disease also patients from the whole region of Poland, treated in the Hospital were included in the study.

Description

Inclusion Criteria:

• age >18 years old, diagnosis of SAH, treatment in ICU conditions

Exclusion Criteria:

• age <18 years, medical history of allergy to Cerebrolysin, acute renal failure, pregnancy, multi organ trauma, death within 48 hours after admission

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
A; Cerebrolysin administration
B; without Cerebrolysin administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GOS Glasgow Outcome Scale	Glasgow Outcome Scale - 5 points scale, characterizing the patients' deficits	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LOS Length of Stay	length of stay in days, that patient spent in hospital/ intensive care unit	hospitalisation time
mortality	mortality	1 month

Collaborators and Investigators

• Sponsor: Pomeranian Medical University Szczecin

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2021
• Primary Completion (Actual): October 15, 2022
• Study Completion (Actual): January 10, 2023

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 21, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: SAH; Cerebrolysin; neuromonitoring
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: SAH/2020/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No