NCT06429943

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
Last Updated

May 28, 2024

Status Verified

December 1, 2023

Enrollment Period

1.7 years

First QC Date

May 21, 2024

Last Update Submit

May 21, 2024

Conditions

Keywords

SAHCerebrolysinneuromonitoring

Outcome Measures

Primary Outcomes (1)

  • GOS Glasgow Outcome Scale

    Glasgow Outcome Scale - 5 points scale, characterizing the patients' deficits

    1 month

Secondary Outcomes (2)

  • LOS Length of Stay

    hospitalisation time

  • mortality

    1 month

Study Arms (2)

A

Cerebrolysin administration

B

without Cerebrolysin administration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pomeranian Medical University, University Hospital no.1

Szczecin, Poland

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2024

First Posted

May 28, 2024

Study Start

January 15, 2021

Primary Completion

October 15, 2022

Study Completion

January 10, 2023

Last Updated

May 28, 2024

Record last verified: 2023-12

Locations