Using a neuroprotective drug to treat patients who have a serious type of brain bleeding caused by a rupture of a weakened blood vessel (aneurysm)

ISRCTN ISRCTN16818128
DOI https://doi.org/10.1186/ISRCTN16818128
Submission date
28/06/2023
Registration date
10/07/2023
Last edited
07/07/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Aneurysmal subarachnoid hemorrhage (aSAH) is a very dangerous condition that can be life-threatening, even with prompt and intensive treatment. Around 15% of patients don't survive long enough to reach the hospital, and about 30% still die despite receiving the right treatment. For patients who have a more severe initial condition (measured using the Hunt Hess scale), this percentage can rise to 80%. Using neuroprotective drugs as an additional form of treatment has shown potential for improving the outcome in these cases.

Who can participate?
Adult patients with aneurysmal SAH and Hunt Hess grade 3 or more.

What does the study involve?
In addition to the standard treatment and monitoring, the study includes the use of a neuroprotective drug called Cerebrolysine as an additional therapy. The dosage prescribed is 30 ml per day for a duration of 10 days.

What are the possible benefits and risks of participating?
The potential benefit of this therapy is its neuroprotective effect, which can help reduce neuroinflammation and decrease the presence of harmful free radicals in the brain. The desired outcome is an improvement in functional recovery that exceeds expectations for this group of high-risk patients. As of now, there are no known risks associated with this therapy.

Where is the study run from?
University Hospital Zagreb, Department of Neurology (Croatia)

When is the study starting and how long is it expected to run for?
March 2021 to January 2025

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Prof Dr Zdravka Poljakovic, zdravka.po@gmail.com

Contact information

Prof Zdravka Poljakovic
Principal Investigator

Kispaticeva 12
Zagreb
10000
Croatia

ORCiD logoORCID ID 0000-0002-7216-6478
Phone +385 98237288
Email zpoljako@kbc-zagreb.hr

Study information

Study designSingle center observational longitudinal case-control study during a 90 day follow-up period
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet 43860 PIS.pdf
Scientific titleCerebrolysin as add-on therapy in patients with high Hunt-Hess grade subarachnoidal hemorrhage
Study acronymCERESAH
Study objectivesHypothesis:
Cerebrolysin as an add-on drug improves the 90-day functional outcome in patients with subarachnoidal haemorrhage and initial Hunt-Hess grade III and higher.
Aim of the study:
To investigate the efficacy and safety of Cerebrolysin as an add-on therapy in patients with HH grade III and higher.
Ethics approval(s)

Approved 14/06/2021, Ethics committee of University Hospital Zagreb (Kispaticeva 12, Zagreb, 10000, Croatia; +385-1-2388888; kbc-zagreb@kbc-zagreb.hr), ref: 8.1.-21/142-1

Health condition(s) or problem(s) studiedNeuroprotection in patients with severe aneurysmal subarachnoidal haemorhage after endovascular treatment of ruptured aneurysm
InterventionPatients with aneurysmal SAH and initial Hunt-Hess grade of 3 and more and secured aneurysm by endovascular approach will be included in the study and routinely treated during hospital stay. All patients will receive approved neuroprotective agent, Cerebrolysine (30 ml/day during 10 days) together with routine care. The diagnostic follow-up will be performed according to the routine protocol, and will include standard hemodynamic monitoring, TCD monitoring, ICP monitoring if required, EVD if required, intraventricular thrombolysis if required and routine neuroimaging. Patients will be then evaluated for their functional status 90 days after the bleeding. Functional outcome will be compared with literature data for the same group of patients with severe subarachnoidal bleeding.
Intervention typeDrug
Pharmaceutical study type(s)Not Applicable
PhasePhase IV
Drug / device / biological / vaccine name(s)Cerebrolysine
Primary outcome measureFunctional outcome of the patients measured with mRS 90 days after the bleeding
Secondary outcome measures1. Development of delayed neurological deficit during 21 days after the bleeding, verified by neuroimaging
2. Developement of the vasospasms during 14 days after the bleeding during TCD monitoring
3. Mortality after 90 days measured using patient records
4. Safety of Cerebrolysine (adverse events) up to end of study
Overall study start date01/03/2021
Completion date01/01/2025

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit70 Years
SexBoth
Target number of participants50
Key inclusion criteria1. Aneurysmal subarachnoidal haemorrhage
2. Inital Hunt-Hess grade 3 or higher
3. Endovasculary secured aneurysm
4. Availability to add-on treatment not more than 24 hours after embolisation
Key exclusion criteria1. Known allergy to Cerebrolysine
2. Refusal of participation in the study
Date of first enrolment01/09/2021
Date of final enrolment01/01/2024

Locations

Countries of recruitment

  • Croatia

Study participating centre

University Hospital Zagreb, Department of Neurology
Kispaticeva 12
Zagreb
10000
Croatia

Sponsor information

University Hospital Centre Zagreb
Hospital/treatment centre

Kispaticeva 12
Zagreb
10000
Croatia

Phone +385 98237288
Email kbc-zagreb@kbc-zagreb.hr
Website http://www.kbc-zagreb.hr/university_hospital_centre_zagreb_croatia
ROR logo "ROR" https://ror.org/00r9vb833

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date01/01/2026
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer reviewed journal.
Reports of preliminary results on international stroke congresses.
IPD sharing planThe datasets generated and analysed during the current study will be available upon request form to Zdravka Poljakovic, zdravka.po@gmail.com
The data which can be available are:
demographic data (blinded)
clinical data about the initial HH grade
clinical data about the aSAH treatment
Neuroimaging
TCD monitoring
safety data
early mRS -by discharge from the hospital
final mRS - 90 days after the initial bleeding
mortality data
relevant diagnostic work-up data if applicable (ICP, TCD, EVD; ivthrombolysis, etc)

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet in Croatian 07/07/2023 No Yes
Protocol file 07/07/2023 No No

Additional files

43860 protocol.pdf
43860 PIS.pdf
in Croatian

Editorial Notes

07/07/2023: Trial's existence confirmed by Ethics committee of University Hospital Zagreb