SAH (Subarachnoid Hemorrhage)NCT06429943
Cerebrolysin in SAH (Subarachnoidal Haemorrhage) - Observational Study
An observational study of SAH (Subarachnoid Hemorrhage), run by Pomeranian Medical University Szczecin at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SAH (Subarachnoid Hemorrhage)
- How many people
- 47 participants
- Where
- 1 sitePoland
- Study dates
- 15 Jan 2021to 10 Jan 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- age >18 years old, diagnosis of SAH, treatment in ICU conditions
Who cannot join
- age <18 years, medical history of allergy to Cerebrolysin, acute renal failure, pregnancy, multi organ trauma, death within 48 hours after admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- SAH (Subarachnoid Hemorrhage)
- Keywords
- SAH, Cerebrolysin, neuromonitoring
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | Cerebrolysin administration | |
| B | without Cerebrolysin administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
GOS Glasgow Outcome Scale
Glasgow Outcome Scale - 5 points scale, characterizing the patients' deficits
Measured: 1 month
Secondary outcomes (2)
LOS Length of Stay
length of stay in days, that patient spent in hospital/ intensive care unit
Measured: hospitalisation time
mortality
mortality
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start15 Jan 2021
- Primary completion15 Oct 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SAH (Subarachnoid Hemorrhage)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 47 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429943
- Sponsor's protocol ID
- SAH/2020/2023
- Status last verified
- Dec 2023
- First submitted
- 21 May 2024
- Last updated
- 28 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebrolysin in Patients Diagnosed With SAH - an Observational Cohort Study (PILOT)
- ClinicalTrials.gov ID
- NCT06429943
- Acronym / sponsor ID
- SAH/2020/2023
- Conditions
- SAH (Subarachnoid Hemorrhage)
- Keywords
- SAH, Cerebrolysin, neuromonitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 28 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Cerebrolysin administration |
| B | – | –without Cerebrolysin administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- age >18 years old, diagnosis of SAH, treatment in ICU conditions
Key exclusion criteria (1 listed)
- age <18 years, medical history of allergy to Cerebrolysin, acute renal failure, pregnancy, multi organ trauma, death within 48 hours after admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
GOS Glasgow Outcome Scale
Time frame: 1 month
Glasgow Outcome Scale - 5 points scale, characterizing the patients' deficits
2 secondary outcomes
LOS Length of Stay
Time frame: hospitalisation time
mortality
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SAH (Subarachnoid Hemorrhage), run by Pomeranian Medical University Szczecin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GOS Glasgow Outcome Scale (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.