Intracerebral HemorrhageNCT05501613
Early Multimodal Neuromonitoring For Spontaneous Intracerebral Hemorrhage (ICH)
An observational study of Intracerebral Hemorrhage and Critically Ill, run by Universidade do Porto at 1 site in Portugal.
Trial summary
The investigators intend to assess the predictive value of early (first 48 hours) multimodal neuromonitoring parameters concerning late survival in critically ill intracerebral hemorrhage (ICH) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Critically Ill, Intracranial Pressure
- What is being tested?
- Multimodal Neuromonitoring
- How many people
- 65 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2015to 1 Feb 2023
- 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: Critically Ill Spontaneous Intracerebral Hemorrhage Patients
Who may be able to join
- Spontaneous Intracerebral Hemorrhage
- ICU admission
- Need of Sedation and Ventilatory Support
- Need of Intracerebral Neuromonitoring
Who cannot join
- Etiology for Intracerebral hemorrhage such as tumor, vascular malformation, ischemic transformation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Multimodal Neuromonitoring Parameters as Prognostic Factors For Critically Ill Spontaneous ICH Patients
The investigators intend to assess the predictive value of early (first 48 hours) multimodal neuromonitoring parameters concerning late survival in critically ill intracerebral hemorrhage (ICH) patients.
Read the detailed description
Retrospective observational study based on analyzing the first 48 hours of the multimodal neuromonitoring signal, from spontaneous ICH patients, whose treatment includes invasive intraparenchymal neuromonitoring, treated from January 2015 to September 2021 in a tertiary hospital.
- Conditions
- Intracerebral Hemorrhage, Critically Ill, Intracranial Pressure, Cerebral Perfusion Pressure, Prognostic
- Being tested
- Multimodal Neuromonitoring
- Medical subject headings
- Cerebral Hemorrhage, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal NeuromonitoringDiagnostic test
Invasive Multimodal Neuromonitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
1 and 6 months survival
Measured: 1 and 6 months
Functional Outcome
6 month functional outcome with Modified Rankin Scale - 0 (No symptoms); 1 (No significant disability); 2 (Slight disability); 3 (Moderate disability); 4 (Moderately Severe Disability); 5 (Severe Disability); 6 (Dead).
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2022
- Study startJan 2015
- Primary completion1 Oct 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracerebral HemorrhageStudies 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
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Filipa Vaz Ferreira, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501613
- Sponsor's protocol ID
- 202201
- Status last verified
- Feb 2023
- First submitted
- 11 Aug 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ferreira A, Magalhaes J, Silva PA, Gregorio T, Monteiro E, Czosnyka M, Dias C. Early multimodal neuromonitoring is associated with outcomes in critically ill patients with hemorrhagic stroke. Front Neurol. 2026 May 21;17:1845374. doi: 10.3389/fneur.2026.1845374. eCollection 2026.
PubMed 42256563
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Multimodal Neuromonitoring Parameters as Prognostic Factors For Critically Ill Spontaneous ICH Patients
- ClinicalTrials.gov ID
- NCT05501613
- Acronym / sponsor ID
- 202201
- Conditions
- Intracerebral Hemorrhage, Critically Ill, Intracranial Pressure, Cerebral Perfusion Pressure, Prognostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 15 Aug 2022 (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.
The investigators intend to assess the predictive value of early (first 48 hours) multimodal neuromonitoring parameters concerning late survival in critically ill intracerebral hemorrhage (ICH) patients.
Detailed description
Retrospective observational study based on analyzing the first 48 hours of the multimodal neuromonitoring signal, from spontaneous ICH patients, whose treatment includes invasive intraparenchymal neuromonitoring, treated from January 2015 to September 2021 in a tertiary hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically Ill Spontaneous Intracerebral Hemorrhage Patients
Key inclusion criteria (4 listed)
- Spontaneous Intracerebral Hemorrhage
- ICU admission
- Need of Sedation and Ventilatory Support
- Need of Intracerebral Neuromonitoring
Key exclusion criteria (1 listed)
- Etiology for Intracerebral hemorrhage such as tumor, vascular malformation, ischemic transformation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal NeuromonitoringInvasive Multimodal Neuromonitoring | Diagnostic test | – |
Primary outcome
Survival
Time frame: 1 and 6 months
1 and 6 months survival
Functional Outcome
Time frame: 6 month
6 month functional outcome with Modified Rankin Scale - 0 (No symptoms); 1 (No significant disability); 2 (Slight disability); 3 (Moderate disability); 4 (Moderately Severe Disability); 5 (Severe Disability); 6 (Dead).
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 6 Feb 2023.
- Derived from this study: PubMed 42256563Ferreira A, Magalhaes J, Silva PA, Gregorio T, Monteiro E, Czosnyka M, Dias C. Early multimodal neuromonitoring is associated with outcomes in critically ill patients with hemorrhagic stroke. Front Neurol. 2026 May 21;17:1845374. doi: 10.3389/fneur.2026.1845374. eCollection 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Intracerebral Hemorrhage
Not yet recruiting
BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Aphasia (BG-Aphasia-01)
Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Recruiting
Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
Intracerebral Haemorrhage, Minimally Invasive Treatment
RecruitingObservational study
Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
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 Intracerebral Hemorrhage and Critically Ill, run by Universidade do Porto at 1 site in Portugal.
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 4 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 6 Feb 2023. 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 Portugal. 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?
Survival (time frame: 1 and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05501613, which also lists 1 linked publication.
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 6 Feb 2023.