Intracerebral HemorrhageOPT-ICHNCT06802588
Optimization of the Management of Non-Traumatic Intracerebral Hemorrhage (OPT-ICH)
An observational study of Intracerebral Hemorrhage, run by University Hospital, Tours at 3 sites in France.
Trial summary
Intracerebral non-traumatic intraparenchymal hemorrhages (ICH) account for 15 to 20% of strokes. One third of the patients dies within the month following ICH, and survivors often experience residual disability with a high risk of recurrent ICH, other serious vascular events, and neurological complications such as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage
- How many people
- 600 participants
- Where
- 3 sitesFrance
- Study dates
- 1 May 2022to 1 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult population with acute ICH
Who may be able to join
- aged over 18 years
- emergency admission to the University Hospital of Tours
- having an ICH on imaging performed upon admission (CT scan or MRI) at the University Hospital of Tours
Who cannot join
- Patient who has given their opposition to the collection of their data
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 3 recruiting
- Recruiting
University Hospital of Angers
Angers, 49100
GODARD Sophie, MD, 02 41 35 36 37 ext. +33, s.godard@chu-angers.fr
- Recruiting
University Hospital of Poitiers
Poitiers, 86000
LAMY Matthias, MD, 05 49 44 44 44 ext. +33, m.lamy@chu-poitiers.fr
- Recruiting
University Hospital Center of Tours
Tours, 37044
Marco PASI, MD,PhD, m.pasi@chu-tours.fr
Marco PASI, MD,PhD
About this study
Intracerebral non-traumatic intraparenchymal hemorrhages (ICH) account for 15 to 20% of strokes. One third of the patients dies within the month following ICH, and survivors often experience residual disability with a high risk of recurrent ICH, other serious vascular events, and neurological complications such as epilepsy and dementia. Encouraging but preliminary data suggest a favorable trend in terms of survival rates in recent years. This is partly due to improved management of patients with ICH, which must be early (the concept of "time is brain") and carried out by expert personnel (medical and paramedical) in specialized units.
The main objectives of the study are:
- To evaluate the management of patients with ICH in the acute phase within the University Hospital of Tours by analyzing the procedures adopted in the various relevant departments (neurovascular units, neurosurgery, medical or neurosurgical intensive care, geriatrics);
- To evaluate whether the systematic implementation of a dedicated protocol (see *) for the management of patients with ICH is associated with a reduction in mortality and disability in the short and long term.
Read the detailed description
The project consists of 2 parts:
- Retrospective, multicentric, observational study. Inclusion of all patients presenting with ICH admitted urgently to the University Hospital of Tours between 2018-2021.
- Prospective, multicentric, observational study. Inclusion of all patients presenting with ICH admitted urgently to the University Hospital of Tours, Angers and Poitiers.
Each patient will benefit from management according to a protocol which will include:
- Emergency MRI with contrast injection (contrast-enhanced brain CT scan if contraindicated);
- Admission to the Neurovascular Unit unless hemodynamically unstable or intubated;
- First intravenous antihypertensive injection with a goal < 1 hour from arrival at the hospital;
- Anticoagulation reversal with a goal < 1 hour from arrival at the hospital;
- Standard laboratory tests + coagulation study ;
- Neurosurgical consultation upon arrival at the department;
- Follow-up MRI at 24-48 hours or earlier if clinical worsening;
- Diagnostic work-up for the evaluation of hypertension-related end organ damage (Transthoracic echocardiogram, retinography , proteinuria);
- Contrast-enhanced follow-up MRI at 3-6 months;
- Neurological evaluation at 6 months and 2 years;
- When applicable a neuropsychological evaluation at 6M and 2 Y;
- Conditions
- Intracerebral Hemorrhage
- Medical subject headings
- Cerebral Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality and disability
Primary Outcome Measure Title:
Modified Rankin Scale (mRS) Scores to Assess Disability and Mortality
Description:
The study will evaluate functional outcomes, disability, and mortality in patients with non-traumatic intracerebral hemorrhage. Functional outcomes will be measured using the modified Rankin Scale (mRS), which evaluates the degree of disability or dependence in daily activities. The mRS scores range from 0 (no symptoms) to 6 (death). Data will be summarized as the proportion of participants in each mRS category at 6 months and 2 years. Mortality will be assessed as the percentage of participants with an mRS score of 6.
Measured: 6 months, 2 years
Secondary outcomes (1)
Neuropsychiatric patient profile among the survivors
Cognitive and behavioral outcomes will be measured using a battery of neuropsychiatric tests, including assessments for memory, executive function, attention, and mood disorders (e.g., depression and anxiety). Data will be reported as mean test scores for each domain
Measured: 6 months, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 May 2022
- Primary completion1 May 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marco PASI, MD, PHD, Principal investigator, neurovascular unit, neurology department, CHRU ToursGrégoire Boulouis, MD, PHD, Principal investigator, interventionnal neuroradiology unit, neuroradiology department, CHRU Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802588
- Sponsor's protocol ID
- 2022_011
- Acronym
- OPT-ICH
- Status last verified
- Jan 2026
- First submitted
- 7 Jan 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of the Management of Non-Traumatic Intracerebral Hemorrhage (OPT-ICH)
- ClinicalTrials.gov ID
- NCT06802588
- Acronym / sponsor ID
- OPT-ICH / 2022_011
- Conditions
- Intracerebral Hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 31 Jan 2025 (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.
Intracerebral non-traumatic intraparenchymal hemorrhages (ICH) account for 15 to 20% of strokes. One third of the patients dies within the month following ICH, and survivors often experience residual disability with a high risk of recurrent ICH, other serious vascular events, and neurological complications such as epilepsy and dementia. Encouraging but preliminary data suggest a favorable trend in terms of survival rates in recent years. This is partly due to improved management of patients with ICH, which must be early (the concept of "time is brain") and carried out by expert personnel (medical and paramedical) in specialized units.
The main objectives of the study are:
- To evaluate the management of patients with ICH in the acute phase within the University Hospital of Tours by analyzing the procedures adopted in the various relevant departments (neurovascular units, neurosurgery, medical or neurosurgical intensive care, geriatrics);
- To evaluate whether the systematic implementation of a dedicated protocol (see *) for the management of patients with ICH is associated with a reduction in mortality and disability in the short and long term.
Detailed description
The project consists of 2 parts:
- Retrospective, multicentric, observational study. Inclusion of all patients presenting with ICH admitted urgently to the University Hospital of Tours between 2018-2021.
- Prospective, multicentric, observational study. Inclusion of all patients presenting with ICH admitted urgently to the University Hospital of Tours, Angers and Poitiers.
Each patient will benefit from management according to a protocol which will include:
- Emergency MRI with contrast injection (contrast-enhanced brain CT scan if contraindicated);
- Admission to the Neurovascular Unit unless hemodynamically unstable or intubated;
- First intravenous antihypertensive injection with a goal < 1 hour from arrival at the hospital;
- Anticoagulation reversal with a goal < 1 hour from arrival at the hospital;
- Standard laboratory tests + coagulation study ;
- Neurosurgical consultation upon arrival at the department;
- Follow-up MRI at 24-48 hours or earlier if clinical worsening;
- Diagnostic work-up for the evaluation of hypertension-related end organ damage (Transthoracic echocardiogram, retinography , proteinuria);
- Contrast-enhanced follow-up MRI at 3-6 months;
- Neurological evaluation at 6 months and 2 years;
- When applicable a neuropsychological evaluation at 6M and 2 Y;
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult population with acute ICH
Key inclusion criteria (3 listed)
- aged over 18 years
- emergency admission to the University Hospital of Tours
- having an ICH on imaging performed upon admission (CT scan or MRI) at the University Hospital of Tours
Key exclusion criteria (1 listed)
- Patient who has given their opposition to the collection of their data
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
mortality and disability
Time frame: 6 months, 2 years
Primary Outcome Measure Title: Modified Rankin Scale (mRS) Scores to Assess Disability and Mortality Description: The study will evaluate functional outcomes, disability, and mortality in patients with non-traumatic intracerebral hemorrhage. Functional outcomes will be measured using the modified Rankin Scale (mRS), which evaluates the degree of disability or dependence in daily activities. The mRS scores range from 0 (no symptoms) to 6 (death). Data will be summarized as the proportion of participants in each mRS category at 6 months and 2 years. Mortality will be assessed as the percentage of participants with an mRS score of 6.
1 secondary outcome
Neuropsychiatric patient profile among the survivors
Time frame: 6 months, 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Marco PASI, MD, PHD principal investigator
neurovascular unit, neurology department, CHRU Tours
Grégoire Boulouis, MD, PHD principal investigator
interventionnal neuroradiology unit, neuroradiology department, CHRU Tours
3 sites 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, run by University Hospital, Tours at 3 sites in France.
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 3 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: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marco PASI, MD, PHD (+33 0247478024, M.PASI@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality and disability (time frame: 6 months, 2 years). 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 15 Jan 2026.