Clinical trial NCT06802588: Optimization of the Management of Non-Traumatic Intracerebral Hemorrhage (OPT-ICH)
Official title: Optimization of the Management of Non-Traumatic Intracerebral Hemorrhage (OPT-ICH)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracerebral Hemorrhage
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult population with acute ICH

Brief 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 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, monocentric, observational study. Inclusion of all patients presenting with ICH admitted urgently to the University Hospital of Tours between 2018-2021.
* Prospective, monocentric, observational study. Inclusion of all patients presenting with ICH admitted urgently to the University Hospital of Tours.

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;

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion criteria :

- Patient who has given their opposition to the collection of their data

Primary outcomes:
measure: mortality and disability
timeFrame: 6 months, 2 years
Secondary outcomes:
measure: Neuropsychiatric patient profile among the survivors
timeFrame: 6 months, 2 years
Other outcomes:
Locations:
city: Tours
country: France
facility: University Hospital Center of Tours
Study officials:
affiliation: neurovascular unit, neurology department, CHRU Tours
name: Marco PASI, MD, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: interventionnal neuroradiology unit, neuroradiology department, CHRU Tours
name: Grégoire Boulouis, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: