Optimization of the Management of Non-Traumatic Intracerebral Hemorrhage (OPT-ICH)

Phase

N/A

Condition

Stroke

Brain Injury

Hemorrhage

Treatment

N/A

Clinical Study ID

NCT06802588

2022_011

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Study Design

May 01, 2022

May 01, 2027

Study 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;

Connect with a study center

University Hospital of Angers
Angers 3037656, 49100
France
Active - Recruiting
University Hospital of Poitiers
Poitiers 2986495, 86000
France
Active - Recruiting
University Hospital Center of Tours
Tours, 37044
France
Site Not Available
University Hospital Center of Tours
Tours 2972191, 37044
France
Active - Recruiting

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