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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06802588
Acronym
OPT-ICH
Enrollment
600
Registered
2025-01-31
Start date
2022-05-01
Completion date
2027-05-01
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral Hemorrhage

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, 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;

Interventions

None listed

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
mortality and disability6 months, 2 yearsPrimary 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.

Secondary

MeasureTime frameDescription
Neuropsychiatric patient profile among the survivors6 months, 2 yearsCognitive 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

Countries

France

Contacts

Primary ContactMarco PASI, MD, PHD
M.PASI@chu-tours.fr+33 0247478024

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026