Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
NCT06402968
Brain Diseases, Cardiovascular Diseases
Irvine, California, United States
View Trial DetailsNCT Number: NCT06802588
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
University Hospital of Angers, Angers, France
The project consists of 2 parts:
Each patient will benefit from management according to a protocol which will include:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 6 months, 2 years
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
Contact information is provided by the study sponsor or research team.
University Hospital, Tours
Other
Acronym: OPT-ICH
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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