Clinical trial NCT06560372: Incidence, Characteristics and Evolution of Cerebral Vasospasm With Clinical Impact in Moderate to Severe Traumatic Brain Injury Complicated by Subarachnoid Hemorrhage at Martinique University Hospital
Official title: Incidence, Characteristics and Evolution of Cerebral Vasospasm With Clinical Impact in Moderate to Severe Traumatic Brain Injury Complicated by Subarachnoid Hemorrhage at Martinique University Hospital
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: SAH (Subarachnoid Hemorrhage)
Cerebral Vasospasm
Moderate Traumatic Brain Injury
Severe Traumatic Brain Injury
Keywords: SAH (Subarachnoid Hemorrhage)
Cerebral Vasospasm
Moderate and severe Traumatic Brain Injury
CT scan
Cerebral perfusion
Lead sponsor: University Hospital Center of Martinique
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients hospitalized at Martinique University Hospital for treatment or monitoring of a moderate or severe TBI (Glasgow Score less than or equal to 13 at initial treatment) presenting with SAH on initial cerebral CT scan
Primary purpose: DIAGNOSTIC

Brief summary: Context :

Moderate to severe head trauma with altered state of consciousness is an extremely common pathology (between 60 and 120 cases per 100 000 people per year depending on the country and age group), and is responsible for 30% of deaths by trauma. It is complicated in 30-60% of cases by subarachnoid hemorrhage (SAH), which makes it the leading cause of SAH. SAH and its complications are well described when the origin is aneurysmal, notably cerebral vasospasm (CV) because it promotes delayed cerebral ischemia with a major prognostic impact. This is why the screening and prevention of this vasospasm are well established in the literature and in practice, in the nosological context of aneurysmal SAH.

Research problem :

However, when it comes to post-traumatic SAH, CV is a more maligned entity, with a much less detailed description. However, when we know the prognostic interest that it could have for patients, it seems legitimate to seek to define its physiopathological and epidemiological contours. On a prospective cohort of 290 subjects, Oertel et al. (2005) demonstrated, in head trauma patients, an incidence of approximately 40% of compatible signs with the recognized criteria of CV.

To date, the literature remains sparse on this subject.

Proposed study :

In view of the incomplete scientific literature, the study team wish to carry out a prospective epidemiological study in moderate to severe head trauma patients complicated by SAH and hospitalized at the Martinique University Hospital, with the aim of better characterizing the incidence of the occurrence, and evolution of CV with clinical impact in these patients.

One of the original aspects of the proposed study is the use of CT scan with perfusion sequence, which has shown its superiority to Transcranial Doppler. The other particularity is its prospective aspect and triggered by an alteration in the clinical state of the patient presenting a traumatic SAH, then directly linking the pathophysiology (cerebral ischemia) and the clinical impact. Thus, the diagnosis of traumatic CV will be made on a cerebral CT scan by the association of the 50% reduction in the caliber of one or more cerebral arteries and a perfusion defect in the perfusion sequence in a context of alteration of neurological clinical examination or deterioration of neurological monitoring parameters. Finally, few studies have monitored the evolution of these patients at 1 and 6 months after the initial event.

Hypothesis :

The research hypothesis is that in the population of moderate to severe head trauma patients hospitalized at the Martinique University Hospital, when a new neurological symptomatology or a deterioration in the state of consciousness occurs, it could be a post-truamatic CV in 15 to 20% of cases.

Indeed, the rare studies find frequencies of radiologically confirmed CV in head trauma patients of around 30-45%, with low numbers of subjects, retrospective studies, or not correlated with the clinic and with the clinical and paraclinical data necessary for the positive diagnosis of this entity. The reported frequency of traumatic CV with clinical impact ranges between 15-20%.

The study team therefore expect an incidence of 15 to 20% of CV with clinical impact in patients with traumatic SAH in Martinique. CV could be responsible for sudden deterioration of the neurological state in patients suffering from traumatic SAH between the 3rd and 12th day inclusive of treatment (according to retrospective studies already carried out) and responsible for its specific morbidity linked to cerebral ischemia localized in the spasmed area manifested by a worsening of the neurological prognosis on the modified Rankin scale.


Eligibility criteria: Inclusion Criteria:

* Adult patient aged 18 or over,
* Hospitalized at the Martinique University Hospital for the treatment or monitoring of a moderate or severe TBI (Glasgow Score less than or equal to 13 at initial treatment) presenting with SAH on the cerebral CT scan,
* Patient if capable, or representative of the patient in case of incapacity, having been informed of the research, and having given free, informed and written consent,
* After an emergency inclusion procedure if the patient's representative is initially unreachable and written agreement, informed within the first 48 hours of inclusion by the representative or the patient if his neurological condition allows it,
* Be affiliated to a social security system.

Exclusion Criteria:

* Pregnant woman,
* Presence of an aneurysmal pathology known or diagnosed at initial treatment,
* History of chronic kidney failure stage 4 (creatinine clearance measured less than 30ml/min),
* Imminent death of the patient,
* Patient presenting criteria for non-admission to critical care (death expected within 48 hours, progressive fatal pathology with vital prognosis in less than 30 days, patient in palliative situation),
* Known allergy to iodized contrast products,
* Be placed under legal protection, guardianship or curatorship,
* Patient or representative who refused to allow the patient to participate in the study.

Additional Exclusion Criteria after patient's inclusion:

* Death of the patient expected within the first 48 hours,
* Minor,
* Release from hospitalization against medical advice,
* Transfer to another establishment before the 13th day of treatment (outside the Martinique University Hospital),
* Change of opinion of the patient's representative (after neurological recovery) regarding the patient's participation in research,
* Withdrawal of consent to participate in the study being supported with refusal to use the data collected until withdrawal of participation,

Primary outcomes:
measure: Estimate the incidence of cerebral vasospasm (CV) with clinical impact in moderate to severeTBI patients complicated by subarachnoid hemorrhage (SAH) at Martinique University Hospital.
timeFrame: 42 months
Secondary outcomes:
measure: Describe the characteristics of traumatic CV diagnosed in the study sample.
timeFrame: 42 months
measure: Describe the characteristics of traumatic CV diagnosed in the study sample.
timeFrame: 42 months
measure: Describe the characteristics of traumatic CV diagnosed in the study sample.
timeFrame: 42 months
measure: Describe the characteristics of traumatic CV diagnosed in the study sample.
timeFrame: 42 months
measure: Analyze the risk factors for the occurrence of traumatic CV.
timeFrame: 42 months
measure: Compare the neurological morbidity at 30 days and 6 months of patients with and without post-traumatic CV in the study sample.
timeFrame: 42 months
measure: Analyze the association between the worsening of the neurological prognosis 6 months after initial patient management, and the presence of a traumatic CV.
timeFrame: 42 months
measure: Assess quality of life at 6 months
timeFrame: 42 months
Other outcomes:
Locations:
city: Fort-de-France
country: France
facility: University Hospital Center of Martinique
Study officials:
affiliation: University Hospital Center of Martinique
name: Marie SABIA, PhD
role: PRINCIPAL_INVESTIGATOR
References: