Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
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

Led by University Hospital Center of Martinique · Updated on 2025-03-31

154

Participants Needed

1

Research Sites

213 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patient aged 18 or over
  • Hospitalized at Martinique University Hospital for moderate or severe traumatic brain injury with subarachnoid hemorrhage on cerebral CT scan
  • Patient or legal representative has given free, informed, and written consent
  • Emergency inclusion allowed if consent obtained within 48 hours from patient or representative
  • Affiliated with a social security system
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Known or newly diagnosed aneurysmal pathology at initial treatment
  • Chronic kidney failure stage 4 (creatinine clearance under 30 ml/min)
  • Imminent death expected
  • Criteria for non-admission to critical care (death expected within 48 hours, fatal illness with prognosis under 30 days, palliative care situation)
  • Allergy to iodized contrast products
  • Under legal protection, guardianship, or curatorship
  • Patient or representative refusal to participate
  • Death expected within 48 hours after inclusion
  • Minor patients
  • Leaving hospital against medical advice
  • Transfer to another facility before 13th day of treatment
  • Withdrawal of consent or change of representative's opinion after neurological recovery

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Trial Site Locations

Total: 1 location

1

University Hospital Center of Martinique

Fort-de-France, France, 97261

Actively Recruiting

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Research Team

M

Marie SABIA, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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