Understanding cerebral vasospasm in traumatic brain injury with subarachnoid hemorrhage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the incidence and characteristics of cerebral vasospasm in patients suffering from moderate to severe traumatic brain injury complicated by subarachnoid hemorrhage. It aims to enhance the understanding of this condition, which is often overlooked in post-traumatic scenarios, by utilizing brain perfusion scans to diagnose vasospasm. The research will be conducted at the Martinique University Hospital, focusing on adult patients with specific eligibility criteria. The goal is to gather data that could improve patient outcomes through better screening and prevention strategies.

Why it matters

Who can join: the full rules

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,

Where it's running

• University Hospital Center of Martinique
  Fort-de-France, France Recruiting

Study contacts

• Principal investigator: Marie SABIA, PhD — University Hospital Center of Martinique
• Study coordinator: Marie SABIA, PhD
• Email: marie.sabia@chu-martinique.fr
• Phone: 05 96 55 10 54

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Dual-Site Ear Nerve Stimulation for Severe Brain Injury-Related Coma

  This study tests a gentle, non-invasive stimulation on the left ear to try to help some people in coma due to severe traumatic brain injury regain awareness.

  Recruiting Stony Brook University · Stony Brook, New York · NCT07719595

• Neutral fluid balance in adults with traumatic brain injury (LIMIT-TBI)

  This study tests whether keeping daily fluid balance around zero (within 500 mL) for the first 5 days in the ICU is feasible and safe for adults with traumatic brain injury.

  Recruiting at 3 sites Phase 2 Erasme University Hospital · Brussels and 2 other locations · NCT07625995

• Nitric Oxide Use to Predict Vasospasm in Aneurysmal Subarachnoid Hemorrhage

  This study tests whether nitric oxide consumption in CSF can predict cerebral vasospasm in patients with aneurysmal SAH.

  Recruiting at 2 sites Massachusetts General Hospital · Boston, Massachusetts and 1 other locations · NCT07614906

• SeeMe: automated facial and hand tracking to reveal hidden responses after traumatic brain injury

  This project tests whether a high-resolution camera system with AI can detect very small, voluntary facial and hand movements in adults with severe traumatic brain injury who appear unresponsive.

  Recruiting Stony Brook University · Stony Brook, New York · NCT07560631

• Prognostic model for neurocritical patients using multimodal brain monitoring

  This study tests a model that uses EEG, TCD, and NIRS data to predict 90-day outcomes (awake, coma, or death) in adults with acute brain injuries in intensive care.

  Recruiting Xiangya Hospital of Central South University · Changsha, Hunan · NCT07115459

• Cerebral Vasospasm Registry Using NeVa VS After Aneurysmal Subarachnoid Hemorrhage

  This registry tests the NeVa VS device in adults with symptomatic cerebral vasospasm after an aneurysmal subarachnoid hemorrhage to see how it performs in real-world centers.

  Recruiting at 16 sites Vesalio · Burbank, California and 15 other locations · NCT06893588

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.