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Search / Trial NCT00577954

Multimodal Resonance Imaging for Outcome Prediction on Coma Patients

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Dec 19, 2007

Trial Information

Current as of August 11, 2025

Completed

Keywords

Coma Tbi Stroke Sah Cerebral Anoxia Multimodal Mri

ClinConnect Summary

Predicting the awakening of patients in comas is one of the principal stakes of the current neurointensive care unit (neuroICU). Several studies and clinical practice suggest that the multimodal MRI, which associates the traditional morphological sequences (T1, T2\*, FLAIR/T2), the spectroscopy-MRI (MRS) and the diffusion tensor imaging, is a tool allowing such a prediction. However, this strategy has not been yet validated. Additionally, currently there is no method of analysis including the 4 different sequences.

Objective: The goal of this study is to develop a composite score able to p...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Adult affiliated to the social security system
  • Hospitalized in neuroICU and requiring artificial ventilation following a severe cranial trauma, an ischemic and/or hemorrhagic cerebrovascular accident and/or a cerebral anoxia
  • In coma defined as not answering simple orders at least 7 days after the event
  • Receiving an amount of sedatives and not being able to explain the coma
  • Having a standardized intracranial pressure (≤ 15 mm Hg) and in absence of severe hemodynamic or respiratory failure so that the MRI does not represent any additional danger
  • Exclusion Criteria:
  • Coma of infectious or toxic origin
  • Coma explained by sedation
  • MRI contraindication (pace maker, medical material not MRI compatible)
  • Persistent intracranial hypertension contraindicating the setting in prolonged dorsal decubitus (ICP \> 20 mm Hg during more than 10 minutes after positioning on decubitus)
  • Severe hemodynamic failure
  • Severe respiratory failure
  • Life threatening extra-cerebral lesions
  • Cranial trauma of ballistic origin
  • Patient presenting a severe compromise of a major function bringing into play the vital outcome, with invalidity before the accident/event
  • Former neurological pathology altering the clinical outcome of the cranial trauma
  • Refusal of the family
  • Patient protected by the law (under supervision or trusteeship)

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Paris, , France

Patients applied

0 patients applied

Trial Officials

Pr Louis Puybasset,, MD, PhD

Principal Investigator

Assistance Publique Hopitaux de Paris Pitié Salpetriere

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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