Description of Clinicians' Predictive Abilities Before and After a Diffusion Tensor Imaging (DTI)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

With a mortality rate of over 13% in the neuro-intensive care unit, 86% of which are related to the withdrawal of active treatment, predicting a reliable neurological prognosis is of paramount importance in neuro-intensive care to help clinicians inform family members appropriately and tailor care to the patient's presumed wishes. This also helps justify aggressive resuscitation in patients with a presumed good prognosis and, conversely, avoid keeping patients with a poor neurological prognosis alive against their presumed wishes.

Current guidelines recommend multimodal neuro-prognostication, in which the clinician synthesizes prognostic data from the clinical examination, EEG, plasma or CSF biomarkers, and imaging to collaboratively develop an individualized prognosis, even though no study has evaluated the quality of this multimodal prognosis. Furthermore, existing variations depending on the nosological context make this approach complex and likely difficult to replicate.

Brain MRI is an important tool for neuroprognostics in patients with neurological injuries, and for this reason it is commonly used in clinical practice as part of this multimodal approach.

More specifically, brain MRI with diffusion tensor sequences is a validated prognostic tool in post-anoxic coma and traumatic brain injury, as well as, more recently, in subarachnoid hemorrhage, strokes, and hypoglycemia. However, it has not yet been compared to multimodal neuroprognostics performed by the clinician.

The primary objective is to compare the prognostic performance of two prescribing clinicians with diffusion tensor MRI before and after the MRI scan is performed.

Primary outcome measure: to compare the prognostic performance regarding unfavorable outcomes (Glasgow Outcome Scale Extended \< 5) at 12 months between the two prescribing clinicians and diffusion tensor MRI before and after the MRI scan is performed.

A secondary objective will be, among other things, to study the informational gain provided by MRI in improving clinicians' predictions after receiving the MRI results.

Intensive care clinicians constitute the target population. These are clinicians caring for an intensive care patient with a brain injury who order a brain MRI for prognostic purposes as part of patient care and multimodal neuroprognostics.

On the day of the MRI, two clinicians will complete the research questionnaire assessing the patient's prognosis the day before or a few hours before the MRI (on the same day). Then, as soon as the MRI results are available, the same two clinicians will complete the same questionnaire assessing the patient's prognosis after reviewing the MRI results. Patient data regarding the pathology and prognostic factors will be collected at this time.

Finally, surviving patients will be interviewed at 1 year regarding their independence using the Glasgow Outcome Scale Extended (GOSE) and their quality of life using the Medical Outcomes Study Short Form General Health Survey (SF-12) via a telephone call.

We plan to include 220 patients and approximately 70 clinicians across 8 recruiting centers over a 2-year enrollment period. With a 12-month follow-up period, the total duration of the study will be 3 years.

The statistical analysis will include a description of clinicians' ability to distinguish patient prognosis by measuring the area under the Receiver Operating Characteristic (ROC) curve, or AUC. The prediction concerns an unfavorable outcome, defined as a GOSE score of 1 to 4. Since we had no pre-study data on clinicians' performance in predicting an unfavorable outcome at the time of a prognostic MRI, the inclusion target was set based on data from a previous study at 220 patients, which corresponds to the number of patients we planned to enroll over a 2-year period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinicians with a medical degree

Prescribers of DTI for the following patients

Patients aged 18 years or older

Patients for whom a brain MRI with a DTI sequences is prescribed, during or following resuscitation as part of their care.

Disqualifiers

None

Trial population

Intensive care clinicians who care for patients in the intensive care unit with brain injury and who perform brain MRI for prognostic purposes as part of patient care and multimodal neuroprognostics, as well as those patients.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaire

    Other intervention

    Two clinicians will be interviewed the day before or the day of the brain MRI using a questionnaire. This questionnaire will also assess the physician's knowledge and the prognostic factors used to formulate their prognosis. A phone call will be made, blinded to the prognosis made before the MRI and without knowledge of the prognosis established by diffusion tensor MRI, 12 months after the brain injury. This call will be made by a person qualified to administer the questionnaires, in order to obtain a GOSE score.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Clinicians' ROC curve for predicting unfavorable patient outcomes at 12 months before MRI (Glasgow Outcome Scale Extended (GOSE <5)

The primary outcome measure is the clinicians' ROC curve for predicting unfavorable patient outcomes at 12 months before MRI (Glasgow Outcome Scale Extended (GOSE \<5). Two clinicians will be interviewed the day before or the day of the brain MRI using a questionnaire. This questionnaire will also assess the physician's knowledge and the prognostic factors used to formulate their prognosis. The clinician prognosis will be a number between 0 and 100, given by the clinician after this short explanation. "Now that you have all prognostic factors in mind, we would like your estimate of the patient's risk of an unfavorable outcome, on a scale of 0 to 100. This refers to a person who is unable to go shopping or travel independently, and who is unable to live independently, corresponding to a GOSE less than 5, one year after their brain injury." We will use the average of the two prognoses to construct the ROC curve.

Time frame
1 day before or the day of the MRI and 12 months after the brain injury

Secondary outcomes

1

Diffusion tensor Imaging's ROC curve for predicting unfavorable patient outcomes at 12 months (Glasgow Outcome Scale Extended (GOSE <5).

Prediction of the risk of unfavourable outcome (GOSE \< 5) by a statistical toll (Support vector machine) published in 2026 (Puybasset et al 2026 PMID : 41782003) using age, time between MRI and brain lesion as well as the mean and normalized value of the fractional anisotropy and mean diffusivity in the 17 regions of white matter defined by the Johns Hopkins Hospital Atlas. As described above, the assessment of unfavorable neurological outcomes will be based on the GOSE score.

Time frame
12 months
2

Clinicians' ROC curve for predicting unfavorable patient outcomes at 12 months before MRI (Glasgow Outcome Scale Extended (GOSE <4).

This secondary outcome measure is the clinicians' ROC curve for predicting unfavorable patient outcomes at 12 months (Glasgow Outcome Scale Extended (GOSE \<4). Two clinicians will be interviewed the day before or the day of the brain MRI using a questionnaire. This questionnaire will also assess the physician's knowledge and the prognostic factors used to formulate their prognosis. The clinician prognosis will be a number between 0 and 100, given by the clinician after this short explanation. As described above, the assessment of unfavorable neurological outcomes will be based on the GOSE score.

Time frame
12 months
3

Clinicians' ROC curve for predicting unfavorable patient outcomes at 12 months after MRI results (Glasgow Outcome Scale Extended (GOSE <5).

This secondary outcome measure is the clinicians' ROC curve for predicting unfavorable patient outcomes at 12 months just after MRI prediction (the same day) (GOSE \<5). Two clinicians will be interviewed the day after MRI prognosis using a questionnaire. This questionnaire will also assess the physician's knowledge and the prognostic factors used to formulate their prognosis. The clinician prognosis will be a number between 0 and 100, given by the clinician after this short explanation. As described above, the assessment of unfavorable neurological outcomes will be based on the GOSE score.

Time frame
12 months
4

Clinicians'ROC curve for predicting unfavorable patient outcomes at 12 months after MRI results (Glasgow Outcome Scale Extended (GOSE <4).

This secondary outcome measure is the clinicians' ROC curve for predicting unfavorable patient outcomes at 12 months just after MRI prediction (the same day) (GOSE \<4). Two clinicians will be interviewed the day after MRI prognosis using a questionnaire. This questionnaire will also assess the physician's knowledge and the prognostic factors used to formulate their prognosis. The clinician prognosis will be a number between 0 and 100, given by the clinician after this short explanation. As described above, the assessment of unfavorable neurological outcomes will be based on the GOSE score.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: