Clinical trial NCT04934332: Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma
Official title: Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma in a Post-intensive Care Rehabilitation Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heterotopic Ossification
Keywords: heterotopic ossification
post intensive care rehabilitation unit
early screening
ultrasound
neurological trauma
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Fondation Paul Bennetot
First posted: 2021-06-22
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Prospective, bi-centric diagnostic, performance study on a new diagnostic procedure with ultrasounds against a reference diagnostic procedure.

The primary objective is to study the performance of ultrasound coupled with clinical examination at 1 week of admission for early screening of heterotopic ossification (HO) in patients admitted to a post intensive care rehabilitation unit (PICRU) after a severe neurologic trauma.

The CT scan at 5 weeks of admission is considered as the gold standard. CT scan reader will be blinded to clinical data.

Detailed description: Heterotopic ossification still pose the problem of diagnosis and clinical management that is too late and invasive when complications arise. The challenge would be to identify patients at earlier stage of HO development in order to start an early treatment. This study will focus on the performance of ultrasound in the early screening of HO for patients admitted to a post intensive care rehabilitation unit after severe neurological trauma, this population being at high risk of HO.

Patient enrollment will be performed only at the PICRU of the Raymond Poincaré Hospital (AP-HP). Another center (the imaging department of the same hospital) will participate in this research for ultrasounds and CT scans, but will not perform any recruitment.

Eligibility criteria: Inclusion Criteria:

* Patients ⩾ 18 years;
* Admitted to a neurological post intensive care rehabilitation unit for the first time;
* Hospitalized in ICU before being admitted to PICRU for a for traumatic brain injury (initial Glasgow coma scale \< 14 and brain radiological abnormalities at the time of admission to ICU and / or a traumatic spinal cord injury (para- or tetraplegia with at least half of key muscles of the 2019 ISNCSCI classification with a strength of less than 3 below the neurological level of the injury at the time of admission to PICRU);
* Patient's written consent obtained (or from an authorized relative);
* Affiliation to a social security scheme.

Exclusion Criteria:

* History of moderate or severe traumatic brain injury;
* History of spinal cord injury (para- or tetraplegia);
* History of stroke or disabling neurological disease;
* History of hospitalization in neurological or neurosurgical or traumatological ICU for another reason;
* Breast-feeding or pregnancy;
* Under court protection.

Primary outcomes:
measure: Area under the ROC (receiver operating characteristic) curve at 1 week
timeFrame: at 1 week
Secondary outcomes:
measure: Sensitivity
timeFrame: at 1 week
measure: Specificity
timeFrame: at 1 week
measure: Positive predictive value and negative predictive value
timeFrame: at 1 week
measure: Likelihood-ratio of ultrasound
timeFrame: at 1 week
measure: Area under the ROC curve at 5 weeks
timeFrame: at 5 weeks
measure: Clinical examination
timeFrame: weekly from week-1 to week-5
Other outcomes:
Locations:
city: Garche
country: France
facility: Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
name: Julie PAQUEREAU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
name: Vincent T. CARPENTIER, MD
role: STUDY_DIRECTOR
References: