UnknownNot Applicable

Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma

France80 participantsStarted 2022-03-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area under the ROC (receiver operating characteristic) curve at 1 week

Timeframe: at 1 week

Trial details

NCT IDNCT04934332

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01

Contact for this trial

Julie PAQUEREAU, MD

+33 1 47 10 70 82 julie.paquereau@aphp.fr

View on ClinicalTrials.gov More Heterotopic Ossification trials