Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma

NCT ID: NCT04934332

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2024-01-31

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.

Conditions

Heterotopic Ossification

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Newly hospitalized patients

Patients admitted for the first time to a post intensive care rehabilitation unit after severe neurological trauma.

Group Type: EXPERIMENTAL

Ultrasound

Intervention Type: PROCEDURE

Ultrasound examination at 1 week and 5 weeks after admission.

CT scan

Intervention Type: PROCEDURE

CT scan at 5 weeks after admission. CT scan reader will be blinded to clinical data.

Clinical examination

Intervention Type: PROCEDURE

Weekly clinical examination from week-2 to week-5.

Interventions

Ultrasound

Ultrasound examination at 1 week and 5 weeks after admission.

Intervention Type: PROCEDURE

CT scan

CT scan at 5 weeks after admission. CT scan reader will be blinded to clinical data.

Intervention Type: PROCEDURE

Clinical examination

Weekly clinical examination from week-2 to week-5.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Paul Bennetot

OTHER

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julie PAQUEREAU, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

Vincent T. CARPENTIER, MD

Role: STUDY_DIRECTOR

Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France

Locations

Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP

Garche, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Julie PAQUEREAU, MD

Role: CONTACT

julie.paquereau@aphp.fr

+33 1 47 10 70 82

Vincent T. CARPENTIER, MD-MSc

Role: CONTACT

vincent.carpentier@aphp.fr

+33 1 47 10 70 82

Other Identifiers

IDRCB 2021-A01096-35

Identifier Type: OTHER

Identifier Source: secondary_id

APHP210785

Identifier Type: -

Identifier Source: org_study_id