Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-01-01 @ 8:27 AM
Study NCT ID:
NCT04934332
Status:
UNKNOWN
Last Update Posted:
2023-03-17
First Post:
2021-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009999', 'term': 'Ossification, Heterotopic'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019220', 'term': 'High-Energy Shock Waves'}, {'id': 'D012149', 'term': 'Restraint, Physical'}], 'ancestors': [{'id': 'D000069453', 'term': 'Ultrasonic Waves'}, {'id': 'D013016', 'term': 'Sound'}, {'id': 'D011840', 'term': 'Radiation, Nonionizing'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D032763', 'term': 'Behavior Control'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007103', 'term': 'Immobilization'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-15', 'studyFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2021-06-14', 'lastUpdatePostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the ROC (receiver operating characteristic) curve at 1 week', 'timeFrame': 'at 1 week', 'description': 'Area under the ROC curve of ultrasound examination at 1 week compared CT scan at 5 weeks for making the diagnosis of HO.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': 'at 1 week', 'description': 'Sensitivity of ultrasound examination at 1 week for making the diagnosis of HO, the CT scan at 5 weeks of admission being considered as the gold standard.'}, {'measure': 'Specificity', 'timeFrame': 'at 1 week', 'description': 'Specificity of ultrasound examination at 1 week for making the diagnosis of HO, the CT scan at 5 weeks of admission being considered as the gold standard.'}, {'measure': 'Positive predictive value and negative predictive value', 'timeFrame': 'at 1 week', 'description': 'Positive predictive value and negative predictive value of ultrasound examination at 1 week for making the diagnosis of HO, the CT scan at 5 weeks of admission being considered as the gold standard.'}, {'measure': 'Likelihood-ratio of ultrasound', 'timeFrame': 'at 1 week', 'description': 'Likelihood-ratio of ultrasound examination at 1 week for making the diagnosis of HO, the CT scan at 5 weeks of admission being considered as the gold standard.'}, {'measure': 'Area under the ROC curve at 5 weeks', 'timeFrame': 'at 5 weeks', 'description': 'Area under the ROC curve of ultrasound examination at 5 weeks compared with CT scan at 5 weeks for making the diagnosis of HO.'}, {'measure': 'Clinical examination', 'timeFrame': 'weekly from week-1 to week-5', 'description': 'Area under the ROC curve of clinical examination at 1, 2, 3, 4, 5 weeks of admission compared with CT scan at 5 weeks to screen HO.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heterotopic ossification', 'post intensive care rehabilitation unit', 'early screening', 'ultrasound', 'neurological trauma'], 'conditions': ['Heterotopic Ossification']}, 'descriptionModule': {'briefSummary': 'Prospective, bi-centric diagnostic, performance study on a new diagnostic procedure with ultrasounds against a reference diagnostic procedure.\n\nThe 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.\n\nThe CT scan at 5 weeks of admission is considered as the gold standard. CT scan reader will be blinded to clinical data.', 'detailedDescription': '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.\n\nPatient 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ⩾ 18 years;\n* Admitted to a neurological post intensive care rehabilitation unit for the first time;\n* 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);\n* Patient's written consent obtained (or from an authorized relative);\n* Affiliation to a social security scheme.\n\nExclusion Criteria:\n\n* History of moderate or severe traumatic brain injury;\n* History of spinal cord injury (para- or tetraplegia);\n* History of stroke or disabling neurological disease;\n* History of hospitalization in neurological or neurosurgical or traumatological ICU for another reason;\n* Breast-feeding or pregnancy;\n* Under court protection."}, 'identificationModule': {'nctId': 'NCT04934332', 'acronym': 'POHER II', 'briefTitle': 'Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Early Ultrasound Screening of Heterotopic Ossification After Severe Neurological Trauma in a Post-intensive Care Rehabilitation Unit', 'orgStudyIdInfo': {'id': 'APHP210785'}, 'secondaryIdInfos': [{'id': 'IDRCB 2021-A01096-35', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Newly hospitalized patients', 'description': 'Patients admitted for the first time to a post intensive care rehabilitation unit after severe neurological trauma.', 'interventionNames': ['Procedure: Ultrasound', 'Procedure: CT scan', 'Procedure: Clinical examination']}], 'interventions': [{'name': 'Ultrasound', 'type': 'PROCEDURE', 'description': 'Ultrasound examination at 1 week and 5 weeks after admission.', 'armGroupLabels': ['Newly hospitalized patients']}, {'name': 'CT scan', 'type': 'PROCEDURE', 'description': 'CT scan at 5 weeks after admission. CT scan reader will be blinded to clinical data.', 'armGroupLabels': ['Newly hospitalized patients']}, {'name': 'Clinical examination', 'type': 'PROCEDURE', 'description': 'Weekly clinical examination from week-2 to week-5.', 'armGroupLabels': ['Newly hospitalized patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92380', 'city': 'Garche', 'status': 'RECRUITING', 'country': 'France', 'facility': 'Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP', 'geoPoint': {'lat': 49.39455, 'lon': 6.19775}}], 'centralContacts': [{'name': 'Julie PAQUEREAU, MD', 'role': 'CONTACT', 'email': 'julie.paquereau@aphp.fr', 'phone': '+33 1 47 10 70 82'}, {'name': 'Vincent T. CARPENTIER, MD-MSc', 'role': 'CONTACT', 'email': 'vincent.carpentier@aphp.fr', 'phone': '+33 1 47 10 70 82'}], 'overallOfficials': [{'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', 'affiliation': 'Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondation Paul Bennetot', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}