Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2025-12-31 @ 5:45 AM
Study NCT ID:
NCT06498804
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Blood Patch in the Management of Intracranial Hypotension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019585', 'term': 'Intracranial Hypotension'}, {'id': 'D051299', 'term': 'Post-Dural Puncture Headache'}, {'id': 'D014717', 'term': 'Vertigo'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D051271', 'term': 'Headache Disorders, Secondary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D015837', 'term': 'Vestibular Diseases'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-04', 'studyFirstSubmitDate': '2024-04-04', 'studyFirstSubmitQcDate': '2024-07-04', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Descriptions of professional practices in the management of intracranial hypotension by blood patch at the University Hospitals of Strasbourg', 'timeFrame': 'Through study completion, an average of 2 months', 'description': 'This retrospective study focuses on the description of the practices of doctors at the Strasbourg University Hospital in the management of intracranial hypotension by blood patch.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intracranial Hypotension', 'post-dural puncture headache', 'cranial nerve symptoms', 'hearing disturbances', 'vertigo'], 'conditions': ['Intracranial Hypotension']}, 'descriptionModule': {'briefSummary': 'Intracranial hypotension results from leakage and/or hypotension of cerebrospinal fluid. It can be spontaneous or secondary to a dural puncture complicating perimedullary anesthesia or a lumbar puncture. The incidence remains low with less than 1% post spinal puncture (25 gauge needle), but is observed more frequently following a lumbar puncture, up to 36% with a 20 or 22 gauge needle. Accidental puncture of the dura mater with a 17 gauge needle used for epidural anesthesia is associated with postpuncture headaches in 75-80% of cases. Classically, symptoms appear 24 to 48 hours after the puncture and consist of very intense, postural, fronto-occipital headaches which may be associated with cranial nerve symptoms such as visual or hearing disturbances or vertigo. Among the risk factors are the size and type of the needle, age under 60 and female gender. About 90% of PDPH are self-limiting within 7-10 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Major subject (≥18 years old) having benefited from a bloodpatch between 01/01/2021 and 12/31/2022', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major subject (≥18 years old)\n* Subject having benefited from a bloodpatch between 01/01/2021 and 12/31/2022\n\nExclusion Criteria:\n\n\\- Subject (and/or their legal representative if applicable) having expressed their (their) opposition to the reuse of their data for scientific research purposes'}, 'identificationModule': {'nctId': 'NCT06498804', 'acronym': 'BPIH', 'briefTitle': 'The Blood Patch in the Management of Intracranial Hypotension', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'The Blood Patch in the Management of Intracranial Hypotension: Description of a Population and Professional Practices', 'orgStudyIdInfo': {'id': '9059'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Stefanie KOESSLER, MD', 'role': 'CONTACT', 'email': 'stefanie.koessler@chru-strasbourg.fr', 'phone': '33 3 88 12 70 90'}, {'name': 'Stefanie KOESSLER, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Charlotte HILD, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Service d'Anesthésie Réanimation médecine Péri-Opératoire - CHU de Strasbourg - France", 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Stefanie KOESSLER, MD', 'role': 'CONTACT', 'email': 'stefanie.koessler@chru-strasbourg.fr', 'phone': '33 3 88 12 70 90'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}