Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2026-03-09 @ 4:50 PM
Study NCT ID:
NCT02261792
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2014-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spontaneous Intracranial Hypotension Treatment "SIHT"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019585', 'term': 'Intracranial Hypotension'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018475', 'term': 'Head-Down Tilt'}, {'id': 'D001510', 'term': 'Bed Rest'}, {'id': 'D017217', 'term': 'Blood Patch, Epidural'}], 'ancestors': [{'id': 'D011187', 'term': 'Posture'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D007268', 'term': 'Injections, Epidural'}, {'id': 'D007278', 'term': 'Injections, Spinal'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2014-09-26', 'studyFirstSubmitQcDate': '2014-10-07', 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recovery at Day 1 without relapse at Day 15', 'timeFrame': 'Day 1', 'description': 'V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety)'}, {'measure': 'Recovery at Day 1 without relapse at Day 15', 'timeFrame': 'day 15', 'description': 'V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety)'}], 'secondaryOutcomes': [{'measure': '2d EBP and other EBP', 'timeFrame': 'day 7, 15, 30 and 60', 'description': 'Number of patients requires a treatment with a second BP at any time of study (withdrawal study)'}, {'measure': 'Associated symptoms', 'timeFrame': 'day 1, 15, 30 and 60', 'description': 'Disappearance of associated symptoms'}, {'measure': 'Headache', 'timeFrame': 'day 1,15, 30 and 60', 'description': 'Pain scores, localisation and type of persistent headache at day 1,15, 30 and 60'}, {'measure': 'subdural hematoma surgery', 'timeFrame': 'day 7, 15, 30 and 60', 'description': 'Number of patients requires a surgery for life-threatening acute SDH'}, {'measure': 'cerebral MRI', 'timeFrame': 'day 30', 'description': 'results of D30 control MRI, compared to baseline MRI'}, {'measure': 'medullar MRI', 'timeFrame': 'day 60', 'description': 'results of baseline medullar MRI and the link between leak and patient recovery'}, {'measure': 'Epidural Blood Patch', 'timeFrame': 'day 60', 'description': 'Volume of blood and localisation of injection / statistical data related with recovery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postural headache treatment', 'Spontaneous intracranial hypotension', 'Epidural blood patch', 'Trendelenburg position', 'Head-Down Tilt', 'Blood Patch, Epidural'], 'conditions': ['Spontaneous Intracranial Hypotension']}, 'referencesModule': {'references': [{'pmid': '20050898', 'type': 'BACKGROUND', 'citation': 'Ferrante E, Arpino I, Citterio A, Wetzl R, Savino A. Epidural blood patch in Trendelenburg position pre-medicated with acetazolamide to treat spontaneous intracranial hypotension. Eur J Neurol. 2010 May;17(5):715-9. doi: 10.1111/j.1468-1331.2009.02913.x. Epub 2009 Dec 29.'}, {'pmid': '11723293', 'type': 'BACKGROUND', 'citation': 'Sencakova D, Mokri B, McClelland RL. The efficacy of epidural blood patch in spontaneous CSF leaks. Neurology. 2001 Nov 27;57(10):1921-3. doi: 10.1212/wnl.57.10.1921.'}]}, 'descriptionModule': {'briefSummary': 'Spontaneous intracranial hypotension (SIH) is an infrequent disease, related to a leak of cerebrospinal fluid. There are not controlled studies for this treatment.The main of this study is to demonstrate the superiority of the Trendelenburg position compared to supine position during 24 hours after an epidural blood patch for a spontaneous intracranial hypotension', 'detailedDescription': "Various treatments have been used for patient with spontaneous intracranial hypotension, but there is not definite approach. Some patients, fortunately, improve spontaneously. Bed rest and increased fluid intake have been advocate. The effectiveness of the caffeine has been shown in some studies, but durable beneficial effect is doubtful. The efficacy of steroids has not been established. However, although there have been no controlled studies, autologous epidural blood patch (EBP) can be considered the treatment of choice for patients. The success rate of EBP for a post lumbar puncture headache is about 90%, but for SIH, is very less about 50% after the first one and 77% after the second. The amount of blood injected must be sufficient. On the other hand, the leak is usually located on dorsal, above the prolonged rest must be respected. One study, have demonstrated, without randomization, a success rate of 90% with a prolonged Trendelenburg after EBP. We decided to do this study, to confirm a superiority of a 24 hours prolonged Trendelenburg position.\n\nIt's a monocentric study of parallel randomized open blind groups. Patients will be recruited by investigators in our headache emergency room. If the diagnose of SIH is confirmed (orthostatic headache from more than 5 days and less than 28 days with a normal MRI or with sign of SIH) study will be proposed.\n\nAfter a signed information, the patients will be randomized in 2 groups, the investigator is blind of the randomized arm of patient\n\n1. EBP with 24 hours bed rest\n2. EBP with 24 hours Trendelenburg position\n\nV1: inclusion V2 : 24 hours before EBP (headache, associated symptoms, HIT6) V3 : randomization and EBP V4 : first evaluation 30 minutes after standing (headaches, associated symptoms) V5 : phone evaluation (safety) D7 V6 : Evaluation at D15 (headache, associated symptoms, safety) V7 : Evaluation at D30 (headache, associated symptoms, control cerebral MRI, HIT6, safety) V8 : last evaluation D60 (headache, associated symptoms,HIT6 safety)\n\nCollection of 2nd EBP, 3rd EBP, 4th EBP throughout the study up to J 92 maximum"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years or more\n* No contraindication for BPE\n* Severe or moderate headache within 15 min standing, mild or no headache after 15 min bed rest\n* Headache from 5 to 28 days\n* Normal or evidence of low CSF on MRI\n* Signed informed consent\n\nExclusion Criteria:\n\n* Known dural leak in the previous 2 months the onset of headache\n* Abnormal MRI\n* First BPE for SIH\n* The patient has participated in another clinical trial than can interact with the evaluation\n* Contraindication of Trendelenburg position'}, 'identificationModule': {'nctId': 'NCT02261792', 'acronym': 'SIHT', 'briefTitle': 'Spontaneous Intracranial Hypotension Treatment "SIHT"', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Parallel Randomised Open Blind Evaluation Study of the Efficacy of 20° Trendelenburg Position During 24 Hours After Epidural Blood Patch in the Treatment of Spontaneous Intracranial Hypotension', 'orgStudyIdInfo': {'id': 'P111118'}, 'secondaryIdInfos': [{'id': '2013-AO1017-38', 'type': 'OTHER', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A : 24 hours bed rest', 'description': '24 hours bed rest', 'interventionNames': ['Procedure: 24 hours bed rest', 'Procedure: EBP']}, {'type': 'EXPERIMENTAL', 'label': 'B : 24 hours Trendelenburg position', 'description': '24 hours Trendelenburg position', 'interventionNames': ['Procedure: 24 hours Trendelenburg position', 'Procedure: EBP']}], 'interventions': [{'name': '24 hours Trendelenburg position', 'type': 'PROCEDURE', 'otherNames': ['inclination of the body at 20 degrees'], 'description': 'Trendelenburg position', 'armGroupLabels': ['B : 24 hours Trendelenburg position']}, {'name': '24 hours bed rest', 'type': 'PROCEDURE', 'otherNames': ['Allitement flat position for 24 hours'], 'description': '24 hours bed rest after EBP', 'armGroupLabels': ['A : 24 hours bed rest']}, {'name': 'EBP', 'type': 'PROCEDURE', 'otherNames': ['Epidural Blood Patch'], 'description': 'Autologous Epidural Blood Patch', 'armGroupLabels': ['A : 24 hours bed rest', 'B : 24 hours Trendelenburg position']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Lariboisiere Hospital - Centre Urgences Céphalées (CUC)', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Caroline ROOS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}