Lariboisiere Hospital - Centre Urgences Céphalées (CUC)
Paris, 75010, France
NCT Number: NCT02261792
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
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Paris, 75010, France
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.
It'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.
After a signed information, the patients will be randomized in 2 groups, the investigator is blind of the randomized arm of patient
V1: 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)
Collection of 2nd EBP, 3rd EBP, 4th EBP throughout the study up to J 92 maximum
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Trendelenburg position
Other names: inclination of the body at 20 degrees
24 hours bed rest after EBP
Other names: Allitement flat position for 24 hours
Autologous Epidural Blood Patch
Other names: Epidural Blood Patch
Time frame: Day 1
V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety)
Time frame: day 15
V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety)
Time frame: day 7, 15, 30 and 60
Number of patients requires a treatment with a second BP at any time of study (withdrawal study)
Time frame: day 1, 15, 30 and 60
Disappearance of associated symptoms
Time frame: day 1,15, 30 and 60
Pain scores, localisation and type of persistent headache at day 1,15, 30 and 60
Time frame: day 7, 15, 30 and 60
Number of patients requires a surgery for life-threatening acute SDH
Time frame: day 30
results of D30 control MRI, compared to baseline MRI
Time frame: day 60
results of baseline medullar MRI and the link between leak and patient recovery
Time frame: day 60
Volume of blood and localisation of injection / statistical data related with recovery
Assistance Publique - Hôpitaux de Paris
Other
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
Acronym: SIHT
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