Clinical Trial: Spontaneous Intracranial Hypotension Treatment "SIHT"
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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 Intr
Brief Summary: 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
Detailed Summary:
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
- EBP with 24 hours bed rest
- EBP with 24 hours Trendelenburg position
V1: inclusion V2 : 24 hours before EBP (headache, associated symptoms, HIT6) V3 : randomization and EBP
Sponsor: Assistance Publique - Hôpitaux de Paris
Current Primary Outcome:
- Recovery at Day 1 without relapse at Day 15 [ Time Frame: Day 1 ]V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety)
- Recovery at Day 1 without relapse at Day 15 [ Time Frame: day 15 ]V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety)
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 2d EBP and other EBP [ 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)
- Associated symptoms [ Time Frame: day 1, 15, 30 and 60 ]Disappearance of associated symptoms
- Headache [ Time Frame: day 1,15, 30 and 60 ]Pain scores, localisation and type of persistent headache at day 1,15, 30 and 60
- subdural hematoma surgery [ Time Frame: day 7, 15, 30 and 60 ]Number of patients requires a surgery for life-threatening acute SDH
- cerebral MRI [ Time Frame: day 30 ]results of D30 control MRI, compared to baseline MRI
- medullar MRI [ Time Frame: day 60 ]results of baseline medullar MRI and the link between leak and patient recovery
- Epidural Blood Patch [ Time Frame: day 60 ]Volume of blood and localisation of injection / statistical data related with recovery
Original Secondary Outcome:
- 2d EBP [ 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)
- Associated symptoms [ Time Frame: day 1, 15, 30 and 60 ]Disappearance of associated symptoms
- Headache [ Time Frame: day 1,15, 30 and 60 ]Pain scores, localisation and type of persistent headache at day 1,15, 30 and 60
- subdural hematoma surgery [ Time Frame: day 7, 15, 30 and 60 ]Number of patients requires a surgery for life-threatening acute SDH
- cerebral MRI [ Time Frame: day 30 ]results of D30 control MRI, compared to baseline MRI
- medullar MRI [ Time Frame: day 60 ]results of baseline medullar MRI and the link between leak and patient recovery
- Epidural Blood Patch [ Time Frame: day 60 ]Volume of blood and localisation of injection / statistical data related with recovery
Information By: Assistance Publique - Hôpitaux de Paris
Dates:
Date Received: September 26, 2014
Date Started: December 2014
Date Completion: December 2018
Last Updated: January 3, 2017
Last Verified: December 2016
