Spontaneous Intracranial Hypotension Treatment "SIHT"

Spontaneous Intracranial Hypotension Clinical Trial

— SIHT  

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 Intracranial Hypotension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02261792
• Other study ID #: P111118
• Secondary ID: 2013-AO1017-38
• Status: Completed
• Phase: N/A
• Start date: December 2014
• Est. completion date: March 8, 2021

Study information

• Verified date: April 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

1. EBP with 24 hours bed rest

2. EBP with 24 hours Trendelenburg position

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 8, 2021
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or more

• No contraindication for BPE

• Severe or moderate headache within 15 min standing, mild or no headache after 15 min bed rest

• Headache from 5 to 28 days

• Normal or evidence of low CSF on MRI

• Signed informed consent

Exclusion Criteria:

• Known dural leak in the previous 2 months the onset of headache

• Abnormal MRI

• First BPE for SIH

• The patient has participated in another clinical trial than can interact with the evaluation

• Contraindication of Trendelenburg position

Related Conditions & MeSH terms

• Hypotension
• Intracranial Hypotension
• Spontaneous Intracranial Hypotension

Intervention

Procedure:
• 24 hours Trendelenburg position
Trendelenburg position
• 24 hours bed rest
24 hours bed rest after EBP
• EBP
Autologous Epidural Blood Patch

Locations

Country	Name	City	State
France	Lariboisiere Hospital - Centre Urgences Céphalées (CUC)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recovery at Day 1 without relapse at Day 15	V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety)	Day 1
Primary	Recovery at Day 1 without relapse at Day 15	V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety)	day 15
Secondary	2d EBP and other EBP	Number of patients requires a treatment with a second BP at any time of study (withdrawal study)	day 7, 15, 30 and 60
Secondary	Associated symptoms	Disappearance of associated symptoms	day 1, 15, 30 and 60
Secondary	Headache	Pain scores, localisation and type of persistent headache at day 1,15, 30 and 60	day 1,15, 30 and 60
Secondary	subdural hematoma surgery	Number of patients requires a surgery for life-threatening acute SDH	day 7, 15, 30 and 60
Secondary	cerebral MRI	results of D30 control MRI, compared to baseline MRI	day 30
Secondary	medullar MRI	results of baseline medullar MRI and the link between leak and patient recovery	day 60
Secondary	Epidural Blood Patch	Volume of blood and localisation of injection / statistical data related with recovery	day 60