Spontaneous Intracranial Hypotension Treatment "SIHT" (SIHT)

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

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

Study Overview

• Status: Completed
• Conditions: Spontaneous Intracranial Hypotension
• Intervention / Treatment: Procedure: 24 hours bed rest; Procedure: EBP; Procedure: 24 hours Trendelenburg position

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Lariboisiere Hospital - Centre Urgences Céphalées (CUC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A : 24 hours bed rest; 24 hours bed rest	Procedure: 24 hours bed rest; 24 hours bed rest after EBP; Other Names: Allitement flat position for 24 hours; Procedure: EBP; Autologous Epidural Blood Patch; Other Names: Epidural Blood Patch
Experimental: B : 24 hours Trendelenburg position; 24 hours Trendelenburg position	Procedure: EBP; Autologous Epidural Blood Patch; Other Names: Epidural Blood Patch; Procedure: 24 hours Trendelenburg position; Trendelenburg position; Other Names: inclination of the body at 20 degrees

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Associated symptoms	Disappearance of associated symptoms	day 1, 15, 30 and 60
Headache	Pain scores, localisation and type of persistent headache at day 1,15, 30 and 60	day 1,15, 30 and 60
subdural hematoma surgery	Number of patients requires a surgery for life-threatening acute SDH	day 7, 15, 30 and 60
cerebral MRI	results of D30 control MRI, compared to baseline MRI	day 30
medullar MRI	results of baseline medullar MRI and the link between leak and patient recovery	day 60
Epidural Blood Patch	Volume of blood and localisation of injection / statistical data related with recovery	day 60

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Caroline ROOS, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): October 1, 2020
• Study Completion (Actual): March 8, 2021

Study Registration Dates

• First Submitted: September 26, 2014
• First Submitted That Met QC Criteria: October 7, 2014
• First Posted (Estimate): October 10, 2014

Study Record Updates

• Last Update Posted (Actual): April 21, 2022
• Last Update Submitted That Met QC Criteria: April 20, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Trendelenburg position; Postural headache treatment; Spontaneous intracranial hypotension; Epidural blood patch; Head-Down Tilt; Blood Patch, Epidural
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypotension; Intracranial Hypotension
• Other Study ID Numbers: P111118; 2013-AO1017-38 (Other Identifier: IDRCB)