Spontaneous Intracranial Hypotension Treatment "SIHT"

NCT ID: NCT02261792

Last Updated: 2022-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2021-03-08

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 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

Conditions

Spontaneous Intracranial Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A : 24 hours bed rest

24 hours bed rest

Group Type: ACTIVE_COMPARATOR

24 hours bed rest

Intervention Type: PROCEDURE

24 hours bed rest after EBP

EBP

Intervention Type: PROCEDURE

Autologous Epidural Blood Patch

B : 24 hours Trendelenburg position

24 hours Trendelenburg position

Group Type: EXPERIMENTAL

24 hours Trendelenburg position

Intervention Type: PROCEDURE

Trendelenburg position

EBP

Intervention Type: PROCEDURE

Autologous Epidural Blood Patch

Interventions

24 hours Trendelenburg position

Trendelenburg position

Intervention Type: PROCEDURE

24 hours bed rest

24 hours bed rest after EBP

Intervention Type: PROCEDURE

EBP

Autologous Epidural Blood Patch

Intervention Type: PROCEDURE

Other Intervention Names

inclination of the body at 20 degrees; Allitement flat position for 24 hours; Epidural Blood Patch

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline ROOS, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Lariboisiere Hospital - Centre Urgences Céphalées (CUC)

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 20050898 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11723293 (View on PubMed)

Other Identifiers

2013-AO1017-38

Identifier Type: OTHER

Identifier Source: secondary_id

P111118

Identifier Type: -

Identifier Source: org_study_id