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Completed

NCT Number: NCT02261792

Spontaneous Intracranial Hypotension Treatment "SIHT"

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lariboisiere Hospital - Centre Urgences Céphalées (CUC)

Paris, 75010, France

About this study

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 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

24 hours Trendelenburg position

Procedure

Trendelenburg position

Other names: inclination of the body at 20 degrees

24 hours bed rest

Procedure

24 hours bed rest after EBP

Other names: Allitement flat position for 24 hours

EBP

Procedure

Autologous Epidural Blood Patch

Other names: Epidural Blood Patch

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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)

  2. Associated symptoms

    Time frame: day 1, 15, 30 and 60

    Disappearance of associated symptoms

  3. Headache

    Time frame: day 1,15, 30 and 60

    Pain scores, localisation and type of persistent headache at day 1,15, 30 and 60

  4. subdural hematoma surgery

    Time frame: day 7, 15, 30 and 60

    Number of patients requires a surgery for life-threatening acute SDH

  5. cerebral MRI

    Time frame: day 30

    results of D30 control MRI, compared to baseline MRI

  6. medullar MRI

    Time frame: day 60

    results of baseline medullar MRI and the link between leak and patient recovery

  7. Epidural Blood Patch

    Time frame: day 60

    Volume of blood and localisation of injection / statistical data related with recovery

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: SIHT

Important dates

Study start
2014
Primary completion
2020
Study completion
2021
First posted
Oct 10, 2014
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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