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Spontaneous Intracranial HypotensionSIHTNCT02261792

Spontaneous Intracranial Hypotension Treatment "SIHT"

A study testing 24 hours Trendelenburg position, 24 hours bed rest and EBP in people with Spontaneous Intracranial Hypotension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spontaneous Intracranial Hypotension
What is being tested?
24 hours Trendelenburg position, 24 hours bed rest and EBP
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteFrance
Study dates
Dec 2014to 8 Mar 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Lariboisiere Hospital - Centre Urgences Céphalées (CUC)

    Paris, 75010

Other trials in France

About this study

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

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

Read the 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

Being tested
24 hours Trendelenburg position, 24 hours bed rest, EBP
Keywords
Postural headache treatment, Spontaneous intracranial hypotension, Epidural blood patch, Trendelenburg position, Head-Down Tilt, Blood Patch, Epidural
Medical subject headings
Intracranial Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 24 hours Trendelenburg positionProcedure or surgery

    Also called inclination of the body at 20 degrees

    Trendelenburg position

  • 24 hours bed restProcedure or surgery

    Also called Allitement flat position for 24 hours

    24 hours bed rest after EBP

  • EBPProcedure or surgery

    Also called Epidural Blood Patch

    Autologous Epidural Blood Patch

Study groups in NCT02261792
Study groupRoleWhat they receive
A : 24 hours bed restActive comparator24 hours bed rest
Receives: Procedure: 24 hours bed rest; Procedure: EBP
B : 24 hours Trendelenburg positionExperimental24 hours Trendelenburg position
Receives: Procedure: 24 hours Trendelenburg position; Procedure: EBP

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Day 1

  2. 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)

    Measured: day 15

Secondary outcomes (7)

  1. 2d EBP and other EBP

    Number of patients requires a treatment with a second BP at any time of study (withdrawal study)

    Measured: day 7, 15, 30 and 60

  2. Associated symptoms

    Disappearance of associated symptoms

    Measured: day 1, 15, 30 and 60

  3. Headache

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

    Measured: day 1,15, 30 and 60

  4. subdural hematoma surgery

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

    Measured: day 7, 15, 30 and 60

  5. cerebral MRI

    results of D30 control MRI, compared to baseline MRI

    Measured: day 30

  6. medullar MRI

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

    Measured: day 60

  7. Epidural Blood Patch

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

    Measured: day 60

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionOct 2020
  4. Study completion8 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02261792
Sponsor's protocol ID
P111118
Other IDs
2013-AO1017-38
Acronym
SIHT
Status last verified
Apr 2022
First submitted
26 Sep 2014
Last updated
21 Apr 2022
Results posted
No
Data monitoring committee
No

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.

    PubMed 20050898

  • 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.

    PubMed 11723293

Questions about this trial

What is this clinical trial studying?

A study testing 24 hours Trendelenburg position, 24 hours bed rest and EBP in people with Spontaneous Intracranial Hypotension, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recovery at Day 1 without relapse at Day 15 (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02261792, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.

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