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Spontaneous Intracranial Hypotension Treatment "SIHT" (SIHT)

This study is currently recruiting participants.
Verified December 2016 by Assistance Publique - Hôpitaux de Paris
Sponsor:
ClinicalTrials.gov Identifier:
NCT02261792
First Posted: October 10, 2014
Last Update Posted: January 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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

Condition Intervention
Spontaneous Intracranial Hypotension Procedure: 24 hours Trendelenburg position Procedure: 24 hours bed rest Procedure: EBP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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)

  • 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 Outcome Measures:
  • 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)

  • Associated symptoms [ Time Frame: day 1, 15, 30 and 60 ]
    Disappearance of associated symptoms

  • Headache [ Time Frame: day 1,15, 30 and 60 ]
    Pain scores, localisation and type of persistent headache at day 1,15, 30 and 60

  • subdural hematoma surgery [ Time Frame: day 7, 15, 30 and 60 ]
    Number of patients requires a surgery for life-threatening acute SDH

  • cerebral MRI [ Time Frame: day 30 ]
    results of D30 control MRI, compared to baseline MRI

  • medullar MRI [ Time Frame: day 60 ]
    results of baseline medullar MRI and the link between leak and patient recovery

  • Epidural Blood Patch [ Time Frame: day 60 ]
    Volume of blood and localisation of injection / statistical data related with recovery


Estimated Enrollment: 66
Study Start Date: December 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A : 24 hours bed rest
24 hours bed rest
Procedure: 24 hours bed rest
24 hours bed rest after EBP
Other Name: Allitement flat position for 24 hours
Procedure: EBP
Autologous Epidural Blood Patch
Other Name: Epidural Blood Patch
Experimental: B : 24 hours Trendelenburg position
24 hours Trendelenburg position
Procedure: 24 hours Trendelenburg position
Trendelenburg position
Other Name: inclination of the body at 20 degrees
Procedure: EBP
Autologous Epidural Blood Patch
Other Name: Epidural Blood Patch

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02261792


Contacts
Contact: Caroline Roos ROOS, MD 33 (0)1 49956537 / 2484 caroline.roos@lrb.aphp.fr

Locations
France
Lariboisiere Hospital - Centre Urgences Céphalées (CUC) Recruiting
Paris, France, 75010
Principal Investigator: Caroline ROOS, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Caroline ROOS, MD Assistance Publique - Hôpitaux de Paris
  More Information

Publications:
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02261792     History of Changes
Other Study ID Numbers: P111118
2013-AO1017-38 ( Other Identifier: IDRCB )
First Submitted: September 26, 2014
First Posted: October 10, 2014
Last Update Posted: January 4, 2017
Last Verified: December 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Postural headache treatment
Spontaneous intracranial hypotension
Epidural blood patch
Trendelenburg position
Head-Down Tilt
Blood Patch, Epidural

Additional relevant MeSH terms:
Hypotension
Intracranial Hypotension
Vascular Diseases
Cardiovascular Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases