<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02261792</url>
  </required_header>
  <id_info>
    <org_study_id>P111118</org_study_id>
    <secondary_id>2013-AO1017-38</secondary_id>
    <nct_id>NCT02261792</nct_id>
  </id_info>
  <brief_title>Spontaneous Intracranial Hypotension Treatment &quot;SIHT&quot;</brief_title>
  <acronym>SIHT</acronym>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Spontaneous intracranial hypotension (SIH) is an infrequent disease, related to a leak of&#xD;
      cerebrospinal fluid. There are not controlled studies for this treatment.The main of this&#xD;
      study is to demonstrate the superiority of the Trendelenburg position compared to supine&#xD;
      position during 24 hours after an epidural blood patch for a spontaneous intracranial&#xD;
      hypotension&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Various treatments have been used for patient with spontaneous intracranial hypotension, but&#xD;
      there is not definite approach. Some patients, fortunately, improve spontaneously. Bed rest&#xD;
      and increased fluid intake have been advocate. The effectiveness of the caffeine has been&#xD;
      shown in some studies, but durable beneficial effect is doubtful. The efficacy of steroids&#xD;
      has not been established. However, although there have been no controlled studies, autologous&#xD;
      epidural blood patch (EBP) can be considered the treatment of choice for patients. The&#xD;
      success rate of EBP for a post lumbar puncture headache is about 90%, but for SIH, is very&#xD;
      less about 50% after the first one and 77% after the second. The amount of blood injected&#xD;
      must be sufficient. On the other hand, the leak is usually located on dorsal, above the&#xD;
      prolonged rest must be respected. One study, have demonstrated, without randomization, a&#xD;
      success rate of 90% with a prolonged Trendelenburg after EBP. We decided to do this study, to&#xD;
      confirm a superiority of a 24 hours prolonged Trendelenburg position.&#xD;
&#xD;
      It's a monocentric study of parallel randomized open blind groups. Patients will be recruited&#xD;
      by investigators in our headache emergency room. If the diagnose of SIH is confirmed&#xD;
      (orthostatic headache from more than 5 days and less than 28 days with a normal MRI or with&#xD;
      sign of SIH) study will be proposed.&#xD;
&#xD;
      After a signed information, the patients will be randomized in 2 groups, the investigator is&#xD;
      blind of the randomized arm of patient&#xD;
&#xD;
        1. EBP with 24 hours bed rest&#xD;
&#xD;
        2. EBP with 24 hours Trendelenburg position&#xD;
&#xD;
      V1: inclusion V2 : 24 hours before EBP (headache, associated symptoms, HIT6) V3 :&#xD;
      randomization and EBP V4 : first evaluation 30 minutes after standing (headaches, associated&#xD;
      symptoms) V5 : phone evaluation (safety) D7 V6 : Evaluation at D15 (headache, associated&#xD;
      symptoms, safety) V7 : Evaluation at D30 (headache, associated symptoms, control cerebral&#xD;
      MRI, HIT6, safety) V8 : last evaluation D60 (headache, associated symptoms,HIT6 safety)&#xD;
&#xD;
      Collection of 2nd EBP, 3rd EBP, 4th EBP throughout the study up to J 92 maximum&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Actual">March 8, 2021</completion_date>
  <primary_completion_date type="Actual">October 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recovery at Day 1 without relapse at Day 15</measure>
    <time_frame>Day 1</time_frame>
    <description>V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recovery at Day 1 without relapse at Day 15</measure>
    <time_frame>day 15</time_frame>
    <description>V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>2d EBP and other EBP</measure>
    <time_frame>day 7, 15, 30 and 60</time_frame>
    <description>Number of patients requires a treatment with a second BP at any time of study (withdrawal study)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Associated symptoms</measure>
    <time_frame>day 1, 15, 30 and 60</time_frame>
    <description>Disappearance of associated symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Headache</measure>
    <time_frame>day 1,15, 30 and 60</time_frame>
    <description>Pain scores, localisation and type of persistent headache at day 1,15, 30 and 60</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>subdural hematoma surgery</measure>
    <time_frame>day 7, 15, 30 and 60</time_frame>
    <description>Number of patients requires a surgery for life-threatening acute SDH</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cerebral MRI</measure>
    <time_frame>day 30</time_frame>
    <description>results of D30 control MRI, compared to baseline MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>medullar MRI</measure>
    <time_frame>day 60</time_frame>
    <description>results of baseline medullar MRI and the link between leak and patient recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epidural Blood Patch</measure>
    <time_frame>day 60</time_frame>
    <description>Volume of blood and localisation of injection / statistical data related with recovery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Spontaneous Intracranial Hypotension</condition>
  <arm_group>
    <arm_group_label>A : 24 hours bed rest</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>24 hours bed rest</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B : 24 hours Trendelenburg position</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>24 hours Trendelenburg position</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>24 hours Trendelenburg position</intervention_name>
    <description>Trendelenburg position</description>
    <arm_group_label>B : 24 hours Trendelenburg position</arm_group_label>
    <other_name>inclination of the body at 20 degrees</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>24 hours bed rest</intervention_name>
    <description>24 hours bed rest after EBP</description>
    <arm_group_label>A : 24 hours bed rest</arm_group_label>
    <other_name>Allitement flat position for 24 hours</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>EBP</intervention_name>
    <description>Autologous Epidural Blood Patch</description>
    <arm_group_label>A : 24 hours bed rest</arm_group_label>
    <arm_group_label>B : 24 hours Trendelenburg position</arm_group_label>
    <other_name>Epidural Blood Patch</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or more&#xD;
&#xD;
          -  No contraindication for BPE&#xD;
&#xD;
          -  Severe or moderate headache within 15 min standing, mild or no headache after 15 min&#xD;
             bed rest&#xD;
&#xD;
          -  Headache from 5 to 28 days&#xD;
&#xD;
          -  Normal or evidence of low CSF on MRI&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known dural leak in the previous 2 months the onset of headache&#xD;
&#xD;
          -  Abnormal MRI&#xD;
&#xD;
          -  First BPE for SIH&#xD;
&#xD;
          -  The patient has participated in another clinical trial than can interact with the&#xD;
             evaluation&#xD;
&#xD;
          -  Contraindication of Trendelenburg position&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Caroline ROOS, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lariboisiere Hospital - Centre Urgences Céphalées (CUC)</name>
      <address>
        <city>Paris</city>
        <zip>75010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>20050898</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11723293</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>April 20, 2022</last_update_submitted>
  <last_update_submitted_qc>April 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postural headache treatment</keyword>
  <keyword>Spontaneous intracranial hypotension</keyword>
  <keyword>Epidural blood patch</keyword>
  <keyword>Trendelenburg position</keyword>
  <keyword>Head-Down Tilt</keyword>
  <keyword>Blood Patch, Epidural</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intracranial Hypotension</mesh_term>
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02261792
org study id: P111118
secondary id: 2013-AO1017-38
nct id: NCT02261792
lead sponsor: 
has dmc: No
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
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Recovery at Day 1 without relapse at Day 15
time frame: Day 1
description: V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety)
measure: Recovery at Day 1 without relapse at Day 15
time frame: day 15
description: V4: first evaluation 30 minutes after standing (headaches, associated symptoms) V6 : Evaluation at D15 (headache, associated symptoms, safety)
measure: 2d EBP and other EBP
time frame: day 7, 15, 30 and 60
description: Number of patients requires a treatment with a second BP at any time of study (withdrawal study)
measure: Associated symptoms
time frame: day 1, 15, 30 and 60
description: Disappearance of associated symptoms
measure: Headache
time frame: day 1,15, 30 and 60
description: Pain scores, localisation and type of persistent headache at day 1,15, 30 and 60
measure: subdural hematoma surgery
time frame: day 7, 15, 30 and 60
description: Number of patients requires a surgery for life-threatening acute SDH
measure: cerebral MRI
time frame: day 30
description: results of D30 control MRI, compared to baseline MRI
measure: medullar MRI
time frame: day 60
description: results of baseline medullar MRI and the link between leak and patient recovery
measure: Epidural Blood Patch
time frame: day 60
description: Volume of blood and localisation of injection / statistical data related with recovery
arm group label: A : 24 hours bed rest
arm group type: Active Comparator
description: 24 hours bed rest
arm group label: B : 24 hours Trendelenburg position
arm group type: Experimental
description: 24 hours Trendelenburg position
intervention type: Procedure
intervention name: 24 hours Trendelenburg position
description: Trendelenburg position
arm group label: B : 24 hours Trendelenburg position
other name: inclination of the body at 20 degrees
intervention type: Procedure
intervention name: 24 hours bed rest
description: 24 hours bed rest after EBP
arm group label: A : 24 hours bed rest
other name: Allitement flat position for 24 hours
intervention type: Procedure
intervention name: EBP
description: Autologous Epidural Blood Patch
arm group label: A : 24 hours bed rest
arm group label: B : 24 hours Trendelenburg position
other name: Epidural Blood Patch
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Caroline ROOS, MD
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
citation: 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.
PMID: 20050898
citation: 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.
PMID: 11723293
responsible party type: Sponsor
mesh term: Intracranial Hypotension
mesh term: Hypotension