NCT02261792

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 10, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2021

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

5.8 years

First QC Date

September 26, 2014

Last Update Submit

April 20, 2022

Conditions

Spontaneous Intracranial Hypotension

Keywords

Postural headache treatmentSpontaneous intracranial hypotensionEpidural blood patchTrendelenburg positionHead-Down TiltBlood Patch, Epidural

Outcome Measures

Primary Outcomes (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)

    Day 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)

    day 15

Secondary Outcomes (7)

  • 2d EBP and other EBP

    day 7, 15, 30 and 60

  • Associated symptoms

    day 1, 15, 30 and 60

  • Headache

    day 1,15, 30 and 60

  • subdural hematoma surgery

    day 7, 15, 30 and 60

  • cerebral MRI

    day 30

  • +2 more secondary outcomes

Study Arms (2)

A : 24 hours bed rest

ACTIVE COMPARATOR

24 hours bed rest

Procedure: 24 hours bed restProcedure: EBP

B : 24 hours Trendelenburg position

EXPERIMENTAL

24 hours Trendelenburg position

Procedure: 24 hours Trendelenburg positionProcedure: EBP

Interventions

24 hours Trendelenburg positionPROCEDURE

Trendelenburg position

Also known as: inclination of the body at 20 degrees
B : 24 hours Trendelenburg position
24 hours bed restPROCEDURE

24 hours bed rest after EBP

Also known as: Allitement flat position for 24 hours
A : 24 hours bed rest
EBPPROCEDURE

Autologous Epidural Blood Patch

Also known as: Epidural Blood Patch
A : 24 hours bed restB : 24 hours Trendelenburg position

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lariboisiere Hospital - Centre Urgences Céphalées (CUC)

Paris, 75010, France

Location

Related Publications (2)

  • 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: 20050898BACKGROUND

  • 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: 11723293BACKGROUND

MeSH Terms

Conditions

Intracranial Hypotension

Interventions

Head-Down TiltBed RestBlood Patch, Epidural

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaTherapeuticsBiological TherapyInjections, EpiduralInjections, SpinalInjectionsDrug Administration RoutesDrug Therapy

Study Officials

  • Caroline ROOS, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2014

First Posted

October 10, 2014

Study Start

December 1, 2014

Primary Completion

October 1, 2020

Study Completion

March 8, 2021

Last Updated

April 21, 2022

Record last verified: 2022-04

Locations

FR(1)