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Spontaneous Intracranial Hypotension Treatment "SIHT"

NCT02261792 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-04-21

No results posted yet for this study

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

Conditions

  • Spontaneous Intracranial Hypotension

Interventions

PROCEDURE

24 hours Trendelenburg position

Trendelenburg position

PROCEDURE

24 hours bed rest

24 hours bed rest after EBP

PROCEDURE

EBP

Autologous Epidural Blood Patch

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Caroline ROOS, MD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2020-10-31
Completion
2021-03-08

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02261792 on ClinicalTrials.gov