NCT06498804

Brief Summary

Intracranial hypotension results from leakage and/or hypotension of cerebrospinal fluid. It can be spontaneous or secondary to a dural puncture complicating perimedullary anesthesia or a lumbar puncture. The incidence remains low with less than 1% post spinal puncture (25 gauge needle), but is observed more frequently following a lumbar puncture, up to 36% with a 20 or 22 gauge needle. Accidental puncture of the dura mater with a 17 gauge needle used for epidural anesthesia is associated with postpuncture headaches in 75-80% of cases. Classically, symptoms appear 24 to 48 hours after the puncture and consist of very intense, postural, fronto-occipital headaches which may be associated with cranial nerve symptoms such as visual or hearing disturbances or vertigo. Among the risk factors are the size and type of the needle, age under 60 and female gender. About 90% of PDPH are self-limiting within 7-10 days.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

September 5, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2024

Completed
Last Updated

July 12, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

April 4, 2024

Last Update Submit

July 4, 2024

Conditions

Keywords

Intracranial Hypotensionpost-dural puncture headachecranial nerve symptomshearing disturbancesvertigo

Outcome Measures

Primary Outcomes (1)

  • Descriptions of professional practices in the management of intracranial hypotension by blood patch at the University Hospitals of Strasbourg

    This retrospective study focuses on the description of the practices of doctors at the Strasbourg University Hospital in the management of intracranial hypotension by blood patch.

    Through study completion, an average of 2 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Major subject (≥18 years old) having benefited from a bloodpatch between 01/01/2021 and 12/31/2022

You may qualify if:

  • Major subject (≥18 years old)
  • Subject having benefited from a bloodpatch between 01/01/2021 and 12/31/2022

You may not qualify if:

  • \- Subject (and/or their legal representative if applicable) having expressed their (their) opposition to the reuse of their data for scientific research purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Anesthésie Réanimation médecine Péri-Opératoire - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Intracranial HypotensionPost-Dural Puncture HeadacheVertigo

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeadache Disorders, SecondaryHeadache DisordersVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2024

First Posted

July 12, 2024

Study Start

September 5, 2023

Primary Completion

December 1, 2024

Study Completion

December 5, 2024

Last Updated

July 12, 2024

Record last verified: 2024-04

Locations