The Blood Patch in the Management of Intracranial Hypotension

NCT ID: NCT06498804

Last Updated: 2024-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-05

Study Completion Date

2024-12-05

Brief Summary

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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.

Detailed Description

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Conditions

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Intracranial Hypotension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Strasbourg, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Stefanie KOESSLER, MD

Role: CONTACT

33 3 88 12 70 90

Facility Contacts

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Stefanie KOESSLER, MD

Role: primary

33 3 88 12 70 90

Other Identifiers

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9059

Identifier Type: -

Identifier Source: org_study_id

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