Intracranial HypotensionBPIHNCT06498804
The Blood Patch in the Management of Intracranial Hypotension
An observational study of Intracranial Hypotension, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hypotension
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 5 Sep 2023to 5 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major subject (≥18 years old) having benefited from a bloodpatch between 01/01/2021 and 12/31/2022
Who may be able to join
- Major subject (≥18 years old)
- Subject having benefited from a bloodpatch between 01/01/2021 and 12/31/2022
Who cannot join
- Subject (and/or their legal representative if applicable) having expressed their (their) opposition to the reuse of their data for scientific research purposes
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service d'Anesthésie Réanimation médecine Péri-Opératoire - CHU de Strasbourg - France
Strasbourg, 67091
Stefanie KOESSLER, MD, 33 3 88 12 70 90, stefanie.koessler@chru-strasbourg.fr
Stefanie KOESSLER, MD
About this study
Official title: The Blood Patch in the Management of Intracranial Hypotension: Description of a Population and Professional Practices
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.
- Conditions
- Intracranial Hypotension
- Keywords
- Intracranial Hypotension, post-dural puncture headache, cranial nerve symptoms, hearing disturbances, vertigo
- Medical subject headings
- Intracranial Hypotension, Post-Dural Puncture Headache, Vertigo
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start5 Sep 2023
- Primary completionDec 2024 (estimated)
- Study completion5 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial HypotensionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06498804
- Sponsor's protocol ID
- 9059
- Acronym
- BPIH
- Status last verified
- Apr 2024
- First submitted
- 4 Apr 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Blood Patch in the Management of Intracranial Hypotension: Description of a Population and Professional Practices
- ClinicalTrials.gov ID
- NCT06498804
- Acronym / sponsor ID
- BPIH / 9059
- Conditions
- Intracranial Hypotension
- Keywords
- Intracranial Hypotension, post-dural puncture headache, cranial nerve symptoms, hearing disturbances, vertigo
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- 5 Dec 2024 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major subject (≥18 years old) having benefited from a bloodpatch between 01/01/2021 and 12/31/2022
Key inclusion criteria (2 listed)
- Major subject (≥18 years old)
- Subject having benefited from a bloodpatch between 01/01/2021 and 12/31/2022
Key exclusion criteria (1 listed)
- Subject (and/or their legal representative if applicable) having expressed their (their) opposition to the reuse of their data for scientific research purposes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Descriptions of professional practices in the management of intracranial hypotension by blood patch at the University Hospitals of Strasbourg
Time frame: Through study completion, an average of 2 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hypotension, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefanie KOESSLER, MD (33 3 88 12 70 90, stefanie.koessler@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptions of professional practices in the management of intracranial hypotension by blood patch at the University Hospitals of Strasbourg (time frame: Through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.