Brain DamageCLAMPNCT03823430
Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?
An observational study of Brain Damage and External Ventricular Drain, run by Association Pro-arte at 2 sites in France.
Trial summary
Pupillar diameter variation to predict success or failure of external ventricular derivation clamping. Pupillometry utilisation as a diagnostic tool in external ventricular clamping test in neurological ICU should improve patients care in several ways : earlier use of ventriculo-peritoneal or ventriculo-atrial shunts… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Damage, External Ventricular Drain, Hydrocephalus
- What is being tested?
- Pupillometry
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- 11 Jul 2018to 11 Mar 2021
- 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: Any patient with an external ventricular drain in neurologic ICU can be recruited in the study if all the eligibility criteria are met.
Who may be able to join
- Neurologic ICU hospitalization
- Traumatic brain injury
- External ventricular drain
Who cannot join
- Legal protection
- refusal
- therapeutics limitation
- craniectomy
- pupillar anomaly
Trial locations and contacts
2 sites in 1 country.
About this study
Pupillar diameter variation to predict success or failure of external ventricular derivation clamping.
Pupillometry utilisation as a diagnostic tool in external ventricular clamping test in neurological ICU should improve patients care in several ways :
- earlier use of ventriculo-peritoneal or ventriculo-atrial shunts to shorten the external ventricular treatment duration and thus reduce risks of infection and hospital stay duration
- limit the medical imagery prescription and radiation exposition
- avoid neurological deterioration linked to the external ventricular drain clamping in case of the pupillometric parameters variation would be earlier than clinical signs
- Conditions
- Brain Damage, External Ventricular Drain, Hydrocephalus
- Being tested
- Pupillometry
- Medical subject headings
- Brain Injuries, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PupillometryDiagnostic test
Pupillar diameter variation measurement
What is being measured
The primary outcome is the main question the study is designed to answer.
Pupillar diameter variation to predict success or failure of external ventricular clamping
Pupillar diameter variation twenty-four hours after external ventricular drain clamping
Measured: 24 hours after clamping
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start11 Jul 2018
- Primary completion2 Jan 2021
- Study completion11 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DamageStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Pro-arte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03823430
- Sponsor's protocol ID
- 3-2018-CLAMP
- Acronym
- CLAMP
- Status last verified
- Feb 2022
- First submitted
- 4 Jan 2019
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pupillometry : Predictive Indicator in External Ventricular Drain Clamping ?
- ClinicalTrials.gov ID
- NCT03823430
- Acronym / sponsor ID
- CLAMP / 3-2018-CLAMP
- Conditions
- Brain Damage, External Ventricular Drain, Hydrocephalus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Association Pro-arteUniversity, hospital or other
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 2 Jan 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 30 Jan 2019 (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.
Pupillar diameter variation to predict success or failure of external ventricular derivation clamping.
Pupillometry utilisation as a diagnostic tool in external ventricular clamping test in neurological ICU should improve patients care in several ways :
- earlier use of ventriculo-peritoneal or ventriculo-atrial shunts to shorten the external ventricular treatment duration and thus reduce risks of infection and hospital stay duration
- limit the medical imagery prescription and radiation exposition
- avoid neurological deterioration linked to the external ventricular drain clamping in case of the pupillometric parameters variation would be earlier than clinical signs
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient with an external ventricular drain in neurologic ICU can be recruited in the study if all the eligibility criteria are met.
Key inclusion criteria (3 listed)
- Neurologic ICU hospitalization
- Traumatic brain injury
- External ventricular drain
Key exclusion criteria (5 listed)
- Legal protection
- refusal
- therapeutics limitation
- craniectomy
- pupillar anomaly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PupillometryPupillar diameter variation measurement | Diagnostic test | – |
Primary outcome
Pupillar diameter variation to predict success or failure of external ventricular clamping
Time frame: 24 hours after clamping
Pupillar diameter variation twenty-four hours after external ventricular drain clamping
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Damage and External Ventricular Drain, run by Association Pro-arte at 2 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pupillar diameter variation to predict success or failure of external ventricular clamping (time frame: 24 hours after clamping). 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 16 Feb 2022.