Head InjuryNCT03164434
Influence of Drainage on EVD ICP-signal
An observational study of Head Injury and Subarachnoid Hemorrhage, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This observational study investigates ICP signals obtained through an external ventricular drain in the brain connected with an external transducer. In particular, the study investigates how drainage influences the monitored signal: influence of flow rate, reservoir height and initial ICP before draining. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Head Injury, Subarachnoid Hemorrhage
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2014to May 2016
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe traumatic brain injury or subarachnoid hemorrhage in whom monitoring of ICP is warranted.
Who may be able to join
- TBI/SAH patients with need for ICP monitoring
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Drainage of Cerebrospinal Fluid on ICP Signals Obtained Through an External Ventricular Drain.
This observational study investigates ICP signals obtained through an external ventricular drain in the brain connected with an external transducer. In particular, the study investigates how drainage influences the monitored signal: influence of flow rate, reservoir height and initial ICP before draining.
- Conditions
- Head Injury, Subarachnoid Hemorrhage
- Keywords
- intracranial pressure, cerebrospinal fluid drainage, waveform analysis
- Medical subject headings
- Craniocerebral Trauma, Subarachnoid Hemorrhage, Cerebrospinal Fluid Leak
What is being measured
The primary outcome is the main question the study is designed to answer.
ICP signal changes
changes in magnitude and amplitude of ICP pulse during drainage of CSF
Measured: immediate during drainage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study startSep 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head InjuryStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. dr. Bart Depreitere, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Bart Depreitere, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03164434
- Sponsor's protocol ID
- EVD-ICP
- Status last verified
- Dec 2022
- First submitted
- 21 May 2017
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Drainage of Cerebrospinal Fluid on ICP Signals Obtained Through an External Ventricular Drain.
- ClinicalTrials.gov ID
- NCT03164434
- Acronym / sponsor ID
- EVD-ICP
- Conditions
- Head Injury, Subarachnoid Hemorrhage
- Keywords
- intracranial pressure, cerebrospinal fluid drainage, waveform analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 23 May 2017 (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.
This observational study investigates ICP signals obtained through an external ventricular drain in the brain connected with an external transducer. In particular, the study investigates how drainage influences the monitored signal: influence of flow rate, reservoir height and initial ICP before draining.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe traumatic brain injury or subarachnoid hemorrhage in whom monitoring of ICP is warranted.
Key inclusion criteria (1 listed)
- TBI/SAH patients with need for ICP monitoring
Key exclusion criteria (1 listed)
- -
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
ICP signal changes
Time frame: immediate during drainage
changes in magnitude and amplitude of ICP pulse during drainage of CSF
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 21 Dec 2022.
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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.
Bart Depreitere, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
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 Head Injury and Subarachnoid Hemorrhage, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 1 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: finished, as of the sponsor's last update on 21 Dec 2022. 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 Belgium. 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?
ICP signal changes (time frame: immediate during drainage). 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 21 Dec 2022.