Traumatic Brain InjuryNCT04428970
Intracranial Pressure (ICP) Monitoring Following Traumatic Brain Injury (TBI)
An observational study of Traumatic Brain Injury, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The aim of this retrospective cohort study is to evaluate complications rates, indications, and the utility of follow-up imaging studies of ICP measurement in severe TBI patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Invasive ICP monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 214 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jan 2007to 31 Jan 2020
- 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: Patients transferred to our department after severe TBI who had received invasive ICP monitoring will be included in this study.
Who may be able to join
- Severe Traumatic Brain Injury (GCS<9 on arrival)
- Implantation of invasive intracranial parenchymal ICP monitoring
Who cannot join
- incomplete data records
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intracranial Pressure Monitoring Following Traumatic Brain Injury - Evaluation of Indications, Complications, and Significance of Follow-up Imaging.
The aim of this retrospective cohort study is to evaluate complications rates, indications, and the utility of follow-up imaging studies of ICP measurement in severe TBI patients.
- Conditions
- Traumatic Brain Injury
- Being tested
- Invasive ICP monitoring
- Keywords
- Intracranial pressure monitoring
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invasive ICP monitoringProcedure or surgery
Insertion of a parenchymal pressure measuring probe
| Study group | Role | What they receive |
|---|---|---|
| TBI patients with ICP monitoring | Patients with severe TBI (GCS<9 on arrival) receiving invasive ICP monitoring Receives: Procedure: Invasive ICP monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
Intervention-related complications
Measured: up to 30 days
Secondary outcomes (1)
Clinical outcome
Outcome at discharge measured by the Glasgow Outcome Scale (GOS), range 1(death) - 5 (good recovery)
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jan 2007
- Primary completion30 Sep 2017
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Haider, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428970
- Sponsor's protocol ID
- 2086/2019
- Status last verified
- Jan 2021
- First submitted
- 6 Jun 2020
- Last updated
- 26 Jan 2021
- 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 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracranial Pressure Monitoring Following Traumatic Brain Injury - Evaluation of Indications, Complications, and Significance of Follow-up Imaging.
- ClinicalTrials.gov ID
- NCT04428970
- Acronym / sponsor ID
- 2086/2019
- Conditions
- Traumatic Brain Injury
- Keywords
- Intracranial pressure monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 11 Jun 2020 (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.
The aim of this retrospective cohort study is to evaluate complications rates, indications, and the utility of follow-up imaging studies of ICP measurement in severe TBI patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TBI patients with ICP monitoring | – | Procedure: Invasive ICP monitoringPatients with severe TBI (GCS<9 on arrival) receiving invasive ICP monitoring |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients transferred to our department after severe TBI who had received invasive ICP monitoring will be included in this study.
Key inclusion criteria (2 listed)
- Severe Traumatic Brain Injury (GCS<9 on arrival)
- Implantation of invasive intracranial parenchymal ICP monitoring
Key exclusion criteria (1 listed)
- incomplete data records
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 |
|---|---|---|
| Invasive ICP monitoringInsertion of a parenchymal pressure measuring probe | Procedure or surgery | TBI patients with ICP monitoring |
Primary outcome
Complications
Time frame: up to 30 days
Intervention-related complications
1 secondary outcome
Clinical outcome
Time frame: up to 30 days
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 26 Jan 2021.
- 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.
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 Traumatic Brain Injury, run by Medical University of Vienna at 1 site in Austria.
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: finished, as of the sponsor's last update on 26 Jan 2021. 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 Austria. 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?
Complications (time frame: up to 30 days). 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 26 Jan 2021.