Traumatic Brain InjuryNCT03364634
Intracranial Pressure After Decompressive Craniectomy
An observational study of Traumatic Brain Injury and Middle Cerebral Artery Stroke, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
Observational study to investigate the natural course of intracranial pressure (ICP) after decompressive craniectomy (DC) using long-term telemetric ICP monitoring. Patients will have continuous ICP measurement performed during the admission to the neuro-intensive care unit (NICU) and after discharge weekly… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Middle Cerebral Artery Stroke, Intracranial Hemorrhages
- What is being tested?
- Intracranial pressure monitoring
- How many people
- 17 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 30 Jul 2017
- 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: Adult patients scheduled for a decompressive hemicraniectomy for elevated ICP (e.g. following severe traumatic brain injury) or signs of intracranial herniation (e.g. following cerebral edema in patients with middle cerebral artery infarction).
Who may be able to join
- age > 18 years
- scheduled for a decompressive hemicraniectomy for elevated ICP or signs of intracranial herniation
Who cannot join
- skin damage in the frontal area where the telemetric ICP sensor is implanted
- lack of informed consent from next-of-kin or the patient's general practitioner
About this study
Observational study to investigate the natural course of intracranial pressure (ICP) after decompressive craniectomy (DC) using long-term telemetric ICP monitoring. Patients will have continuous ICP measurement performed during the admission to the neuro-intensive care unit (NICU) and after discharge weekly measurements sessions will be performed before and after cranioplasty.
Read the detailed description
Several studies have investigated and documented the effect of DC in lowering ICP in intracranial hypertension following acute brain injuries, e.g. severe traumatic brain injury. But the natural course of ICP in these patients after the acute phase in the NICU has never been investigated. Clinical experience suggests that a DC affects cerebrospinal fluid circulation and ICP, e.g. causing hydrocephalus or subdural hygromas.
The aim of this observational study is to document the natural course of ICP following DC and to investigate the effect of cranioplasty on ICP. This is done by implantation of a telemetric ICP sensor and weekly follow-up monitoring sessions after discharge from the NICU until 1 month after cranioplasty. The monitoring sessions will include standardized body positions to investigate postural ICP changes before and after cranioplasty. The project will also provide experience with telemetric ICP monitoring during the acute phase in a NICU setting.
- Conditions
- Traumatic Brain Injury, Middle Cerebral Artery Stroke, Intracranial Hemorrhages, Intracranial Hypertension
- Being tested
- Intracranial pressure monitoring
- Keywords
- decompressive craniectomy, intracranial pressure, icp, telemetry, telemetric
- Medical subject headings
- Brain Injuries, Traumatic, Infarction, Middle Cerebral Artery, Intracranial Hemorrhages, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracranial pressure monitoringDiagnostic test
Weekly ICP monitoring sessions beginning at discharge from the neuro-intensive care unit and carried out until 1 month after cranioplasty.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial pressure variations
ICP is measured in standardized body positions to investigate postural changes after decompressive craniectomy and following cranioplasty
Measured: Weekly monitoring sessions from discharge from the neuro-intensive care unit to 1 month after cranioplasty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2017
- Study start1 Oct 2015
- Primary completion30 Jul 2017
- Study completion30 Jul 2017
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 Copenhagen University Hospital, RigshospitaletThe 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
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Lilja-Cyron, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364634
- Sponsor's protocol ID
- ICPinDCv1.1
- Other IDs
- H-15009654
- Status last verified
- Dec 2017
- First submitted
- 1 Dec 2017
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracranial Pressure After Decompressive Craniectomy
- ClinicalTrials.gov ID
- NCT03364634
- Acronym / sponsor ID
- ICPinDCv1.1
- Conditions
- Traumatic Brain Injury, Middle Cerebral Artery Stroke, Intracranial Hemorrhages, Intracranial Hypertension
- Keywords
- decompressive craniectomy, intracranial pressure, icp, telemetry, telemetric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 30 Jul 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 6 Dec 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.
Observational study to investigate the natural course of intracranial pressure (ICP) after decompressive craniectomy (DC) using long-term telemetric ICP monitoring. Patients will have continuous ICP measurement performed during the admission to the neuro-intensive care unit (NICU) and after discharge weekly measurements sessions will be performed before and after cranioplasty.
Detailed description
Several studies have investigated and documented the effect of DC in lowering ICP in intracranial hypertension following acute brain injuries, e.g. severe traumatic brain injury. But the natural course of ICP in these patients after the acute phase in the NICU has never been investigated. Clinical experience suggests that a DC affects cerebrospinal fluid circulation and ICP, e.g. causing hydrocephalus or subdural hygromas.
The aim of this observational study is to document the natural course of ICP following DC and to investigate the effect of cranioplasty on ICP. This is done by implantation of a telemetric ICP sensor and weekly follow-up monitoring sessions after discharge from the NICU until 1 month after cranioplasty. The monitoring sessions will include standardized body positions to investigate postural ICP changes before and after cranioplasty. The project will also provide experience with telemetric ICP monitoring during the acute phase in a NICU setting.
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
- Adult patients scheduled for a decompressive hemicraniectomy for elevated ICP (e.g. following severe traumatic brain injury) or signs of intracranial herniation (e.g. following cerebral edema in patients with middle cerebral artery infarction).
Key inclusion criteria (2 listed)
- age > 18 years
- scheduled for a decompressive hemicraniectomy for elevated ICP or signs of intracranial herniation
Key exclusion criteria (2 listed)
- skin damage in the frontal area where the telemetric ICP sensor is implanted
- lack of informed consent from next-of-kin or the patient's general practitioner
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 |
|---|---|---|
| Intracranial pressure monitoringWeekly ICP monitoring sessions beginning at discharge from the neuro-intensive care unit and carried out until 1 month after cranioplasty. | Diagnostic test | – |
Primary outcome
Intracranial pressure variations
Time frame: Weekly monitoring sessions from discharge from the neuro-intensive care unit to 1 month after cranioplasty
ICP is measured in standardized body positions to investigate postural changes after decompressive craniectomy and following cranioplasty
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 6 Dec 2017.
- Website of Copenhagen CSF Study GroupLink provided by the sponsor.
- Website of Rigshospitalet (Copenhagen University Hospital), where the study is carried outLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Middle Cerebral Artery Stroke, run by Copenhagen University Hospital, Rigshospitalet.
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 2 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 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Intracranial pressure variations (time frame: Weekly monitoring sessions from discharge from the neuro-intensive care unit to 1 month after cranioplasty). 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 6 Dec 2017; AzTrials last refreshed its copy on 28 Oct 2026.