An observational study in Traumatic Brain Injury, Middle Cerebral Artery Stroke and Intracranial Hemorrhages, sponsored by Rigshospitalet, Denmark. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-06.
Sponsored by Rigshospitalet, Denmark · Observational
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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.
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.
1,722 studies on the registry are indexed under Brain Injuries, Traumatic; 448 are open to participants now.
This study's enrollment of 17 is below the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →Rigshospitalet, Denmark is the lead sponsor of 1,006 studies on the registry; 174 are open to participants now.
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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).
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weekly ICP monitoring sessions beginning at discharge from the neuro-intensive care unit and carried out until 1 month after cranioplasty.
Intracranial pressure variations
ICP is measured in standardized body positions to investigate postural changes after decompressive craniectomy and following cranioplasty
Time frame: Weekly monitoring sessions from discharge from the neuro-intensive care unit to 1 month after cranioplasty
No study locations are listed for this record.
Plan to share: Undecided
Ran from Oct 2015 to primary completion in Jul 2017, 21 months.
Of 228 non-industry observational studies under Brain Injuries, Traumatic, half reached primary completion within 50 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 95. This study's 21 months is below that.
Counting every sponsor, half of 250 studies reached it within 49 months; a quarter within 23 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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