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Trial record 14 of 66 for:    "cerebral autosomal recessive arteriopathy with subcortical infarcts and leukoencephalopathy" OR "Cerebral Arterial Diseases"

Intracranial Pressure After Decompressive Craniectomy

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ClinicalTrials.gov Identifier: NCT03364634
Recruitment Status : Completed
First Posted : December 6, 2017
Last Update Posted : December 6, 2017
Sponsor:
Information provided by (Responsible Party):
Alexander Lilja-Cyron, Rigshospitalet, Denmark

Brief 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 measurements sessions will be performed before and after cranioplasty.

Condition or disease Intervention/treatment
Traumatic Brain Injury Middle Cerebral Artery Stroke Intracranial Hemorrhages Intracranial Hypertension Diagnostic Test: Intracranial pressure monitoring

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 Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intracranial Pressure After Decompressive Craniectomy
Actual Study Start Date : October 1, 2015
Actual Primary Completion Date : July 30, 2017
Actual Study Completion Date : July 30, 2017

Intervention Details:
  • Diagnostic Test: Intracranial pressure monitoring
    Weekly ICP monitoring sessions beginning at discharge from the neuro-intensive care unit and carried out until 1 month after cranioplasty.


Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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).
Criteria

Inclusion Criteria:

  • age > 18 years
  • scheduled for a decompressive hemicraniectomy for elevated ICP or signs of intracranial herniation

Exclusion Criteria:

  • 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

Additional Information:
Responsible Party: Alexander Lilja-Cyron, MD, PhD fellow, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03364634     History of Changes
Other Study ID Numbers: ICPinDCv1.1
H-15009654 ( Other Identifier: The Regional Committee on Health Research Ethics )
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexander Lilja-Cyron, Rigshospitalet, Denmark:
decompressive craniectomy
intracranial pressure
icp
telemetry
telemetric

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Brain Injuries
Hemorrhage
Brain Injuries, Traumatic
Intracranial Hemorrhages
Intracranial Hypertension
Infarction, Middle Cerebral Artery
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Pathologic Processes
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Cerebral Infarction
Brain Infarction
Brain Ischemia
Intracranial Arterial Diseases
Stroke