Intracranial Pressure After Decompressive Craniectomy

Intracranial Pressure After Decompressive Craniectomy



Sponsors


Source

Rigshospitalet, Denmark

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


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.

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.

Overall Status

Completed

Start Date

2015-10-01

Completion Date

2017-07-30

Primary Completion Date

2017-07-30

Phase

N/A

Study Type

Observational

Primary Outcome

Measure

Time Frame

Intracranial pressure variations
Weekly monitoring sessions from discharge from the neuro-intensive care unit to 1 month after cranioplasty

Number Of Groups

1

Enrollment

17

Conditions


Intervention

Intervention Type

Diagnostic Test

Intervention Name


Description

Weekly ICP monitoring sessions beginning at discharge from the neuro-intensive care unit and carried out until 1 month after cranioplasty.


Eligibility

Study Pop

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).

Sampling Method

Probability Sample

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

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Verification Date

2017-12-01

Lastchanged Date

2017-12-01

Firstreceived Date

2017-12-01

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Rigshospitalet, Denmark

Investigator Full Name

Alexander Lilja-Cyron

Investigator Title

MD, PhD fellow


Keywords


Has Expanded Access

No

Condition Browse


Secondary Id

H-15009654

Firstreceived Results Date

N/A

Firstreceived Results Disposition Date

N/A

Study Design Info

Observational Model

Cohort

Time Perspective

Prospective


Study First Submitted

December 1, 2017

Study First Submitted Qc

December 1, 2017

Study First Posted

December 6, 2017

Last Update Submitted

December 1, 2017

Last Update Submitted Qc

December 1, 2017

Last Update Posted

December 6, 2017


ClinicalTrials.gov processed this data on December 06, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



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