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Multimodal Monitoring in Patients With Spontaneous Intracerebral Hemorrhage

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ClinicalTrials.gov Identifier: NCT02326571
Recruitment Status : Completed
First Posted : December 29, 2014
Last Update Posted : April 11, 2017
Sponsor:
Information provided by (Responsible Party):
Christian Kærsmose Friberg, Rigshospitalet, Denmark

Brief Summary:

Spontaneous intracerebral bleeding also known as spontaneous intracerebral hemorrhage (sICH) constitute 10-15 % of all apoplexies. The Prognosis is considerably worse than it is for the larger population of patients suffering from cerebral thrombosis. Development of brain edema seemingly contributes to the disadvantageous prognosis. However, the mechanisms behind is only understood fragmentarily.

By using multimodal neuro monitoring, the investigators seek to investigate electrophysiological and metabolic processes, which seem to accompany the formation of edema and clinical deterioration in patients suffering from sICH.


Condition or disease
Cerebral Hemorrhage

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Study Type : Observational
Actual Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multimodal Monitoring in Patients With Spontaneous Intracerebral Hemorrhage
Study Start Date : December 2014
Actual Primary Completion Date : June 20, 2016
Actual Study Completion Date : June 20, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort
spontaneous intracerebral hemorrhage



Primary Outcome Measures :
  1. Secondary brain injury [ Time Frame: 10 days ]
    Assessed by GCS, CAM-ICU, mRS, Imaging, EEG background activity.


Biospecimen Retention:   Samples Without DNA
For later miRNA analysis.


Information from the National Library of Medicine

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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:   Non-Probability Sample
Study Population
Patients eligible for neuro surgery admitted to Rigshospitalet, Copenhagen with spontaneous intracerebral hemorrhage verified by CT.
Criteria

Inclusion Criteria:

  • Diagnosis: spontaneous intracerebral hemorrhage verified by CT
  • Clinical indication for craniotomy or craniectomy
  • Admitted to the hospital within 24 hours from assumed ictus
  • Age over 18 years

Exclusion Criteria:

  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326571


Locations
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Denmark
Rigshospitalet, NICU
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Christian Kærsmose Friberg
Investigators
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Principal Investigator: Christian K Friberg, MD

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Responsible Party: Christian Kærsmose Friberg, MD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02326571     History of Changes
Other Study ID Numbers: H-1-2014-059
First Posted: December 29, 2014    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017

Keywords provided by Christian Kærsmose Friberg, Rigshospitalet, Denmark:
EEG
Cortical Spreading Depression
Cerebral Hemorrhage
miRNA
Reactivity in EEG
Multimodal monitoring

Additional relevant MeSH terms:
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Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases