NCT02326571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2014

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 29, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2016

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

December 12, 2014

Last Update Submit

April 10, 2017

Conditions

Cerebral Hemorrhage

Keywords

EEGCortical Spreading DepressionCerebral HemorrhagemiRNAReactivity in EEGMultimodal monitoring

Outcome Measures

Primary Outcomes (1)

  • Secondary brain injury

    Assessed by GCS, CAM-ICU, mRS, Imaging, EEG background activity.

    10 days

Study Arms (1)

spontaneous intracerebral hemorrhage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients eligible for neuro surgery admitted to Rigshospitalet, Copenhagen with spontaneous intracerebral hemorrhage verified by CT.

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, NICU

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

For later miRNA analysis.

MeSH Terms

Conditions

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christian K Friberg, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

December 12, 2014

First Posted

December 29, 2014

Study Start

December 1, 2014

Primary Completion

June 20, 2016

Study Completion

June 20, 2016

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

DK(1)