Multimodal Monitoring in Patients With Spontaneous Intracerebral Hemorrhage

Cerebral Hemorrhage Clinical Trial

Official title:

Multimodal Monitoring in Patients With Spontaneous Intracerebral Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02326571
• Other study ID #: H-1-2014-059
• Status: Completed
• Phase: N/A
• First received: December 12, 2014
• Last updated: April 10, 2017
• Start date: December 2014
• Est. completion date: June 20, 2016

Study information

• Verified date: April 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 20, 2016
• Est. primary completion date: June 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage

Locations

Country	Name	City	State
Denmark	Rigshospitalet, NICU	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Christian Kærsmose Friberg

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Secondary brain injury	Assessed by GCS, CAM-ICU, mRS, Imaging, EEG background activity.	10 days