Multimodal Brain Monitoring as a Prognostic Tool for Intracerebral Hemorrhage

Intracerebral Hemorrhage Clinical Trial

Official title:

Multimodal Brain Monitoring as a Prognostic Tool for Intracerebral Hemorrhage - A Prospective Observational Cohort Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05771662
• Other study ID #: ICH-NEUROICU
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2023
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

To verify if there is an association between advanced multimodal brain monitoring parameters in the first 48h and fist 7 days of admission with intrahospital and six-months functional outcome, even when controlled to other factors that may influence the outcome. Secondary Goals: To describe multimodal neuromonitoring parameters variation in the first seven days of ICH and identify any trends.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: September 30, 2023
• Est. primary completion date: March 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Spontaneous Intracerebral Hemorrhage

• ICU admission in the first 24hours

• Need for intraparenchymal Neuromonitoring

• Over 18 years old

Exclusion Criteria:

• Tumour, Trauma or known Vascular Lesion

• Pregnancy

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Locations

Country	Name	City	State
Portugal	Centro Hospitalar São João	Porto

Sponsors (1)

Lead Sponsor	Collaborator
Universidade do Porto

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relation between multimodal brain monitoring parameters and outcome.	Association between advanced multimodal brain monitoring parameters of the first 48h of admission and six months functional outcome (Glasgow Outcome Score Extended)	6 months
Secondary	ICH Neuromonitoring Pattern.	Describe multimodal neuromonitoring parameters variation in the first seven days of ICH and identify trends.	7 days
Secondary	ICH Neuromonitoring and Short Term Outcome	Association between advanced multimodal brain monitoring parameters and 28 days functional outcome (Glasgow Outcome Score Extended)	28 days