NCT05771662

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 16, 2023

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

March 16, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

February 8, 2023

Last Update Submit

March 14, 2023

Conditions

Intracerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • ICH Neuromonitoring Pattern.

    7 days

  • ICH Neuromonitoring and Short Term Outcome

    28 days

Eligibility Criteria

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

Critically Ill, Spontaneous Intracerebral Hemorrhage Adult Patients.

You may qualify if:

  • Spontaneous Intracerebral Hemorrhage
  • ICU admission in the first 24hours
  • Need for intraparenchymal Neuromonitoring
  • Over 18 years old

You may not qualify if:

  • Tumour, Trauma or known Vascular Lesion
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar São João

Porto, Portugal

RECRUITING

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 Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2023

First Posted

March 16, 2023

Study Start

April 1, 2021

Primary Completion

March 31, 2023

Study Completion

September 30, 2023

Last Updated

March 16, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)