NCT05501613

Brief Summary

The investigators intend to assess the predictive value of early (first 48 hours) multimodal neuromonitoring parameters concerning late survival in critically ill intracerebral hemorrhage (ICH) patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

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

January 1, 2015

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

7.8 years

First QC Date

August 11, 2022

Last Update Submit

February 2, 2023

Conditions

Intracerebral HemorrhageCritically IllIntracranial PressureCerebral Perfusion PressurePrognostic

Outcome Measures

Primary Outcomes (2)

  • Survival

    1 and 6 months survival

    1 and 6 months

  • Functional Outcome

    6 month functional outcome with Modified Rankin Scale - 0 (No symptoms); 1 (No significant disability); 2 (Slight disability); 3 (Moderate disability); 4 (Moderately Severe Disability); 5 (Severe Disability); 6 (Dead).

    6 month

Interventions

Multimodal NeuromonitoringDIAGNOSTIC_TEST

Invasive Multimodal Neuromonitoring

Eligibility Criteria

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

Critically Ill Spontaneous Intracerebral Hemorrhage Patients

You may qualify if:

  • Spontaneous Intracerebral Hemorrhage
  • ICU admission
  • Need of Sedation and Ventilatory Support
  • Need of Intracerebral Neuromonitoring

You may not qualify if:

  • Etiology for Intracerebral hemorrhage such as tumor, vascular malformation, ischemic transformation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Hospitalar Universitário de São João

Porto, Portugal

Location

MeSH Terms

Conditions

Cerebral HemorrhageCritical Illness

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 11, 2022

First Posted

August 15, 2022

Study Start

January 1, 2015

Primary Completion

October 1, 2022

Study Completion

February 1, 2023

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations

PT(1)