Early Multimodal Neuromonitoring For Spontaneous Intracerebral Hemorrhage (ICH)

February 2, 2023 updated by: Ana Filipa Vaz Ferreira, Universidade do Porto

Early Multimodal Neuromonitoring Parameters as Prognostic Factors For Critically Ill Spontaneous ICH Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Retrospective observational study based on analyzing the first 48 hours of the multimodal neuromonitoring signal, from spontaneous ICH patients, whose treatment includes invasive intraparenchymal neuromonitoring, treated from January 2015 to September 2021 in a tertiary hospital.

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Porto, Portugal
        • Centro Hospitalar Universitário de São João

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Critically Ill Spontaneous Intracerebral Hemorrhage Patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival
Time Frame: 1 and 6 months
1 and 6 months survival
1 and 6 months
Functional Outcome
Time Frame: 6 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade do Porto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

October 1, 2022

Study Completion (ACTUAL)

February 1, 2023

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

August 11, 2022

First Posted (ACTUAL)

August 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 2, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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