Early Multimodal Neuromonitoring Foi Spontaneous Intracerebral Hemorrhage (ICH)

• Sponsor: Universidade do Porto (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05501613
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Anticipated Duration (Months): 94
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Intracerebral Hemorrhage; Critically Ill; Intracranial Pressure; Cerebral Perfusion Pressure; Prognostic	Diagnostic Test: Multimodal Neuromonitoring

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 Design

• Study Type: Observational
• Anticipated Enrollment: 60 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Early Multimodal Neuromonitoring Parameters as Prognostic Factors For Critically Ill Spontaneous ICH Patients
• Actual Study Start Date: Jan 1, 2015
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Outcome Measures

Primary Outcome Measures

1. Survival [1 and 6 months]

   1 and 6 months survival

2. Functional Outcome [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro Hospitalar Universitário de São João	Porto		Portugal

Sponsors and Collaborators

• Universidade do Porto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ana Filipa Vaz Ferreira, Principal Investigator, Universidade do Porto
• ClinicalTrials.gov Identifier: NCT05501613
• Other Study ID Numbers: 202201
• First Posted: Aug 15, 2022
• Last Update Posted: Aug 24, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cerebral Hemorrhage; Hemorrhage; Critical Illness

Study Results

No Results Posted as of Aug 24, 2022