Interventional Study for Detection of Prognosis of Blood Based Biomarkers in Intracerebral Hemorrhage

December 24, 2024 updated by: Yasmin Sherif Mosabah, Assiut University

Predictive Value of Blood-based Biomarkers on the Functional Outcome in Young Adult Patients with Spontaneous Intracerebral Hemorrhage

Explore blood based biomarkers in patients with intracerebral haemorrhage [cbc. Pt. LDH.CRP. Cholesterol. Na. K.. Mg. Urea Ca. Uric acid]

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Detailed Description

Spontaneous intracerebral hemorrhage (ICH) is a common subtype of stroke and accounts for nearly 10% to 30% of all strokes [1]. ICH posed a significant health burden in China in 2019, contributing to 25 million disability-adjusted life years (DALYs). It is associated with an early mortality rate of approximately 30-40% and has shown no reduction in prevalence in recent decades [2]. The higher incidence and mortality of ICH in middle-income and low-income countries may be attributed to limited public awareness regarding preventive measures, as well as challenges in accessing healthcare services [3]. So far, few treatment possibilities have yielded conclusive benefits. However, numerous predictors of poor outcomes after ICH have been suggested, including hematoma volume, hematoma expansion, perihematomal edema (PHE), and the presence and quantity of intraventricular hemorrhage growth [4,5,6,7]. Similarly, researchers continue to search for various blood-based biomarkers to guide management and predict outcomes after acute ICH [8,9,10,11,12]. A growing number of studies have shown that many novel biomarkers, such as C-reactive protein (CRP), S100A12, and interleukin-6, are associated with adverse outcomes in patients with ICH [8,9,10]. Thus, the application of blood-based biomarkers may improve risk stratification and aid clinical decisions in patients with ICH.

Therefore, in this review, we assessed the data available in the literature regarding the diagnostic and prognostic value of circulating blood biomarkers in patients with ICH. For each biomarker, we depicted the detailed characteristics in order to shed light on potential future clinical applications Intracerebral hemorrhage (ICH) is the second most common subtype of stroke and a critical disease usually leading to severe disability or death. ICH is more common in advanced age, male sex, and low- and middle-income countries. The case fatality rate of ICH is high, and only 12% to 39% of survivors can achieve long-term functional independence. Risk factors of ICH are hypertension, current smoking, excessive alcohol consumption, hypocholesterolemia, and drugs. Clinical presentation varies according to the size and location of hematoma, and intraventricular extension of hemorrhage.

Study Type

Observational

Enrollment (Estimated)

1

Contacts and Locations

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

Study Contact

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Young adults patients

Description

  • Inclusion criteria:

    1. both sex
    2. Age between 25 to 40 years old.
    3. symptoms suggestive of intracerebral hemorrhage

      Exclusion criteria:

    1. Age group below 25 years and above 40 years
    2. traumatic cerebral haemorrhage
    3. extradural,subdural,subarachnoid hemorrhage
    4. Hemorrhagic infarction

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

Cohorts and Interventions

Group / Cohort
Young adults with intracerebral haemorrhage
Cohort prospective study for detection of blood based biomarkers of intracerebral hemorrhage in young adults.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
: Predictive value of blood-based biomarkers on the functional outcome in young adult patients with spontaneous intracerebral hemorrhage.
Time Frame: 2 years
Explore blood based biomarkers in patients with intracerebral haemorrhage [cbc. Pt. LDH.CRP. Cholesterol. Na. K.. Mg. Urea Ca. Uric acid]
2 years
: Predictive value of blood-based biomarkers on the functional outcome in young adult patients with spontaneous intracerebral hemorrhage.
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
: Predictive value of blood-based biomarkers on the functional outcome in young adult patients with spontaneous intracerebral hemorrhage.
Time Frame: 2 years
2 years

Collaborators and Investigators

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

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 (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 16, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 24, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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