- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06745037
Interventional Study for Detection of Prognosis of Blood Based Biomarkers in Intracerebral Hemorrhage
Predictive Value of Blood-based Biomarkers on the Functional Outcome in Young Adult Patients with Spontaneous Intracerebral Hemorrhage
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Yasmeen Sherif Mosabah, Resident doctor
- Phone Number: 01012752107 01030837658
- Email: Yasminsherif959@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- both sex
- Age between 25 to 40 years old.
symptoms suggestive of intracerebral hemorrhage
Exclusion criteria:
- Age group below 25 years and above 40 years
- traumatic cerebral haemorrhage
- extradural,subdural,subarachnoid hemorrhage
- Hemorrhagic infarction
Study Plan
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Intracerebral hemorrhage
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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