Intracerebral HemorrhageNCT06745037
Interventional Study for Detection of Prognosis of Blood Based Biomarkers in Intracerebral Hemorrhage
An observational study of Intracerebral Hemorrhage, run by Assiut University.
Trial summary
Explore blood based biomarkers in patients with intracerebral haemorrhage [cbc. Pt. LDH.CRP. Cholesterol. Na. K.. Mg. Urea Ca. Uric acid] Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracerebral Hemorrhage
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Young adults patients
Who may be able to join
- both sex
- Age between 25 to 40 years old.
- symptoms suggestive of intracerebral hemorrhage
Who cannot join
- <!-- -->
- Age group below 25 years and above 40 years
- traumatic cerebral haemorrhage
- extradural,subdural,subarachnoid hemorrhage
- Hemorrhagic infarction
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Yasmeen Sherif Mosabah, Resident doctor contact
About this study
Official title: 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]
Read the 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.
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Hemorrhage, Biomarkers, Detection
- Medical subject headings
- Cerebral Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Young adults with intracerebral haemorrhage | Cohort prospective study for detection of blood based biomarkers of intracerebral hemorrhage in young adults. |
What is being measured
The primary outcome is the main question the study is designed to answer.
: 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]
Measured: 2 years
: Predictive value of blood-based biomarkers on the functional outcome in young adult patients with spontaneous intracerebral hemorrhage.
Measured: 2 years
Secondary outcomes (1)
: Predictive value of blood-based biomarkers on the functional outcome in young adult patients with spontaneous intracerebral hemorrhage.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study startDec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Sherif Mosabah, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745037
- Sponsor's protocol ID
- Intracerebral hemorrhage
- Status last verified
- Dec 2024
- First submitted
- 16 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Blood-based Biomarkers on the Functional Outcome in Young Adult Patients with Spontaneous Intracerebral Hemorrhage
- ClinicalTrials.gov ID
- NCT06745037
- Acronym / sponsor ID
- Intracerebral hemorrhage
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Hemorrhage, Biomarkers, Detection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Explore blood based biomarkers in patients with intracerebral haemorrhage [cbc. Pt. LDH.CRP. Cholesterol. Na. K.. Mg. Urea Ca. Uric acid]
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young adults with intracerebral haemorrhage | – | –Cohort prospective study for detection of blood based biomarkers of intracerebral hemorrhage in young adults. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young adults patients
Key inclusion criteria (3 listed)
Key exclusion criteria (5 listed)
- <!-- -->
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
: 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]
: Predictive value of blood-based biomarkers on the functional outcome in young adult patients with spontaneous intracerebral hemorrhage.
Time frame: 2 years
1 secondary outcome
: Predictive value of blood-based biomarkers on the functional outcome in young adult patients with spontaneous intracerebral hemorrhage.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yasmeen Sherif Mosabah, Resident doctor contact
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmeen Sherif Mosabah, Resident doctor (01030837658 ext. 01012752107, Yasminsherif959@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
: Predictive value of blood-based biomarkers on the functional outcome in young adult patients with spontaneous intracerebral hemorrhage. (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.