Intracerebral Hemorrhage (ICH)SCOPENCT07132996
Spleen Volume Change Predicts 45-Day Mortality in Neurocritical Care: A Prospective Cohort Study
An observational study of Intracerebral Hemorrhage (ICH) and Hemorrhagic Stroke, Intracerebral, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
This study investigates whether changes in spleen size over 72 hours can help predict the risk of death within 45 days in patients who were admitted to the emergency department with a type of bleeding in the brain called intracerebral hemorrhage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracerebral Hemorrhage (ICH), Hemorrhagic Stroke, Intracerebral, Neurocritical Care
- What is being tested?
- POCUS-based Splenic Volume Measurement
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study included 42 adult patients (≥18 years) diagnosed with intraparenchymal intracerebral hemorrhage confirmed by radiological imaging. Eligible patients underwent both baseline and 72-hour follow-up brain CT scans and abdominal ultrasound. Participants were consecutively enrolled from those presenting to the Emergency Department. Patients with incomplete imaging data, loss to follow-up before 45 days post-discharge, or conditions causing splenomegaly were excluded. Informed consent was obtained from all participants.
Who may be able to join
- Adults aged 18 years and older
- Radiologically confirmed diagnosis of intraparenchymal intracerebral hemorrhage (ICH)
- Underwent baseline and 72-hour follow-up brain CT scans
- Underwent abdominal ultrasound at baseline
- Provided written informed consent prior to participation
Who cannot join
- Incomplete or missing imaging data (brain CT or abdominal ultrasound)
- Loss to follow-up or withdrawal of consent before 45 days post-discharge
- Presence of conditions known to cause splenomegaly (e.g., hematological malignancies, liver cirrhosis, infectious diseases)
- Age under 18 years
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital Emergency Medicine Department
Ankara
About this study
Official title: Correlation of Spleen Size and Hematoma Volume With Clinical Course and 45- Day Mortality in Emergency Patients With Hemorrhagic Stroke
This study investigates whether changes in spleen size over 72 hours can help predict the risk of death within 45 days in patients who were admitted to the emergency department with a type of bleeding in the brain called intracerebral hemorrhage. The spleen is a key immune organ that may shrink or enlarge in response to injury. A total of 42 adult patients with confirmed intracerebral hemorrhage were enrolled between March and September 2024 at Ankara Bilkent City Hospital in Turkey. Spleen size and brain bleeding volume were measured by imaging tests at the time of admission and repeated 72 hours later. Patients were followed for 45 days to determine survival status. The main goal of the study was to see if spleen size change (ΔSpleen) is a better predictor of death than brain bleeding volume change (ΔHematoma).
Read the detailed description
This is a prospective observational cohort study designed to evaluate the prognostic value of spleen volume changes in patients with non-traumatic intraparenchymal hemorrhage (ICH). The study was conducted at Ankara Bilkent City Hospital Emergency Department, a tertiary care center with neurocritical care expertise, between March 15, 2024, and September 15, 2024.
A total of 42 consecutive adult patients with neuroimaging-confirmed ICH were enrolled upon admission to the emergency department. All participants underwent baseline brain computed tomography (CT) and abdominal ultrasound within the first hours of presentation. Repeat imaging studies, including brain CT and abdominal ultrasound, were performed at 72 hours after enrollment.
Spleen volume (mL) and hematoma volume (mL) were measured using standardized volumetric methods. The change in each parameter (ΔSpleen and ΔHematoma) was calculated by subtracting the baseline measurement from the 72-hour measurement. Clinical and demographic characteristics, comorbidities, and imaging findings were prospectively collected for each participant.
The primary study objective is to determine whether changes in spleen volume (ΔSpleen) are independently associated with 45-day all-cause mortality in patients with ICH. A secondary objective is to compare the prognostic performance of ΔSpleen with changes in hematoma volume (ΔHematoma).
All patients were followed for 45 days from admission. Mortality status was determined through hospital medical records and verified by the national electronic health information system. Multivariable statistical modeling will be applied to adjust for baseline clinical and radiological variables.
This study aims to provide new insights into the potential role of spleen dynamics as a prognostic biomarker in acute ICH, supporting early risk stratification strategies in the neurocritical care setting.
- Conditions
- Intracerebral Hemorrhage (ICH), Hemorrhagic Stroke, Intracerebral, Neurocritical Care, Acute Brain Injury, Ultrasound
- Being tested
- POCUS-based Splenic Volume Measurement
- Keywords
- spleen volume change, ΔSpleen, ΔHematoma, 45-day mortality risk, neurocritical care
- Medical subject headings
- Cerebral Hemorrhage, Hemorrhagic Stroke, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POCUS-based Splenic Volume MeasurementDiagnostic test
Splenic volume was measured at baseline and at 72 hours using the Butterfly iQ+ handheld ultrasound (Butterfly Network, Inc.) in abdominal preset mode. Certified POCUS operators obtained spleen length, width, and depth in standard orthogonal planes. Volumes were calculated using the prolate ellipsoid formula (length × width × depth × 0.523), a validated method in ultrasound volumetric studies. ΔSpleen was defined as the 72-hour value minus the baseline value.
| Study group | Role | What they receive |
|---|---|---|
| Decreased Spleen Volume Group (ΔSpleen < 0 mL) | Patients with spontaneous intracerebral hemorrhage who demonstrated a reduction in splenic volume from baseline to 72 hours after admission (negative ΔSpleen). Outcomes include 45-day all-cause mortality, changes in Glasgow Coma Scale, and inflammatory biomarker levels. Receives: Diagnostic Test: POCUS-based Splenic Volume Measurement | |
| Stable/ Increased Spleen Volume Group (ΔSpleen ≥ 0 mL) | Patients with spontaneous intracerebral hemorrhage who showed no change or an increase in splenic volume from baseline to 72 hours after admission (ΔSpleen ≥ 0 mL). Outcomes include 45-day all-cause mortality, changes in Glasgow Coma Scale, and inflammatory biomarker levels. Receives: Diagnostic Test: POCUS-based Splenic Volume Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in spleen volume (ΔSpleen) from baseline to 72 hours
Spleen volume will be measured using abdominal ultrasound volumetry at baseline and at 72 hours. Change (ΔSpleen) will be calculated as the difference between baseline and 72-hour measurement.
Unit of Measure: milliliters (mL)
Measured: Baseline (within 24 hours of admission) and 72 hours
Secondary outcomes (3)
45-day all-cause mortality
Mortality status will be assessed through hospital records and the national electronic health system.
Unit of Measure: percentage of patients (%)
Measured: 45 days
Change in hematoma volume (ΔHematoma) from baseline to 72 hours
Hematoma volume will be measured using brain CT volumetry at baseline and at 72 hours. Change (ΔHematoma) will be calculated as the difference between baseline and 72-hour measurement.
Unit of Measure: milliliters (mL)
Measured: Hematoma volume change calculated as 72-hour minus baseline measurements
Baseline Glasgow Coma Scale (GCS) scores
The Glasgow Coma Scale (GCS) is a standardized neurological scale used to assess the level of consciousness in patients with acute brain injury. It ranges from 3 (deep coma or death) to 15 (fully awake and oriented). In this study, baseline GCS scores are recorded upon patient admission, within 24 hours of spontaneous intracerebral hemorrhage diagnosis. The score is derived from three components: eye opening, verbal response, and motor response, each rated on a numerical scale and summed to provide the total GCS score. This measure serves as an objective indicator of initial neurological status.
Measured: Baseline Glasgow Coma Scale measured within 24 hours of admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start15 Mar 2024
- Primary completion15 Sep 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral Hemorrhage (ICH)Studies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cagdas Yildirim, MD, Ankara City Hospital Bilkent
- Investigators
- Cagdas Yildirim, Assistant Professor, Principal investigator, Ankara City Hospital BilkentKadir Yenal, Attending Physician, Study chair, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132996
- Sponsor's protocol ID
- E1:24:29
- Other IDs
- E1 24 29
- Acronym
- SCOPE
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The individual participant data (IPD) to be shared include anonymized demographic information (age, sex), clinical characteristics (baseline and 72-hour brain CT findings, abdominal ultrasound results), treatment details, and 45-day follow-up outcomes (survival status). All shared data will be fully de-identified to protect patient privacy. The dataset will exclude any direct identifiers such as names, addresses, or personal identification numbers. Data sharing will support secondary analyses and meta-analyses related to intracerebral hemorrhage and spleen volume without compromising confidentiality. Access will be granted upon reasonable request and after approval by the study's data sharing committee.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Spleen Size and Hematoma Volume With Clinical Course and 45- Day Mortality in Emergency Patients With Hemorrhagic Stroke
- ClinicalTrials.gov ID
- NCT07132996
- Acronym / sponsor ID
- SCOPE / E1:24:29
- Conditions
- Intracerebral Hemorrhage (ICH), Hemorrhagic Stroke, Intracerebral, Neurocritical Care, Acute Brain Injury, Ultrasound
- Keywords
- spleen volume change, ΔSpleen, ΔHematoma, 45-day mortality risk, neurocritical care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 20 Aug 2025 (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.
This study investigates whether changes in spleen size over 72 hours can help predict the risk of death within 45 days in patients who were admitted to the emergency department with a type of bleeding in the brain called intracerebral hemorrhage. The spleen is a key immune organ that may shrink or enlarge in response to injury. A total of 42 adult patients with confirmed intracerebral hemorrhage were enrolled between March and September 2024 at Ankara Bilkent City Hospital in Turkey. Spleen size and brain bleeding volume were measured by imaging tests at the time of admission and repeated 72 hours later. Patients were followed for 45 days to determine survival status. The main goal of the study was to see if spleen size change (ΔSpleen) is a better predictor of death than brain bleeding volume change (ΔHematoma).
Detailed description
This is a prospective observational cohort study designed to evaluate the prognostic value of spleen volume changes in patients with non-traumatic intraparenchymal hemorrhage (ICH). The study was conducted at Ankara Bilkent City Hospital Emergency Department, a tertiary care center with neurocritical care expertise, between March 15, 2024, and September 15, 2024.
A total of 42 consecutive adult patients with neuroimaging-confirmed ICH were enrolled upon admission to the emergency department. All participants underwent baseline brain computed tomography (CT) and abdominal ultrasound within the first hours of presentation. Repeat imaging studies, including brain CT and abdominal ultrasound, were performed at 72 hours after enrollment.
Spleen volume (mL) and hematoma volume (mL) were measured using standardized volumetric methods. The change in each parameter (ΔSpleen and ΔHematoma) was calculated by subtracting the baseline measurement from the 72-hour measurement. Clinical and demographic characteristics, comorbidities, and imaging findings were prospectively collected for each participant.
The primary study objective is to determine whether changes in spleen volume (ΔSpleen) are independently associated with 45-day all-cause mortality in patients with ICH. A secondary objective is to compare the prognostic performance of ΔSpleen with changes in hematoma volume (ΔHematoma).
All patients were followed for 45 days from admission. Mortality status was determined through hospital medical records and verified by the national electronic health information system. Multivariable statistical modeling will be applied to adjust for baseline clinical and radiological variables.
This study aims to provide new insights into the potential role of spleen dynamics as a prognostic biomarker in acute ICH, supporting early risk stratification strategies in the neurocritical care setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decreased Spleen Volume Group (ΔSpleen < 0 mL) | – | Diagnostic Test: POCUS-based Splenic Volume MeasurementPatients with spontaneous intracerebral hemorrhage who demonstrated a reduction in splenic volume from baseline to 72 hours after admission (negative ΔSpleen). Outcomes include 45-day all-cause mortality, changes in Glasgow Coma Scale, and inflammatory biomarker levels. |
| Stable/ Increased Spleen Volume Group (ΔSpleen ≥ 0 mL) | – | Diagnostic Test: POCUS-based Splenic Volume MeasurementPatients with spontaneous intracerebral hemorrhage who showed no change or an increase in splenic volume from baseline to 72 hours after admission (ΔSpleen ≥ 0 mL). Outcomes include 45-day all-cause mortality, changes in Glasgow Coma Scale, and inflammatory biomarker levels. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included 42 adult patients (≥18 years) diagnosed with intraparenchymal intracerebral hemorrhage confirmed by radiological imaging. Eligible patients underwent both baseline and 72-hour follow-up brain CT scans and abdominal ultrasound. Participants were consecutively enrolled from those presenting to the Emergency Department. Patients with incomplete imaging data, loss to follow-up before 45 days post-discharge, or conditions causing splenomegaly were excluded. Informed consent was obtained from all participants.
Key inclusion criteria (5 listed)
- Adults aged 18 years and older
- Radiologically confirmed diagnosis of intraparenchymal intracerebral hemorrhage (ICH)
- Underwent baseline and 72-hour follow-up brain CT scans
- Underwent abdominal ultrasound at baseline
- Provided written informed consent prior to participation
Key exclusion criteria (5 listed)
- Incomplete or missing imaging data (brain CT or abdominal ultrasound)
- Loss to follow-up or withdrawal of consent before 45 days post-discharge
- Presence of conditions known to cause splenomegaly (e.g., hematological malignancies, liver cirrhosis, infectious diseases)
- Age under 18 years
- Pregnant or breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POCUS-based Splenic Volume MeasurementSplenic volume was measured at baseline and at 72 hours using the Butterfly iQ+ handheld ultrasound (Butterfly Network, Inc.) in abdominal preset mode. Certified POCUS operators obtained spleen length, width, and depth in standard orthogonal planes. Volumes were calculated using the prolate ellipsoid formula (length × width × depth × 0.523), a validated method in ultrasound volumetric studies. ΔSpleen was defined as the 72-hour value minus the baseline value. | Diagnostic test | Decreased Spleen Volume Group (ΔSpleen < 0 mL), Stable/ Increased Spleen Volume Group (ΔSpleen ≥ 0 mL) |
Primary outcome
Change in spleen volume (ΔSpleen) from baseline to 72 hours
Time frame: Baseline (within 24 hours of admission) and 72 hours
Spleen volume will be measured using abdominal ultrasound volumetry at baseline and at 72 hours. Change (ΔSpleen) will be calculated as the difference between baseline and 72-hour measurement. Unit of Measure: milliliters (mL)
3 secondary outcomes
45-day all-cause mortality
Time frame: 45 days
Change in hematoma volume (ΔHematoma) from baseline to 72 hours
Time frame: Hematoma volume change calculated as 72-hour minus baseline measurements
Baseline Glasgow Coma Scale (GCS) scores
Time frame: Baseline Glasgow Coma Scale measured within 24 hours of admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: Yes. The individual participant data (IPD) to be shared include anonymized demographic information (age, sex), clinical characteristics (baseline and 72-hour brain CT findings, abdominal ultrasound results), treatment details, and 45-day follow-up outcomes (survival status). All shared data will be fully de-identified to protect patient privacy. The dataset will exclude any direct identifiers such as names, addresses, or personal identification numbers. Data sharing will support secondary analyses and meta-analyses related to intracerebral hemorrhage and spleen volume without compromising confidentiality. Access will be granted upon reasonable request and after approval by the study's data sharing committee.
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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. This study is not recruiting at the moment.
Cagdas Yildirim, Assistant Professor principal investigator
Ankara City Hospital Bilkent
Kadir Yenal, Attending Physician study chair
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracerebral Hemorrhage (ICH) and Hemorrhagic Stroke, Intracerebral, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 5 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: finished, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in spleen volume (ΔSpleen) from baseline to 72 hours (time frame: Baseline (within 24 hours of admission) and 72 hours). 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 20 Aug 2025.