An observational study in Intracerebral Hemorrhage (ICH), Hemorrhagic Stroke, Intracerebral and Neurocritical Care, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-20.
Sponsored by Ankara City Hospital Bilkent · Observational
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).
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.
476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.
This study's enrollment of 42 is below the median of 275 across 180 observational studies indexed under Cerebral Hemorrhage.
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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.
Exclusion Criteria:
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.
Diagnostic Test: POCUS-based Splenic Volume Measurement
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.
Diagnostic Test: POCUS-based Splenic Volume Measurement
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.
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)
Time frame: Baseline (within 24 hours of admission) and 72 hours
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 (%)
Time frame: 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)
Time frame: 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.
Time frame: Baseline Glasgow Coma Scale measured within 24 hours of admission
Plan to share: 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.
Supporting information: Study protocol, Sap
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Ankara City Hospital Bilkent