Acute Brain Injury, Hemorrhagic Stroke, Intracerebral, Intracerebral Hemorrhage (ICH), Neurocritical Care, Ultrasound
Conditions
Keywords
spleen volume change, ΔSpleen, ΔHematoma, 45-day mortality risk, neurocritical care
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTPOCUS-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.
Sponsors
Ankara City Hospital Bilkent
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in spleen volume (ΔSpleen) from baseline to 72 hours | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 45-day all-cause mortality | 45 days | Mortality status will be assessed through hospital records and the national electronic health system. Unit of Measure: percentage of patients (%) |
| Change in hematoma volume (ΔHematoma) from baseline to 72 hours | Hematoma volume change calculated as 72-hour minus baseline measurements | 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) |
| Baseline Glasgow Coma Scale (GCS) scores | Baseline Glasgow Coma Scale measured within 24 hours of admission | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed