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.

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

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.

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.

The individual participant data (IPD) and supporting documentation will be available starting six months after the publication of the primary study results. Data access will remain open for a period of five years from the start date. During this time, qualified researchers can request access to the de-identified dataset and associated metadata for secondary analyses. After the five-year period, data availability will be reviewed and may be extended depending on data management policies and resource availability.

Access to the individual participant data (IPD) and supporting documentation will be granted to qualified researchers who submit a formal data request outlining the objectives and methods of their proposed analysis. Researchers must agree to use the data solely for approved research purposes and to maintain confidentiality and data security. The shared data will include fully de-identified participant information and relevant metadata necessary to understand the dataset. Access will be provided through a secure data sharing platform or via direct transfer after approval by the study's data sharing committee. Requests will be reviewed based on scientific merit and ethical considerations.