Spleen Volume Change Predicts 45-Day Mortality in Neurocritical Care: A Prospective Cohort Study (SCOPE)

Ankara City Hospital

Status: Completed

Conditions: Hemorrhagic Stroke, Intracerebral; Neurocritical Care; Intracerebral Hemorrhage (ICH); Acute Brain Injury; Ultrasound

Treatments: Diagnostic Test: POCUS-based Splenic Volume Measurement

Study type: Observational

Funder types: Other

Identifiers

NCT07132996

E1:24:29

E1 24 29 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

42 participants in 2 patient groups

Decreased Spleen Volume Group (ΔSpleen < 0 mL)

Description:

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.

Treatment:

Diagnostic Test: POCUS-based Splenic Volume Measurement

Stable/ Increased Spleen Volume Group (ΔSpleen ≥ 0 mL)

Description:

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.

Treatment:

Diagnostic Test: POCUS-based Splenic Volume Measurement