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

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).

Study Overview

• Status: Completed
• Conditions: Ultrasound; Acute Brain Injury; Hemorrhagic Stroke, Intracerebral; Intracerebral Hemorrhage (ICH); Neurocritical Care
• Intervention / Treatment: Diagnostic test: POCUS-based Splenic Volume Measurement

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 Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Ankara Bilkent City Hospital Emergency Medicine Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline (within 24 hours of admission) and 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%)	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)	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.	Baseline Glasgow Coma Scale measured within 24 hours of admission

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Cagdas Yildirim, Assistant Professor, Ankara City Hospital Bilkent; Study Chair: Kadir Yenal, Attending Physician, Ankara City Hospital Bilkent

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Actual): September 15, 2024
• Study Completion (Actual): October 30, 2024

Study Registration Dates

• First Submitted: August 11, 2025
• First Submitted That Met QC Criteria: August 19, 2025
• First Posted (Actual): August 20, 2025

Study Record Updates

• Last Update Posted (Actual): August 20, 2025
• Last Update Submitted That Met QC Criteria: August 19, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: neurocritical care; spleen volume change; ΔSpleen; ΔHematoma; 45-day mortality risk
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Craniocerebral Trauma; Trauma, Nervous System; Intracranial Hemorrhages; Stroke; Hemorrhagic Stroke; Brain Injuries; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: E1:24:29; E1 24 29 (Registry Identifier: The Ministry of Health Ankara Bilkent City Hospital Clinical Research Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No