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

NCT07132996 | Completed

• 2 other identifiers: E1:24:29E1 24 29
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

spleen volume change; ΔSpleen; ΔHematoma; 45-day mortality risk; neurocritical care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 45-day all-cause mortality

  45 days

• Change in hematoma volume (ΔHematoma) from baseline to 72 hours

  Hematoma volume change calculated as 72-hour minus baseline measurements

• Baseline Glasgow Coma Scale (GCS) scores

  Baseline Glasgow Coma Scale measured within 24 hours of admission

Study Arms (2)

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

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

Interventions

POCUS-based Splenic Volume Measurement DIAGNOSTIC_TEST

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital Emergency Medicine Department

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Hemorrhagic Stroke; Brain Injuries

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stroke; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Cagdas Yildirim, Assistant Professor

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

• Kadir Yenal, Attending Physician

  Ankara City Hospital Bilkent

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 20, 2025
• Study Start: March 15, 2024
• Primary Completion: September 15, 2024
• Study Completion: October 30, 2024
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

TU (1)