Correlation of Spleen Size and Hematoma Volume With Clinical Course and 45- Day Mortality in Emergency Patients With Hemorrhagic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in spleen volume (ΔSpleen) from baseline to 72 hours
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in spleen volume (ΔSpleen) from baseline to 72 hours
时间窗: 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)
次要结局
- 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)
- 45-day all-cause mortality(45 days)
研究者
Cagdas Yildirim, MD
Assistant Professor
Ankara City Hospital Bilkent