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Assessment of Laboratory Parameters and Imaging Findings in Patients With Gastrointestinal Bleeding

Assessment of Laboratory Parameters Along With Jugular Vein and Carotid Artery Diameters on Ultrasound in Patients With Gastrointestinal Bleeding

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07002359
Enrollment
76
Registered
2025-06-03
Start date
2023-05-09
Completion date
2025-07-15
Last updated
2025-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Hemorrhage

Brief summary

METHODS 1.1. Study Design This prospective, cross-sectional, observational study was conducted in the Emergency Department of Süleyman Demirel University Hospital (Isparta, Turkey). From 55,328 annual adult ED admissions, 238 eligible gastrointestinal bleeding (GIB) patients were identified, with 76 enrolled after exclusions. Written informed consent was obtained, and the study is registered at ClinicalTrials.gov. 1.2. Participants Adult patients (≥18 years) with GIB who underwent bedside ultrasonography (May 2023-June 2025) were included. Exclusions: pregnancy, trauma, advanced organ failure, malignancy, inability to consent, or refusal. Flow Chart: Suspected GIB: 420 Excluded (no confirmed GIB): 182 Enrolled (confirmed GIB): 238 Included (met criteria): 76 Excluded: 162 (age \<18, pregnancy, trauma, comorbidities, no consent, refused hospitalization). 1.3. Sample Size Based on pilot data (effect size 0.5, power 95%, α=0.05), 70 participants were required for significance. 1.4. Data Collection Demographics, labs (Hb, Hct, lactate), hemodynamics (BP, HR, MAP), and outcomes (transfusion, ICU admission, mortality) were recorded. Ultrasonography: Performed by a certified resident (3 years' experience) using a Terason Usmart 3200T (7.5 MHz probe). IJV and CCA measurements were taken at the thyroid cartilage level. Scoring: Glasgow-Blatchford score (GBS) assessed bleeding severity. 1.5. Ethical Approval Approved by the local ethics committee (Decision #12, Meeting 92; Feb 20, 2025). 1.6. Quality Evaluation Conducted per Declaration of Helsinki and STROBE guidelines. 1.7. Statistical Analysis Normality: Kolmogorov-Smirnov test. Comparisons: T-test/Mann-Whitney U (2 groups), ANOVA/Kruskal-Wallis (≥3 groups), Chi-square/Fisher's exact test (categorical). Correlation: Pearson (GBS vs. US measurements). Predictive performance: ROC curves (AUC, Youden's Index for cut-offs). Survival analysis: Kaplan-Meier, Cox regression. Software: SPSS 27.0, MedCalc® 20.218. Significance: p \< 0.05. Abbreviations (GIB: Gastrointestinal Bleeding, ED: Emergency Department, ICU: Intensive Care Unit, Hb: Hemoglobin, Hct: Hematokrit, Plt: Platelet, MAP: Mean Arterial Pressure, GBS: Glasgow-Blatchford Score, IJV: Internal Jugular Vein, CCA: Common Carotid Artery, ROC: Receiver Operating Characteristic, AUC: Area Under the Curve, ANOVA: Analysis of Variance, SPSS: Statistical Package for the Social Sciences, STROBE: Strengthening the Reporting of Observational Studies in Epidemiology)

Interventions

None listed

Sponsors

Suleyman Demirel University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adult patients aged 18 years and older who presented to the emergency department. Patients presenting with suspected gastrointestinal bleeding and diagnosed with GIB based on clinical, laboratory, or imaging findings. Patients who underwent bedside ultrasonography. Patients who signed the informed consent form (if required). Patients diagnosed with either upper or lower gastrointestinal bleeding.

Exclusion criteria

Age \<18 years * Pregnancy * Trauma-related bleeding * Chronic comorbidities * Lack of informed consent * Refused hospitalization

Design outcomes

Primary

MeasureTime frame
Mortality Among Patients with Gastrointestinal HemorrhageOne Mounth

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026