Active — Not RecruitingNot Applicable

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

Turkey (Türkiye)76 participantsStarted 2023-05-09

Plain-language 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)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mortality Among Patients with Gastrointestinal Hemorrhage

Timeframe: One Mounth

Trial details

NCT IDNCT07002359

SponsorSuleyman Demirel University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-01

View on ClinicalTrials.gov More Gastrointestinal Hemorrhage trials