Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-27 @ 1:11 PM
Study NCT ID:
NCT07002359
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Laboratory Parameters and Imaging Findings in Patients With Gastrointestinal Bleeding
Sponsor:
Suleyman Demirel University
Organization:
Study Overview
Official Title:
Assessment of Laboratory Parameters Along With Jugular Vein and Carotid Artery Diameters on Ultrasound in Patients With Gastrointestinal Bleeding
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
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)
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: