Gastrointestinal HemorrhageNCT07002359
Assessment of Laboratory Parameters and Imaging Findings in Patients With Gastrointestinal Bleeding
An observational study of Gastrointestinal Hemorrhage, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Hemorrhage
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 May 2023to 15 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who presented to the emergency department with suspected gastrointestinal bleeding were included in the study.
Who may be able to join
None listed.
Who cannot join
- Pregnancy
- Trauma-related bleeding
- Chronic comorbidities
- Lack of informed consent
- Refused hospitalization
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Süleyman Demirel Üniversitesi Tıp Fakültesi
Isparta
About this study
Official title: Assessment of Laboratory Parameters Along With Jugular Vein and Carotid Artery Diameters on Ultrasound in Patients With Gastrointestinal Bleeding
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.
Read more
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.
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)
- Conditions
- Gastrointestinal Hemorrhage
- Medical subject headings
- Gastrointestinal Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Among Patients with Gastrointestinal Hemorrhage
Measured: One Mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start9 May 2023
- Primary completion1 Mar 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DENİZ ERDEM, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07002359
- Sponsor's protocol ID
- AIBU-ACİL-DE-01
- Status last verified
- Oct 2026
- First submitted
- 13 May 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Laboratory Parameters Along With Jugular Vein and Carotid Artery Diameters on Ultrasound in Patients With Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT07002359
- Acronym / sponsor ID
- AIBU-ACİL-DE-01
- Conditions
- Gastrointestinal Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 9 May 2023 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 3 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who presented to the emergency department with suspected gastrointestinal bleeding were included in the study.
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Pregnancy
- Trauma-related bleeding
- Chronic comorbidities
- Lack of informed consent
- Refused hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality Among Patients with Gastrointestinal Hemorrhage
Time frame: One Mounth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Hemorrhage, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality Among Patients with Gastrointestinal Hemorrhage (time frame: One Mounth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.