Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-03-06 @ 9:16 AM
Study NCT ID:
NCT07002359
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Laboratory Parameters and Imaging Findings in Patients With Gastrointestinal Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-10', 'studyFirstSubmitDate': '2025-05-13', 'studyFirstSubmitQcDate': '2025-06-01', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality Among Patients with Gastrointestinal Hemorrhage', 'timeFrame': 'One Mounth'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastrointestinal Hemorrhage']}, 'descriptionModule': {'briefSummary': "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.\n\n1.2. 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.\n\nFlow Chart:\n\nSuspected GIB: 420\n\nExcluded (no confirmed GIB): 182\n\nEnrolled (confirmed GIB): 238\n\nIncluded (met criteria): 76\n\nExcluded: 162 (age \\<18, pregnancy, trauma, comorbidities, no consent, refused hospitalization).\n\n1.3. Sample Size Based on pilot data (effect size 0.5, power 95%, α=0.05), 70 participants were required for significance.\n\n1.4. Data Collection Demographics, labs (Hb, Hct, lactate), hemodynamics (BP, HR, MAP), and outcomes (transfusion, ICU admission, mortality) were recorded.\n\nUltrasonography: 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.\n\nScoring: Glasgow-Blatchford score (GBS) assessed bleeding severity.\n\n1.5. Ethical Approval Approved by the local ethics committee (Decision #12, Meeting 92; Feb 20, 2025).\n\n1.6. Quality Evaluation Conducted per Declaration of Helsinki and STROBE guidelines.\n\n1.7. Statistical Analysis Normality: Kolmogorov-Smirnov test.\n\nComparisons: T-test/Mann-Whitney U (2 groups), ANOVA/Kruskal-Wallis (≥3 groups), Chi-square/Fisher's exact test (categorical).\n\nCorrelation: Pearson (GBS vs. US measurements).\n\nPredictive performance: ROC curves (AUC, Youden's Index for cut-offs).\n\nSurvival analysis: Kaplan-Meier, Cox regression.\n\nSoftware: SPSS 27.0, MedCalc® 20.218.\n\nSignificance: p \\< 0.05.\n\nAbbreviations (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)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who presented to the emergency department with suspected gastrointestinal bleeding were included in the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Adult patients aged 18 years and older who presented to the emergency department.\n\nPatients presenting with suspected gastrointestinal bleeding and diagnosed with GIB based on clinical, laboratory, or imaging findings.\n\nPatients who underwent bedside ultrasonography.\n\nPatients who signed the informed consent form (if required).\n\nPatients diagnosed with either upper or lower gastrointestinal bleeding.\n\nExclusion Criteria:Age \\<18 years\n\n* Pregnancy\n* Trauma-related bleeding\n* Chronic comorbidities\n* Lack of informed consent\n* Refused hospitalization'}, 'identificationModule': {'nctId': 'NCT07002359', 'briefTitle': 'Assessment of Laboratory Parameters and Imaging Findings in Patients With Gastrointestinal Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Suleyman Demirel University'}, 'officialTitle': 'Assessment of Laboratory Parameters Along With Jugular Vein and Carotid Artery Diameters on Ultrasound in Patients With Gastrointestinal Bleeding', 'orgStudyIdInfo': {'id': 'AIBU-ACİL-DE-01'}}, 'contactsLocationsModule': {'locations': [{'city': 'Isparta', 'country': 'Turkey (Türkiye)', 'facility': 'Süleyman Demirel Üniversitesi Tıp Fakültesi', 'geoPoint': {'lat': 37.76444, 'lon': 30.55222}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suleyman Demirel University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doktor', 'investigatorFullName': 'DENİZ ERDEM', 'investigatorAffiliation': 'Suleyman Demirel University'}}}}