Upper gastrointestinal bleeding
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Patients with suspected upper gastrointestinal bleeding Patients with a HARBINGER of 2 or 3
Exclusion criteria
Exclusion criteria: (i) Persistent fresh hematemesis or hematochezia after consultation with a gastroenterologist (ii) Patients with blood pressure less than 90 mmHg at study entry (patients with blood pressure less than 90 mmHg before entry but recovered by transfusion etc. are not excluded) (iii) Unable to obtain the patient's consent (e.g., impaired consciousness or dementia) (iv) Medically-induced bleeding (e.g., after ESD, EMR, or biopsy) (v) Pregnant women (vi) Patients with terminal cancer whose prognosis is expected to be within 3 months (regardless of carcinoma) (vii) Patients who are judged to be unsuitable by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of further bleeding (bleeding that cannot be stopped by endoscopy or rebleeding once hemostasis is confirmed) within 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Further bleeding (within 7 and 30 days of allocation) Bleeding not stopped by initial endoscopy Rate of initial endoscopic procedures Rebleeding rate (within 7 and 30 days of allocation) Transfusion rate, transfusion units (within 30 days of allocation) Hemostatic angiography rate (within 30 days of allocation) Hemostatic surgery rate (within 30 days of allocation) All-cause mortality (within 30 days of allocation) Hospitalization days Number of days spent in intensive care units (ICUs, HCUs, critical care centers, etc.) Cost Adverse events (from allocation to endoscopy and within 30 days) | — |
Countries
Japan
Contacts
Keio University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine