About this trial
This clinical trial will enroll patients at National Cheng Kung University Hospital. All patients who are hospitalized for lower gastrointestinal bleeding and undergo colonoscopy will be invited to participate. This study uses random allocation, with one Intervention group and one Standard group. Both groups will receive standard endoscopic hemostasis. Afterward, patients in the Intervention group will receive local administration of 1.5 g of tranexamic acid and 3 g of sucralfate. Following the endoscopic procedure, patients will be directly observed for 5 minutes to confirm successful hemostasis. All patients will be followed for 28 days to assess the occurrence of post-procedural rebleeding.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
patients suspect lower gastrointestinal bleeding
Disqualifiers
absence of indication for endoscopic hemostasis
known allergy to sucralfate, TXA
presence of a hollow organ perforation
Trial design
Parallel
Treatments tested in this trial
Tranexamic acid and sucralfate powder spray
DrugAll the enrolled patients underwent standard endoscopic hemostasis by local injection of diluted epinephrine combined with heater probe coagulation, hemoclipping, and/or band ligation. Patients in the Intervention group will receive local administration of 1.5 g of tranexamic acid and 3 g of sucralfate.
Standard endsocopic hemostasis
Other interventionAll the enrolled patients underwent standard endoscopic hemostasis by local injection of diluted epinephrine combined with heater probe coagulation, hemoclipping, and/or band ligation.
Treatment groups
Trial outcomes
Primary outcomes
Rebleeding within 28 days
The primary outcome was rebleeding within 28 days, defined as recurrence of bleeding from the index lesion. Clinical indicators included persistent melena, hematochezia, hemodynamic instability (systolic blood pressure \< 90 mm Hg or heart rate \> 120 bpm), and a drop in serum hemoglobin greater than 2 g/dL. Subsequent colonoscopy should be performed for confirmation and hemostasis intervention.
Secondary outcomes
index lesion rebleeding requiring transarterial embolization or emergent surgery
index lesion rebleeding requiring transarterial embolization or emergent surgery
the duration of hospitalization
the duration of hospitalization
transfusion units of packed red blood cells
transfusion units of packed red blood cells
bleeding related mortality
bleeding related mortality
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: