Precise Application of Topical Tranexamic Acid to Enhance Endoscopic Hemostasis for Peptic Ulcer Bleeding: A Randomized Controlled Study

A-BR-110-085

Peptic ulcer bleeding is a common emergency for patients who need therapeutic endoscopy. According to international guidelines and Taiwan consensus, the standard therapy included proton pump inhibitor (PPI) and endoscopic therapy. For high-risk peptic ulcers, such as active spurting, oozing bleeding, a nonbleeding visible vessel or ulcers with adherent clots, we apply endoscopic hemostasis with epinephrine injection in combination with either heater probe coagulation, hemoclipping and/or rubber band ligation. Parenteral high-dose PPI is administered after endoscopic hemostasis. Though current standard endoscopic therapy plus PPI infusion are highly effective, 5%-10% of the patients still experience recurrence of bleeding after the initial treatment. It is still an important issue to reduce recurrent peptic ulcer bleeding after standard endoscopic therapy. Tranexamic acid reduces bleeding by inhibiting clot breakdown by inhibiting the degradation of fibrin by plasmin. It is effective to be used topically to reduce bleeding during surgery. However, the effect of application of tranexamic acid orally or intravenously for gastrointestinal bleeding was still controversial, probably because that the route of tranexamic acid use is not precise at the bleeding site. Tranexamic acid has anti-fibrinolytic effects at the bleeding site, so it is possible that use of tranexamic acid locally may have better efficacy than via intravenous or oral route. We propose to investigate the effectiveness and safety when using tranexamic acid locally under endoscopic guidance in patients with peptic ulcer bleeding after standard endoscopic therapy.

2022-03-24

2023-03-31

2023-03-31

Completed

60

Inclusion Criteria: * Patients with peptic ulcer with major stigmata of recent hemorrhage receiving EGD therapy Exclusion Criteria: * Poor renal function (serum creatinine \> 2.9mg/dL) * Tumor ulcer bleeding * Patients allergy to tranexamic acid * Whose antiplatelet agent/anticoagulation agent could not be transiently withdrawn

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

2023-05-06