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Precise Delivery of Tranexamic Acid to Enhance Endoscopic Hemostasis for Peptic Ulcer Bleeding

NCT05248321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-05-06

No results posted yet for this study

Summary

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.

Conditions

  • Peptic Ulcer Hemorrhage

Interventions

DRUG

Tranexamic Acid Powder

2g tranexamic acid powder will be given via the endoscopy directly to the peptic ulcer

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    lead OTHER

Principal Investigators

  • Xi-Zhang Lin, M.D. · National Cheng-Kung University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05248321 on ClinicalTrials.gov