NCT07540026 Endoscopic Application of Tranexamic Acid and Sucralfate in Gastrointestinal Tumor Bleeding: A Randomized Controlled Trial
| NCT ID | NCT07540026 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cheng-Kung University Hospital |
| Condition | Bleeding After GI Endoscopy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-05-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background Gastrointestinal bleeding is a common disease among the population in Taiwan, with gastrointestinal tumor bleeding accounting for 3-5% of cases. The pathophysiology of gastrointestinal tumor bleeding is unique, involving fragile surface mucosa, abnormal vascular proliferation, and malformation, making endoscopic hemostasis challenging. Conventional endoscopic hemostasis methods such as hemostatic injections, clips, or thermal coagulation have suboptimal success rates below 80%, with recurrence rates exceeding 50%. Recent clinical trials have demonstrated that hemostatic powder spraying effectively enhances hemostasis for gastrointestinal ulcers and reduces recurrence rates. Our previous research repurposed tranexamic acid in a powder form to enhance hemostasis for peptic ulcer and applied sucralfate powder to prevent postpolypectomy wound bleeding. Study aim Our research team combines previous experience by using tranexamic acid and sucralfate drug powders to spray onto bleeding gastrointestinal tumors to achieve hemostatic effects. Additionally, tumor-derived exosomes are associated with tumor angiogenesis and growth, so we hypothesize that gastrointestinal tumor bleeding may be linked to VEGF and miR-21 expression within gastrointestinal tumor exosomes. Study method This study is a clinical randomized controlled trial conducted at National Cheng Kung University Hospital. We will recruit 60 patients with gastrointestinal tumor bleeding undergoing endoscopic hemostasis. Patients in the experimental treatment group will receive additional topical administration of 1.5 g of tranexamic acid and 3 g of sucralfate drug powder. Immediate hemostasis and 30-day bleeding recurrence will be observed. Enrolled patients will also provide blood and tumor specimens for exosome analysis, evaluating the predictive effect of extracted tumor exosomes' VEGF and miR-21 on bleeding risk. This study will explore the association between specific tumor exosome expression levels and bleeding, serving as a basis for bleeding risk assessment and innovative therapies.
Eligibility Criteria
Inclusion Criteria: * patients aged ≥ 18 years who accept endoscopy for upper GI tumor bleeding Exclusion Criteria: * patients with no need for endoscopic hemostasis, allergy to sucralfate, tranexamic acid, pregnancy, and patients with hollow organ perforation
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07540026 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bleeding After GI Endoscopy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07540026 currently recruiting?
Yes, NCT07540026 is actively recruiting participants. Contact the research team at scion456scion@gmail.com for enrollment information.
Where is the NCT07540026 trial being conducted?
This trial is being conducted at Tainan, Taiwan.
Who is sponsoring the NCT07540026 clinical trial?
NCT07540026 is sponsored by National Cheng-Kung University Hospital. The trial plans to enroll 60 participants.