Spraying tranexamic acid and sucralfate powders to stop bleeding from upper GI tumors
Endoscopic Application of Tranexamic Acid and Sucralfate in Gastrointestinal Tumor Bleeding: A Randomized Controlled Trial
NA · National Cheng-Kung University Hospital · NCT07540026
Doctors will try spraying tranexamic acid and sucralfate powders during endoscopy to stop bleeding in adults with upper gastrointestinal tumor bleeding.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Cheng-Kung University Hospital (other) |
| Locations | 1 site (Tainan, Not Required For This Country) |
| Trial ID | NCT07540026 on ClinicalTrials.gov |
What this trial studies
This randomized interventional trial enrolls adults with upper GI tumor bleeding who require endoscopic hemostasis and randomizes them to receive endoscopic application of drug powders versus standard hemostatic care. The active treatment combines 3 g of sucralfate powder and 1.5 g of tranexamic acid powder sprayed onto the bleeding tumor surface during endoscopy. Primary outcomes include immediate hemostasis and subsequent rebleeding rates, with follow-up to capture recurrence and need for further interventions. The trial is conducted at National Cheng Kung University Hospital in Tainan, Taiwan as a single-center study.
Who should consider this trial
Good fit: Adults aged 18 or older undergoing endoscopy for upper GI tumor bleeding who need endoscopic hemostasis and have no contraindication to tranexamic acid or sucralfate are eligible.
Not a fit: Patients who do not require endoscopic hemostasis, are allergic to the study drugs, are pregnant, or have hollow organ perforation are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could improve immediate bleeding control and lower rebleeding rates, reducing transfusions and the need for additional procedures.
How similar studies have performed: Hemostatic powder spraying has improved control and reduced recurrence in trials for peptic ulcers and post-polypectomy bleeding, but applying tranexamic acid plus sucralfate powders specifically for tumor bleeding is a relatively new approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tainan, Not Required For This Country
- National Cheng Kung University Hospital — Tainan, Not Required For This Country, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Hsueh-Chien Chiang, MD
- Email: scion456scion@gmail.com
- Phone: 8862353535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bleeding After GI Endoscopy, Gastric tumor, Tumor bleeding