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The efficacy and safety of microporous polysaccharide hemostasis powder combined with standard endoscopy versus standard endoscopy alone in the treatment of high-risk peptic ulcer bleeding: A prospective, multicenter, single-blind, randomized controlled study

The efficacy and safety of microporous polysaccharide hemostasis powder combined with standard endoscopy versus standard endoscopy alone in the treatment of high-risk peptic ulcer bleeding: A prospective, multicenter, single-blind, randomized controlled study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118511
Enrollment
Unknown
Registered
2026-02-06
Start date
2026-03-01
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peptic ulcer bleeding (Forrest Ia–IIa) requiring emergency endoscopic hemostasis

Interventions

Hemostatic Powder plus Standard Endoscopic Therapy Group:Microporous polysaccharide hemostatic powder combined with standard endoscopic hemostatic therapy
Standard Endoscopic Therapy Group:Standard endoscopic hemostatic therapy

Sponsors

The First Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18–80 years. 2. Patients undergoing standard endoscopic therapy for the first time for peptic ulcer bleeding (Forrest Ia-IIa); 3. Voluntarily agree to participate and sign the written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Failure to achieve hemostasis with standard endoscopic therapy. 2. Multiple peptic ulcer bleeding; 3. Coagulation disorders (APTT > 1.5× normal or INR > 2.5) or thrombocytopenia (PLT < 100×10?/L). 4. Concomitant esophageal variceal bleeding. 5. Inability to discontinue anticoagulant or antiplatelet therapy. 6. Severe comorbidities involving the heart, lungs, liver, or kidneys. 7. Concomitant malignant tumors. 8. History of abdominal surgery. 9. Pregnant or breastfeeding women. 10. Any other condition deemed unsuitable for participation by the investigator.

Design outcomes

Primary

MeasureTime frame
Rebleeding rate within 3 days;

Secondary

MeasureTime frame
All-cause mortality within 30 days;Length of hospital stay;Incidence of adverse events;Rebleeding rate within 30 days;Transfusion rate;

Countries

China

Contacts

Public ContactXu Shu

The First Affiliated Hospital of Nanchang University

jxmushx@126.com+86 791 88692506

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026