Endoscopic Application of Hemostatic Drug Powder in Lower Gastrointestinal Bleeding: A Pilot Study

NCT07679139 | Not Yet Recruiting

• 1 other identifier: A-BR-115-031
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial will enroll patients at National Cheng Kung University Hospital. All patients who are hospitalized for lower gastrointestinal bleeding and undergo colonoscopy will be invited to participate. This study uses random allocation, with one Intervention group and one Standard group. Both groups will receive standard endoscopic hemostasis. Afterward, patients in the Intervention group will receive local administration of 1.5 g of tranexamic acid and 3 g of sucralfate. Following the endoscopic procedure, patients will be directly observed for 5 minutes to confirm successful hemostasis. All patients will be followed for 28 days to assess the occurrence of post-procedural rebleeding.

Conditions

Bleeding After GI Endoscopy

Keywords

lower gastrointestinal bleeding; tranexamic acid; sucralfate

Outcome Measures

Primary Outcomes (1)

• Rebleeding within 28 days

  The primary outcome was rebleeding within 28 days, defined as recurrence of bleeding from the index lesion. Clinical indicators included persistent melena, hematochezia, hemodynamic instability (systolic blood pressure \< 90 mm Hg or heart rate \> 120 bpm), and a drop in serum hemoglobin greater than 2 g/dL. Subsequent colonoscopy should be performed for confirmation and hemostasis intervention.

  28 days

Secondary Outcomes (4)

• index lesion rebleeding requiring transarterial embolization or emergent surgery

  28 days

• the duration of hospitalization

  28 days

• transfusion units of packed red blood cells

  28 days

• bleeding related mortality

  28 days

Study Arms (2)

Intervention Group

EXPERIMENTAL

All the enrolled patients underwent standard endoscopic hemostasis by local injection of diluted epinephrine combined with heater probe coagulation, hemoclipping, and/or band ligation. Patients in the intervention group will receive local administration of 1.5 g of tranexamic acid and 3 g of sucralfate.

Drug: Tranexamic acid and sucralfate powder spray

Standard group

ACTIVE COMPARATOR

All the enrolled patients underwent standard endoscopic hemostasis by local injection of diluted epinephrine combined with heater probe coagulation, hemoclipping, and/or band ligation.

Other: Standard endsocopic hemostasis

Interventions

Tranexamic acid and sucralfate powder spray DRUG

All the enrolled patients underwent standard endoscopic hemostasis by local injection of diluted epinephrine combined with heater probe coagulation, hemoclipping, and/or band ligation. Patients in the Intervention group will receive local administration of 1.5 g of tranexamic acid and 3 g of sucralfate.

Intervention Group

Standard endsocopic hemostasis OTHER

All the enrolled patients underwent standard endoscopic hemostasis by local injection of diluted epinephrine combined with heater probe coagulation, hemoclipping, and/or band ligation.

Standard group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients suspect lower gastrointestinal bleeding

You may not qualify if:

• absence of indication for endoscopic hemostasis
• known allergy to sucralfate, TXA
• presence of a hollow organ perforation

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Related Publications (5)

• Picetti R, Shakur-Still H, Medcalf RL, Standing JF, Roberts I. What concentration of tranexamic acid is needed to inhibit fibrinolysis? A systematic review of pharmacodynamics studies. Blood Coagul Fibrinolysis. 2019 Jan;30(1):1-10. doi: 10.1097/MBC.0000000000000789.

  PMID: 30585835 BACKGROUND

• Triantafyllou K, Gkolfakis P, Gralnek IM, Oakland K, Manes G, Radaelli F, Awadie H, Camus Duboc M, Christodoulou D, Fedorov E, Guy RJ, Hollenbach M, Ibrahim M, Neeman Z, Regge D, Rodriguez de Santiago E, Tham TC, Thelin-Schmidt P, van Hooft JE. Diagnosis and management of acute lower gastrointestinal bleeding: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2021 Aug;53(8):850-868. doi: 10.1055/a-1496-8969. Epub 2021 Jun 1.

  PMID: 34062566 BACKGROUND

• Kinjo K, Aoki T, Kobayashi K, Yamauchi A, Yamada A, Omori J, Ikeya T, Aoyama T, Tominaga N, Sato Y, Kishino T, Ishii N, Sawada T, Murata M, Takao A, Mizukami K, Fujimori S, Uotani T, Fujita M, Sato H, Suzuki S, Narasaka T, Hayasaka J, Funabiki T, Kinjo Y, Mizuki A, Kiyotoki S, Mikami T, Gushima R, Fujii H, Fuyuno Y, Hikichi T, Toya Y, Narimatsu K, Manabe N, Nagaike K, Kinjo T, Sumida Y, Funakoshi S, Kobayashi K, Matsuhashi T, Komaki Y, Watanabe K, Hisabe T, Yao K, Kaise M, Nagata N. Validation of British Society of Gastroenterology guidelines for acute lower GI bleeding from 8956 cases in Japan. Gastrointest Endosc. 2025 Jun;101(6):1131-1144.e10. doi: 10.1016/j.gie.2024.11.020. Epub 2024 Nov 16.

  PMID: 39557205 BACKGROUND

• Chiang HC, Chen PJ, Yang EH, Kuo TL, Hsieh MT, Kang JW, Cheng HC, Chang WL, Chen WY, Chiu HC, Lin MY, Hong TC, Chiang CM, Chen WC, Huang KK, Lu MH, Wu MH, Chen CY, Lin XZ, Chuang CH. Clinical Trial: Precise Administration of Sucralfate Powder in Prevention of Delayed Postpolypectomy Bleeding. A Randomized Controlled Trial. Clin Transl Gastroenterol. 2025 Apr 1;16(4):e00818. doi: 10.14309/ctg.0000000000000818.

  PMID: 39836033 BACKGROUND

• Chiang HC, Chen PJ, Yang EH, Hsieh MT, Shih IC, Cheng HC, Chang WL, Chen WY, Chiu HC, Kuo HY, Tsai WC, Lo YN, Yang KC, Chiang CM, Chen WC, Huang KK, Tseng HH, Chen CY, Lin XZ, Chuang CH. Precise application of topical tranexamic acid to enhance endoscopic hemostasis for peptic ulcer bleeding: a randomized controlled study (with video). Gastrointest Endosc. 2023 Nov;98(5):755-764. doi: 10.1016/j.gie.2023.06.013. Epub 2023 Jun 24.

  PMID: 37356632 BACKGROUND

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Hsueh-Chien Chiang

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsueh-Chien Chiang, MD

CONTACT

+886910890307; scion456scion@gmail.com

Xi-Zhang Lin

CONTACT

8862353535; linxz@mail.ncku.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Model Details: Both groups will receive standard endoscopic hemostasis, including local injection of diluted epinephrine combined with heater probe coagulation, hemoclipping, and/or band ligation. Afterward, patients in the Intervention group will receive local administration of 1.5 g of tranexamic acid and 3 g of sucralfate. Following the endoscopic procedure, patients will be directly observed for 5 minutes to confirm successful hemostasis. All patients will be followed for 28 days to assess the occurrence of post-procedural rebleeding.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After study publication