Precise Endoscopic Application of Tranexamic Acid and Sucralfate in Gastrointestinal Bleeding: A Randomized Controlled Trial

NCT06421389 | Completed

• 1 other identifier: B-BR-113-014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background and Aim: Gastrointestinal bleeding (GIB) is a common problem in the hospital. GIB can be divided into upper GIB, small bowel bleeding, and lower GIB. Endoscopic hemostasis includes epinephrine injection, hemoclipping, heat probe coagulation, and Argon plasma coagulation. Although the successful hemostasis rate is high, recurrent bleeding can occur, ranging from 10% to 50% according to the bleeding etiology. Therefore, how to reduce the rebleeding of GIB is an important clinical issue. Methods: This is a randomized clinical trial. Patients with gastrointestinal bleeding for endoscopy screening and treatment at National Cheng Kung University Hospital were enrolled. The study will recruit 60 patients. After randomization, 30 patients will be classified into the intervention group and 30 into the control group. The participants will receive standard endoscopic hemostasis by either local injection of diluted epinephrine, heater probe coagulation, hemoclipping, or band ligation. After then, we will spray 2g of sucralfate powder and 1g of tranexamic acid through duodenoscopy precisely on the bleeding site in the intervention group. All enrolled patients will be monitored for rebleeding for 28 days after the first endoscopy.

Conditions

Bleed Ulcer

Keywords

Bleeding ulcer; Sulcralfate; Tranexamic acid

Outcome Measures

Primary Outcomes (1)

• the recurrent rate of GI bleeding during the study period

  Recurrent bleeding was defined as remarkable hematochezia or Tarry stool with endoscopic evidence of the same site bleeding.

  28 days

Secondary Outcomes (4)

• the rate of rebleeding requiring transarterial embolization or emergency surgery

  28 days

• length of hospitalization

  28 days

• all-cause mortality rate

  28 days

• adverse events rate from powder spray

  28 days

Study Arms (2)

Intervention group

EXPERIMENTAL

All patients will receive the standard endoscopic hemostasis by either epinephrine injection, hemoclipping, heat coagulation, or band ligation. After then, patients in intervention group will receive 2g of sucralfate powder, 1g of tranexamic acid powder, and 1g of barium spray through the endoscopy precisely on the bleeding site.

Drug: Tranexamic Acid Powder

Control group

NO INTERVENTION

All patients will receive the standard endoscopic hemostasis by either epinephrine injection, hemoclipping, heat coagulation, or band ligation.

Interventions

Tranexamic Acid Powder DRUG

2g of sucralfate powder, 1g of tranexamic acid powder, and 1g of barium will be sprayed through the endoscopy precisely on the bleeding site

Also known as: sucralfate powder, barrium sulfate powder

Intervention group

Eligibility Criteria

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

You may qualify if:

• Eligible participants include patients aged ≥ 18 years who accept endoscopy for GIB, including hematemesis, Tarry stool, or bloody stool

You may not qualify if:

• no need of endoscopic hemostasis
• allergy to sucralfate, tranexamic acid, or barium
• pregnancy
• patients with hollow organ perforation

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Related Publications (4)

• Saydam SS, Molnar M, Vora P. The global epidemiology of upper and lower gastrointestinal bleeding in general population: A systematic review. World J Gastrointest Surg. 2023 Apr 27;15(4):723-739. doi: 10.4240/wjgs.v15.i4.723.

  PMID: 37206079 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

• Masuelli L, Tumino G, Turriziani M, Modesti A, Bei R. Topical use of sucralfate in epithelial wound healing: clinical evidences and molecular mechanisms of action. Recent Pat Inflamm Allergy Drug Discov. 2010 Jan;4(1):25-36. doi: 10.2174/187221310789895649.

  PMID: 19832693 BACKGROUND

• Nagata N, Niikura R, Shimbo T, Ishizuka N, Yamano K, Mizuguchi K, Akiyama J, Yanase M, Mizokami M, Uemura N. High-dose barium impaction therapy for the recurrence of colonic diverticular bleeding: a randomized controlled trial. Ann Surg. 2015 Feb;261(2):269-75. doi: 10.1097/SLA.0000000000000658.

  PMID: 25569028 BACKGROUND

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

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: May 20, 2024
• Study Start: August 15, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 18, 2025

Record last verified: 2024-07

Locations

TW (1)