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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.
This single-center randomized controlled study was conducted at our hospital and was approved by the hospital's Institutional Review Board (A-BR-115-031). Patients with confirmed LGIB were recruited.
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. All the enrolled patients underwent standard endoscopic hemostasis by 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| index lesion rebleeding requiring transarterial embolization or emergent surgery | index lesion rebleeding requiring transarterial embolization or emergent surgery | 28 days |
| the duration of hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hsueh-Chien Chiang, MD | Contact | +886910890307 | scion456scion@gmail.com | |
| Xi-Zhang Lin | Contact | 8862353535 | linxz@mail.ncku.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Hsueh-Chien Chiang | National Cheng-Kung University Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30585835 | Background | 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. | |
| 34062566 | 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. |
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After study publication
After study publication
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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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.
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|
| 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. |
|
the duration of hospitalization
| 28 days |
| transfusion units of packed red blood cells | transfusion units of packed red blood cells | 28 days |
| bleeding related mortality | bleeding related mortality | 28 days |
| 39557205 | 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. |
| 39836033 | 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. |
| 37356632 | 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. |