Endoscopic Application of Hemostatic Drug Powder in Lower Gastrointestinal Bleeding: A Pilot Study
25. juni 2026 oppdatert av: Hsueh-Chien Chiang, National Cheng-Kung University Hospital
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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Antatt)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Hsueh-Chien Chiang, MD
- Telefonnummer: +886910890307
- E-post: scion456scion@gmail.com
Studer Kontakt Backup
- Navn: Xi-Zhang Lin
- Telefonnummer: 8862353535
- E-post: linxz@mail.ncku.edu.tw
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- patients suspect lower gastrointestinal bleeding
Exclusion Criteria:
- absence of indication for endoscopic hemostasis
- known allergy to sucralfate, TXA
- presence of a hollow organ perforation
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervention Group
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.
|
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.
|
|
Aktiv komparator: Standard group
All the enrolled patients underwent standard endoscopic hemostasis by local injection of diluted epinephrine combined with heater probe coagulation, hemoclipping, and/or band ligation.
|
All the enrolled patients underwent standard endoscopic hemostasis by local injection of diluted epinephrine combined with heater probe coagulation, hemoclipping, and/or band ligation.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rebleeding within 28 days
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
index lesion rebleeding requiring transarterial embolization or emergent surgery
Tidsramme: 28 days
|
index lesion rebleeding requiring transarterial embolization or emergent surgery
|
28 days
|
|
the duration of hospitalization
Tidsramme: 28 days
|
the duration of hospitalization
|
28 days
|
|
transfusion units of packed red blood cells
Tidsramme: 28 days
|
transfusion units of packed red blood cells
|
28 days
|
|
bleeding related mortality
Tidsramme: 28 days
|
bleeding related mortality
|
28 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Hsueh-Chien Chiang, National Cheng-Kung University Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. juli 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2027
Datoer for studieregistrering
Først innsendt
25. juni 2026
Først innsendt som oppfylte QC-kriteriene
25. juni 2026
Først lagt ut (Faktiske)
1. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- A-BR-115-031
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
After study publication
IPD-delingstidsramme
After study publication
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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