NCT Number: NCT07679139
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: 28 days
index lesion rebleeding requiring transarterial embolization or emergent surgery
Time frame: 28 days
the duration of hospitalization
Time frame: 28 days
transfusion units of packed red blood cells
Time frame: 28 days
bleeding related mortality
Contact information is provided by the study sponsor or research team.
Hsueh-Chien Chiang, MD
CONTACT
Xi-Zhang Lin
CONTACT
National Cheng-Kung University Hospital
Other
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