Bleeding After GI Endoscopy
Conditions
Keywords
lower gastrointestinal bleeding, tranexamic acid, sucralfate
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.
Detailed description
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.
Interventions
DRUGTranexamic acid and sucralfate powder spray
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.
OTHERStandard endsocopic 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.
Sponsors
National Cheng-Kung University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rebleeding within 28 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| index lesion rebleeding requiring transarterial embolization or emergent surgery | 28 days | index lesion rebleeding requiring transarterial embolization or emergent surgery |
| the duration of hospitalization | 28 days | the duration of hospitalization |
| transfusion units of packed red blood cells | 28 days | transfusion units of packed red blood cells |
| bleeding related mortality | 28 days | bleeding related mortality |
Contacts
CONTACTHsueh-Chien Chiang, MD
CONTACTXi-Zhang Lin
PRINCIPAL_INVESTIGATORHsueh-Chien Chiang
National Cheng-Kung University Hospital
Outcome results
None listed