Endoscopic Application of Hemostatic Drug Powder in Lower Gastrointestinal Bleeding: A Pilot Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cheng-Kung University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients suspect lower gastrointestinal bleeding

Disqualifiers

absence of indication for endoscopic hemostasis

known allergy to sucralfate, TXA

presence of a hollow organ perforation

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Standard endsocopic hemostasis

    Other intervention

    All the enrolled patients underwent standard endoscopic hemostasis by local injection of diluted epinephrine combined with heater probe coagulation, hemoclipping, and/or band ligation.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intervention GroupExperimental treatment 1 intervention
Group B: Standard groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
28 days

Secondary outcomes

1

index lesion rebleeding requiring transarterial embolization or emergent surgery

index lesion rebleeding requiring transarterial embolization or emergent surgery

Time frame
28 days
2

the duration of hospitalization

the duration of hospitalization

Time frame
28 days
3

transfusion units of packed red blood cells

transfusion units of packed red blood cells

Time frame
28 days
4

bleeding related mortality

bleeding related mortality

Time frame
28 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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