Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage

Kocaeli University

Status and phase: Completed; Phase 4

Conditions: Antifibrinolytic Agents; Emergency Department; Gastrointestinal Hemorrhage; Tranexamic Acid

Treatments: Drug: Placebo; Drug: Tranexamic acid 5%

Study type: Interventional

Funder types: Other

Identifiers

NCT02903017

KIA 2016/196

Details and patient eligibility

About

Upper gastrointestinal hemorrhage is a frequently diagnosis in emergency departments. Although new drugs and endoscopic techniques were easily applied in various settings in this condition, the role of local administered therapies such as antifibrinolytic agents remain unclear. The investigators aimed to compare standard therapy (proton pump inhibitors, endoscopic treatments etc.) and standard therapy + local administered tranexamic acid in upper gastrointestinal hemorrhage in a double-blind, randomized trial.

Enrollment: 114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients presenting with upper gastrointestinal hemorrhage to the ED
• Patients older than 18 years
• Patients who agree to participate the study by reading and signing the informed consent form

Exclusion criteria

• Patients younger than 18 years
• Patients who do not agree to participate the study
• Documented or declared allergy to tranexamic acid
• Upper gastrointestinal hemorrhage secondary to trauma
• Upper gastrointestinal hemorrhage secondary to esophageal varices
• Patients who cannot undergo to endoscopy for any reason
• History for thromboembolic disease
• Patients with renal impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 2 patient groups, including a placebo group

Tranexamic acid 5%

Active Comparator group

Description:

Tranexamic acid 5%, 2000 mg (40 mL) in 60 mL normal saline (0.9%) solution (total 100 mL)

Treatment:

Drug: Tranexamic acid 5%

Placebo

Placebo Comparator group

Description:

0.9% normal saline solution (total 100 mL)

Treatment:

Drug: Placebo