Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage

Phase 4

Completed

• Conditions: Gastrointestinal Hemorrhage; Tranexamic Acid; Emergency Department; Antifibrinolytic Agents
• Interventions: Drug: Tranexamic acid 5%; Drug: Placebo

• Registration Number: NCT02903017
• Lead Sponsor: Kocaeli University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-09-12
• Study First Submitted QC: 2016-09-15
• Study First Posted: 2016-09-16
• Status Verified: 2018-03
• Primary Completion: 2018-03
• Study Completion: 2018-03
• Last Update Submitted: 2018-03-05
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Re-bleeding	One month	Recurrent upper gastrointestinal hemorrhage
Mortality	One month	In- or out of hospital mortality
Endoscopic intervention need	One month
Surgical intervention need	One month
ED revisit	One month

Secondary Outcome Measures

Name	Time	Method
Adverse reactions	One month	Thromboembolic events, anaphylaxis
Length of stay in the hospital	One month
Administered blood products in the ED	One month

Trial Locations

Locations (1)

Kocaeli University, Faculty of Medicine; 🇹🇷 Kocaeli, Turkey