Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastrointestinal Hemorrhage Tranexamic Acid Emergency Department Antifibrinolytic Agents

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Tranexamic acid 5%

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

Group Type ACTIVE_COMPARATOR

Tranexamic acid 5%

Intervention Type DRUG

Via nasogastric tube, 100 mL

Placebo

0.9% normal saline solution (total 100 mL)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Via nasogastric tube, 100 mL

Interventions

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Tranexamic acid 5%

Via nasogastric tube, 100 mL

Intervention Type DRUG

Placebo

Via nasogastric tube, 100 mL

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No