Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage

Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage: A Double-Blind, Randomized, Placebo-Controlled Trial

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02903017

Enrollment

114

Registered

2016-09-16

Start date

2016-09-30

Completion date

2018-03-31

Last updated

2018-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antifibrinolytic Agents, Emergency Department, Gastrointestinal Hemorrhage, Tranexamic Acid

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.

Interventions

DRUGTranexamic acid 5%

Via nasogastric tube, 100 mL

DRUGPlacebo

Via nasogastric tube, 100 mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
ED revisit	One month	—
Re-bleeding	One month	Recurrent upper gastrointestinal hemorrhage
Endoscopic intervention need	One month	—
Surgical intervention need	One month	—
Mortality	One month	In- or out of hospital mortality

Secondary

Measure	Time frame	Description
Administered blood products in the ED	One month	—
Adverse reactions	One month	Thromboembolic events, anaphylaxis
Length of stay in the hospital	One month	—

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026