Skip to main content
OpenTrials
Completed

NCT Number: NCT02903017

Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastrointestinal Hemorrhage Antifibrinolytic Agents Digestive System Diseases Disease Attributes Emergencies Emergency Department Gastrointestinal Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Tranexamic Acid

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kocaeli University, Faculty of Medicine

Kocaeli, 41050, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic acid 5%

Drug

Via nasogastric tube, 100 mL

Placebo

Drug

Via nasogastric tube, 100 mL

Primary outcomes

  1. Mortality

    Time frame: One month

    In- or out of hospital mortality

  2. Re-bleeding

    Time frame: One month

    Recurrent upper gastrointestinal hemorrhage

  3. Endoscopic intervention need

    Time frame: One month

  4. Surgical intervention need

    Time frame: One month

  5. ED revisit

    Time frame: One month

Secondary outcomes

  1. Length of stay in the hospital

    Time frame: One month

  2. Administered blood products in the ED

    Time frame: One month

  3. Adverse reactions

    Time frame: One month

    Thromboembolic events, anaphylaxis

Sponsors and collaborators

Lead sponsor

Kocaeli University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Sep 16, 2016
Registry last updated
Mar 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.