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

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Hemorrhage; Emergency Department; Tranexamic Acid; Antifibrinolytic Agents
• Intervention / Treatment: Drug: Tranexamic acid 5%; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Kocaeli, Turkey, 41050
    • Kocaeli University, Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tranexamic acid 5%; Tranexamic acid 5%, 2000 mg (40 mL) in 60 mL normal saline (0.9%) solution (total 100 mL)	Drug: Tranexamic acid 5%; Via nasogastric tube, 100 mL
Placebo Comparator: Placebo; 0.9% normal saline solution (total 100 mL)	Drug: Placebo; Via nasogastric tube, 100 mL

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Principal Investigator: Nurettin Özgür Doğan, M.D., Assoc. Prof., Kocaeli University, Faculty of Medicine

Publications and helpful links

General Publications

• Hawkey GM, Cole AT, McIntyre AS, Long RG, Hawkey CJ. Drug treatments in upper gastrointestinal bleeding: value of endoscopic findings as surrogate end points. Gut. 2001 Sep;49(3):372-9. doi: 10.1136/gut.49.3.372.
• Bergqvist D, Dahlgren S, Hessman Y. Local inhibition of the fibrinolytic system in patients with massive upper gastrointestinal hemorrhage. Ups J Med Sci. 1980;85(2):173-8. doi: 10.3109/03009738009179185.
• Cormack F, Chakrabarti RR, Jouhar AJ, Fearnley GR. Tranexamic acid in upper gastrointestinal haemorrhage. Lancet. 1973 Jun 2;1(7814):1207-8. doi: 10.1016/s0140-6736(73)90525-4. No abstract available.

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: September 15, 2016
• First Posted (Estimate): September 16, 2016

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Emergencies; Hemorrhage; Gastrointestinal Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: KIA 2016/196