Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage

Gastrointestinal Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903017
• Other study ID #: KIA 2016/196
• Status: Completed
• Phase: Phase 4
• First received: September 12, 2016
• Last updated: March 5, 2018
• Start date: September 2016
• Est. completion date: March 2018

Study information

• Verified date: March 2018
• Source: Kocaeli University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Antifibrinolytic Agents
• Emergencies
• Emergency Department
• Gastrointestinal Hemorrhage
• Hemorrhage
• Tranexamic Acid

Intervention

Drug:
• Tranexamic acid 5%
Via nasogastric tube, 100 mL
• Placebo
Via nasogastric tube, 100 mL

Locations

Country	Name	City	State
Turkey	Kocaeli University, Faculty of Medicine	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

Cormack F, Chakrabarti RR, Jouhar AJ, Fearnley GR. Tranexamic acid in upper gastrointestinal haemorrhage. Lancet. 1973 Jun 2;1(7814):1207-8. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	In- or out of hospital mortality	One month
Primary	Re-bleeding	Recurrent upper gastrointestinal hemorrhage	One month
Primary	Endoscopic intervention need		One month
Primary	Surgical intervention need		One month
Primary	ED revisit		One month
Secondary	Length of stay in the hospital		One month
Secondary	Administered blood products in the ED		One month
Secondary	Adverse reactions	Thromboembolic events, anaphylaxis	One month