Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage

• Sponsor: Kocaeli University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02903017
• Collaborator: (none)
• Enrollment: 114
• Location: 1
• Arms: 2
• Duration (Months): 17.9
• Patients Per Site Per Month: 6.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Hemorrhage; Tranexamic Acid; Emergency Department; Antifibrinolytic Agents	Drug: Tranexamic acid 5%; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage: A Double-Blind, Randomized, Placebo-Controlled Trial
• Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mortality [One month]

   In- or out of hospital mortality

2. Re-bleeding [One month]

   Recurrent upper gastrointestinal hemorrhage

3. Endoscopic intervention need [One month]

4. Surgical intervention need [One month]

5. ED revisit [One month]

Secondary Outcome Measures

1. Length of stay in the hospital [One month]

2. Administered blood products in the ED [One month]

3. Adverse reactions [One month]

   Thromboembolic events, anaphylaxis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kocaeli University, Faculty of Medicine	Kocaeli		Turkey	41050

Sponsors and Collaborators

• Kocaeli University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

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

• Responsible Party: Nurettin Özgür Doğan, M.D., Associate Professor, Kocaeli University
• ClinicalTrials.gov Identifier: NCT02903017
• Other Study ID Numbers: KIA 2016/196
• First Posted: Sep 16, 2016
• Last Update Posted: Mar 6, 2018
• Last Verified: Mar 1, 2018

• Additional relevant MeSH terms: Gastrointestinal Hemorrhage; Emergencies; Hemorrhage; Tranexamic Acid

Study Results

No Results Posted as of Mar 6, 2018