Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02903017
• Date of registration: 12/09/2016
• Prospective Registration: No
• Primary sponsor: Kocaeli University
• Public title: Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage
• Scientific title: Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage: A Double-Blind, Randomized, Placebo-Controlled Trial
• Date of first enrolment: September 2016
• Target sample size: 114
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02903017
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 4

Countries of recruitment

Turkey

Contacts

• Name: Nurettin Özgür Dogan, M.D., Assoc. Prof.
• Affiliation: Kocaeli University, Faculty of Medicine

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Antifibrinolytic Agents

Gastrointestinal Hemorrhage

Emergency Department

Tranexamic Acid

Intervention(s)

Drug: Placebo

Drug: Tranexamic acid 5%

Primary Outcome(s)

ED revisit [Time Frame: One month]

Endoscopic intervention need [Time Frame: One month]

Surgical intervention need [Time Frame: One month]

Re-bleeding [Time Frame: One month]

Mortality [Time Frame: One month]

Secondary Outcome(s)

Length of stay in the hospital [Time Frame: One month]

Administered blood products in the ED [Time Frame: One month]

Adverse reactions [Time Frame: One month]

Secondary ID(s)

KIA 2016/196

Source(s) of Monetary Support

Please refer to primary and secondary sponsors