Clinical trial NCT02903017: Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage
Official title: Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage: A Double-Blind, Randomized, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Hemorrhage
Tranexamic Acid
Emergency Department
Antifibrinolytic Agents
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2016-09-16
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mortality
timeFrame: One month
measure: Re-bleeding
timeFrame: One month
measure: Endoscopic intervention need
timeFrame: One month
measure: Surgical intervention need
timeFrame: One month
measure: ED revisit
timeFrame: One month
Secondary outcomes:
measure: Length of stay in the hospital
timeFrame: One month
measure: Administered blood products in the ED
timeFrame: One month
measure: Adverse reactions
timeFrame: One month
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University, Faculty of Medicine
Study officials:
affiliation: Kocaeli University, Faculty of Medicine
name: Nurettin Özgür Doğan, M.D., Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1136/gut.49.3.372.
citation: 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.
citation: 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.