Gastrointestinal Hemorrhage Clinical Trial
Official title:
Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage: A Double-Blind, Randomized, Placebo-Controlled Trial
Verified date | March 2018 |
Source | Kocaeli University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Kocaeli University, Faculty of Medicine | Kocaeli |
Lead Sponsor | Collaborator |
---|---|
Kocaeli University |
Turkey,
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
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 |
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