Single Dose Enteral Tranexamic Acid in Critically Ill Patients

The primary objective of this study is to provide preliminary efficacy and safety data on
the enteral administration of a one-time dose of tranexamic acid to critically ill patients
for the reduction of morbidity at 28 days after enrollment in the study.

Secondary objectives of this study are to determine the efficacy of administration of
enteral tranexamic acid in reducing intensive care unit (ICU) and hospital length-of-stay,
as well and mortality and morbidity at 6 months.

Inclusion Criteria:

- Critically ill patients admitted to ICU within 48 hours of onset of illness

- Patients with feeding tubes (e.g., orogastric, nasogastric, PEG, etc.)

Exclusion Criteria:

- primary admitting diagnosis of cancer

- primary admitting diagnosis of acute congestive heart failure

- primary admitting diagnosis of chronic obstructive pulmonary disease (COPD)

- primary admitting diagnosis of acute myocardial infarction or unstable cardiac
arrythmia

- primary admitting diagnosis of amyotrophic lateral sclerosis (ALS) or other
non-infectious disease

- primary admitting diagnosis of post-operative neurosurgical procedure

- known hypersensitivity to tranexamic acid

- acquired disturbances of color vision

- hematuria cause by disease of the renal parenchyma

- active thromboembolic disease such as deep venous thrombosis or pulmonary embolism

- patients with known clotting disorders or other known bleeding disorders

- recent (within 3 months) or active cerebrovascular bleed

- pregnancy

- inability to take study medicine (i.e., ileus with > 500ml stomach residuals, NPO
status)

- patients excluded at the discretion of the treating physician