Single Dose Enteral Tranexamic Acid in Critically Ill Patients

Stopped early · Phase 2

Conditions studied: Shock, Sepsis, Hypotension, Critical Illness

In brief

The premise of this study is that enteral tranexamic acid will help to maintain small bowel integrity, which is often compromised by critical illness due to inadequate cardiovascular perfusion (i.e., shock), and that maintenance of small bowel integrity will decrease morbidity in critically ill patients.

Key facts

Study ID: NCT01683747
Run by: San Diego Veterans Healthcare System
People needed: 4
Starts: 2012-06-01
Expected to finish: 2014-11-01
Last updated by the study team: 2015-11-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Critically ill patients admitted to ICU within 48 hours of onset of illness
Patients with feeding tubes (e.g., orogastric, nasogastric, PEG, etc.)

You may not qualify if…

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

Where it is running

VA San Diego Health Care System — San Diego, California, United States

Full record on ClinicalTrials.gov

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