Clinical trial NCT01683747: Single Dose Enteral Tranexamic Acid in Critically Ill Patients
Official title: Single Dose Enteral Tranexamic Acid for the Reduction of Morbidity in Hospitalized Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Shock
Sepsis
Hypotension
Critical Illness
Keywords: sepsis
shock
placebo controlled
double blinded
interventional
Lead sponsor: San Diego Veterans Healthcare System
Sponsor class: FED
Collaborators: name: Inflammagen/Leading Ventures
First posted: 2012-09-12
Enrollment: 4
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: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Morbidity
timeFrame: 28 days
Secondary outcomes:
measure: morbidity
timeFrame: 6 months
measure: mortality
timeFrame: 28 days
measure: mortality
timeFrame: 6 months
measure: ICU length of stay
timeFrame: up to 6 months
measure: Hospital length of stay
timeFrame: up to 6 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Health Care System
state: California
Study officials:
affiliation: VA San Diego Healthcare/University of California, San Diego
name: Erik B Kistler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: