Trial | NCT01683747  Report issue

Title

Single Dose Enteral Tranexamic Acid in Critically Ill Patients
Single Dose Enteral Tranexamic Acid for the Reduction of Morbidity in Hospitalized Critically Ill Patients

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    tranexamic acid ...

  • Study Participants

    4
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.
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.
Study Started
Jun 30
2012
Primary Completion
Nov 30
2014
Study Completion
Nov 30
2014
Last Update
Nov 17
2015
Estimate

Drug Tranexamic Acid

  • Other names: Cyclokapron

Drug Control Intervention (Carrier fluid only)

Tranexamic acid Experimental

Study group receives enteral tranexamic acid in normal saline in addition to usual care.

Control group Placebo Comparator

Control group receives vehicle (normal saline) without study drug and usual care.

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
No Results Posted