Single Dose Enteral Tranexamic Acid in Critically Ill Patients

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

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.

Study Overview

• Status: Terminated
• Conditions: Sepsis; Shock; Critical Illness; Hypotension
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Control Intervention (Carrier fluid only)

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • VA San Diego Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tranexamic acid; Study group receives enteral tranexamic acid in normal saline in addition to usual care.	Drug: Tranexamic Acid; Other Names: Cyclokapron
PLACEBO_COMPARATOR: Control group; Control group receives vehicle (normal saline) without study drug and usual care.	Drug: Control Intervention (Carrier fluid only)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbidity	Morbidity will be assessed at 28 days as measured by the validated Self-Administered Quality of Well-being Scale (QWB-SA) and 5-Point modified Oxford Handicap Scale [secondary scale]	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morbidity	Morbidity will be assessed at 28 days as measured by the validated Self-Administered Quality of Well-being Scale (QWB-SA) and 5-Point modified Oxford Handicap Scale [secondary scale]	6 months
mortality	All-cause death will be measured at 28 days	28 days
mortality	All cause mortality will be measured at 6 months	6 months
ICU length of stay	Time spent as a patient in the ICU will be measured	up to 6 months
Hospital length of stay	Time spent in the hospital as a patient will be measured	up to 6 months

Collaborators and Investigators

• Sponsor: San Diego Veterans Healthcare System
• Collaborators: Inflammagen/Leading Ventures
• Investigators: Principal Investigator: Erik B Kistler, MD, PhD, VA San Diego Healthcare/University of California, San Diego

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (ACTUAL): November 1, 2014
• Study Completion (ACTUAL): November 1, 2014

Study Registration Dates

• First Submitted: September 9, 2012
• First Submitted That Met QC Criteria: September 9, 2012
• First Posted (ESTIMATE): September 12, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): November 17, 2015
• Last Update Submitted That Met QC Criteria: November 16, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: interventional; shock; sepsis; placebo controlled; double blinded
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Critical Illness; Hypotension; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 110376