Single Dose Enteral Tranexamic Acid in Critically Ill Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by San Diego Veterans Healthcare System
Sponsor:
Collaborator:
Inflammagen/Leading Ventures
Information provided by (Responsible Party):
Erik B. Kistler, MD, PhD, San Diego Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01683747
First received: September 9, 2012
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Shock
Sepsis
Hypotension
Critical Illness
Drug: Tranexamic Acid
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Dose Enteral Tranexamic Acid for the Reduction of Morbidity in Hospitalized Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by San Diego Veterans Healthcare System:

Primary Outcome Measures:
  • Morbidity [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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]


Secondary Outcome Measures:
  • morbidity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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]

  • mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    All-cause death will be measured at 28 days

  • mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    All cause mortality will be measured at 6 months

  • ICU length of stay [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Time spent as a patient in the ICU will be measured

  • Hospital length of stay [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Time spent in the hospital as a patient will be measured


Estimated Enrollment: 200
Study Start Date: June 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tranexamic acid
Study group receives enteral tranexamic acid in normal saline in addition to usual care.
Drug: Tranexamic Acid
Other Name: Cyclokapron
Placebo Comparator: Control group
Control group receives vehicle (normal saline) without study drug and usual care.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683747

Contacts
Contact: Erik B Kistler, MD, PhD 858-642-3150 ekistler@ucsd.edu

Locations
United States, California
VA San Diego Health Care System Recruiting
San Diego, California, United States, 92161
Contact: Erik B Kistler, MD, PhD    858-642-3150    ekistler@ucsd.edu   
Principal Investigator: Erik B Kistler, MD, PhD         
Sponsors and Collaborators
San Diego Veterans Healthcare System
Inflammagen/Leading Ventures
Investigators
Principal Investigator: Erik B Kistler, MD, PhD VA San Diego Healthcare/University of California, San Diego
  More Information

No publications provided

Responsible Party: Erik B. Kistler, MD, PhD, Principal Investigator, Assistant Professor, San Diego Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT01683747     History of Changes
Other Study ID Numbers: 110376
Study First Received: September 9, 2012
Last Updated: September 11, 2012
Health Authority: United States: Federal Government
United States: Data and Safety Monitoring Board
United States: Institutional Review Board
United States: VA Research & Development Committee

Keywords provided by San Diego Veterans Healthcare System:
sepsis
shock
placebo controlled
double blinded
interventional

Additional relevant MeSH terms:
Hypotension
Critical Illness
Disease Attributes
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014