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Single Dose Enteral Tranexamic Acid in Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT01683747
Recruitment Status : Terminated (Lower than anticipated enrollment)
First Posted : September 12, 2012
Last Update Posted : November 17, 2015
Sponsor:
Collaborator:
Inflammagen/Leading Ventures
Information provided by (Responsible Party):
Erik B. Kistler, MD, PhD, San Diego Veterans Healthcare System

Study Description
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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.

Condition or disease Intervention/treatment Phase
Shock Sepsis Hypotension Critical Illness Drug: Tranexamic Acid Drug: Control Intervention (Carrier fluid only) Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single Dose Enteral Tranexamic Acid for the Reduction of Morbidity in Hospitalized Critically Ill Patients
Study Start Date : June 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Control Intervention (Carrier fluid only)


Outcome Measures
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Primary Outcome Measures :
  1. Morbidity [ Time Frame: 28 days ]
    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 :
  1. morbidity [ Time Frame: 6 months ]
    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]

  2. mortality [ Time Frame: 28 days ]
    All-cause death will be measured at 28 days

  3. mortality [ Time Frame: 6 months ]
    All cause mortality will be measured at 6 months

  4. ICU length of stay [ Time Frame: up to 6 months ]
    Time spent as a patient in the ICU will be measured

  5. Hospital length of stay [ Time Frame: up to 6 months ]
    Time spent in the hospital as a patient will be measured


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683747


Locations
United States, California
VA San Diego Health Care System
San Diego, California, United States, 92161
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: September 12, 2012    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015

Keywords provided by Erik B. Kistler, MD, PhD, San Diego Veterans Healthcare System:
sepsis
shock
placebo controlled
double blinded
interventional

Additional relevant MeSH terms:
Sepsis
Critical Illness
Hypotension
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Disease Attributes
 Vascular Diseases
Cardiovascular Diseases
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants