Single Dose Enteral Tranexamic Acid in Critically Ill Patients

This study has been completed.

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: November 17, 2014

Last verified: November 2014

History of Changes

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:

MedlinePlus related topics: Sepsis Shock

Drug Information available for: Tranexamic acid

U.S. FDA Resources

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


Enrollment:	4
Study Start Date:	June 2012
Study Completion Date:	November 2014
Primary Completion Date:	November 2014 (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

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

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:	November 17, 2014
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:


Tranexamic Acid Antifibrinolytic Agents Coagulants Fibrin Modulating Agents Hematologic Agents	Hemostatics Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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