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Single Dose Enteral Tranexamic Acid in Critically Ill Patients

Primary Purpose

Shock, Sepsis, Hypotension

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Tranexamic Acid

Control Intervention (Carrier fluid only)

About this trial

This is an interventional treatment trial for Shock focused on measuring sepsis, shock, placebo controlled, double blinded, interventional

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA San Diego Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tranexamic acid

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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]

Secondary Outcome Measures

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]

mortality

All-cause death will be measured at 28 days

mortality

All cause mortality will be measured at 6 months

ICU length of stay

Time spent as a patient in the ICU will be measured

Hospital length of stay

Time spent in the hospital as a patient will be measured

Full Information

NCT ID

NCT01683747

First Posted

September 9, 2012

Last Updated

November 16, 2015

Sponsor

San Diego Veterans Healthcare System

Collaborators

Inflammagen/Leading Ventures

1. Study Identification

Unique Protocol Identification Number

NCT01683747

Brief Title

Single Dose Enteral Tranexamic Acid in Critically Ill Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Terminated

Why Stopped

Lower than anticipated enrollment

Study Start Date

June 2012 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

San Diego Veterans Healthcare System

Collaborators

Inflammagen/Leading Ventures

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Shock, Sepsis, Hypotension, Critical Illness

Keywords

sepsis, shock, placebo controlled, double blinded, interventional

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tranexamic acid

Arm Type

Experimental

Arm Description

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

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Tranexamic Acid

Other Intervention Name(s)

Cyclokapron

Intervention Type

Drug

Intervention Name(s)

Control Intervention (Carrier fluid only)

Primary Outcome Measure Information:

Title

Morbidity

Description

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]

Time Frame

28 days

Secondary Outcome Measure Information:

Title

morbidity

Description

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]

Time Frame

6 months

Title

mortality

Description

All-cause death will be measured at 28 days

Time Frame

28 days

Title

mortality

Description

All cause mortality will be measured at 6 months

Time Frame

6 months

Title

ICU length of stay

Description

Time spent as a patient in the ICU will be measured

Time Frame

up to 6 months

Title

Hospital length of stay

Description

Time spent in the hospital as a patient will be measured

Time Frame

up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Erik B Kistler, MD, PhD

Organizational Affiliation

VA San Diego Healthcare/University of California, San Diego

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA San Diego Health Care System

City

San Diego

State/Province

California

ZIP/Postal Code

92161

Country

United States

12. IPD Sharing Statement

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Single Dose Enteral Tranexamic Acid in Critically Ill Patients

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