Single Dose Enteral Tranexamic Acid in Critically Ill Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Shock, Sepsis, Hypotension, Critical Illness

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Control Intervention (Carrier fluid only)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid<br>Study group receives enteral tranexamic acid in normal saline in addition to usual care. | Drug: Tranexamic Acid<br> <br> * Other names: Cyclokapron;|
| Placebo Comparator: Control group<br>Control group receives vehicle (normal saline) without study drug and usual care. | Drug: Control Intervention (Carrier fluid only)<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, shock, placebo controlled, double blinded, interventional