Critical Illness, Hypotension, Sepsis, Shock
Conditions
Keywords
sepsis, shock, placebo controlled, double blinded, interventional
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.
Interventions
DRUGTranexamic Acid
DRUGControl Intervention (Carrier fluid only)
Sponsors
Inflammagen/Leading Ventures
San Diego Veterans Healthcare System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | 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
| Measure | Time frame | Description |
|---|---|---|
| morbidity | 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 \[secondary scale\] |
| mortality | 28 days | All-cause death will be measured at 28 days |
| ICU length of stay | up to 6 months | Time spent as a patient in the ICU will be measured |
| Hospital length of stay | up to 6 months | Time spent in the hospital as a patient will be measured |
Countries
United States
Outcome results
None listed