A Phase 2 interventional study of Tranexamic Acid and Control Intervention (Carrier fluid only) in Shock, Sepsis and Hypotension, sponsored by San Diego Veterans Healthcare System. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-17.
Sponsored by San Diego Veterans Healthcare System · Phase 2, Interventional, and Treatment
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.
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's enrollment of 4 is below the median of 80 across 675 interventional studies indexed under Hypotension.
Browse Hypotension studies →San Diego Veterans Healthcare System is the lead sponsor of 10 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Study group receives enteral tranexamic acid in normal saline in addition to usual care.
Drug: Tranexamic Acid
Control group receives vehicle (normal saline) without study drug and usual care.
Drug: Control Intervention (Carrier fluid only)
Also known as: Cyclokapron
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 \[secondary scale\]
Time frame: 28 days
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 \[secondary scale\]
Time frame: 6 months
mortality
All-cause death will be measured at 28 days
Time frame: 28 days
mortality
All cause mortality will be measured at 6 months
Time frame: 6 months
ICU length of stay
Time spent as a patient in the ICU will be measured
Time frame: up to 6 months
Hospital length of stay
Time spent in the hospital as a patient will be measured
Time frame: up to 6 months
This study is terminated, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.
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San Diego Veterans Healthcare System