Single Dose Enteral Tranexamic Acid in Critically Ill Patients
|Shock Sepsis Hypotension Critical Illness||Drug: Tranexamic Acid Drug: Control Intervention (Carrier fluid only)||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Single Dose Enteral Tranexamic Acid for the Reduction of Morbidity in Hospitalized Critically Ill Patients|
- Morbidity [ Time Frame: 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]
- morbidity [ Time Frame: 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 [ Time Frame: 28 days ]All-cause death will be measured at 28 days
- mortality [ Time Frame: 6 months ]All cause mortality will be measured at 6 months
- ICU length of stay [ Time Frame: up to 6 months ]Time spent as a patient in the ICU will be measured
- Hospital length of stay [ Time Frame: up to 6 months ]Time spent in the hospital as a patient will be measured
|Study Start Date:||June 2012|
|Study Completion Date:||November 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
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.
|Drug: Control Intervention (Carrier fluid only)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683747
|United States, California|
|VA San Diego Health Care System|
|San Diego, California, United States, 92161|
|Principal Investigator:||Erik B Kistler, MD, PhD||VA San Diego Healthcare/University of California, San Diego|