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Transfusion-related Acute Lung Injury in Patients With Liver Disease (I-TRIGER)
Transfusion-related acute lung injury (TRALI) is the most common cause of transfusion-related morbidity and mortality in the United States. It is very common and often unrecognized in the critically ill with the greatest incidence occurring in bleeding patients with liver disease. Plasma is the most blood component associated with this deadly complication and therefore patients with liver disease who frequently receive transfused plasma are at increased risk. The optimal plasma transfusion strategy for bleeding patients with liver disease is unknown and the investigators will evaluate this clinical question in a small pilot randomized controlled trial. The invstigators hypothesize that targetting a more restrictive INR Target (2.5) vs. an INR Target (1.8) will result in less hypoxemia, a TRALI surrogate without increasing bleeding complications.
Details
| Lead sponsor | University of Colorado, Denver |
|---|---|
| Phase | Phase 3 |
| Status | TERMINATED |
| Enrolment | 50 |
| Start date | 2011-07 |
| Completion | 2015-08 |
Conditions
- Respiratory Distress Syndrome, Adult
- Gastrointestinal Hemorrhage
- Liver Diseases
- Transfusion Related Lung Injury
Interventions
- Transfuse plasma to High INR target
- Transfuse plasma to Low INR target
Primary outcomes
- Mean change in PaO2/fraction of inspired oxygen (FiO2) ratio — Enrollment to 6 hours after the cessation of the transfusion protocol (54 hours)
The development of hypoxemia will not distinguish between hydrostatic edema and TRALI, but investigators believe a significant change in oxygenation is clinically relevant and a more sensitive outcome variable for all transfusion-related pulmonary complications and therefore appropriate for use in this clinical trial.
Countries
United States