INR-Triggered Transfusion In GI Bleeders From ER (NCT01461889) | Clinical Trial Compass
TerminatedPhase 3
INR-Triggered Transfusion In GI Bleeders From ER
United States50 participantsStarted 2011-07
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Admit to an ICU due to gastrointestinal bleeding AND an INR in first 12 hours \>1.8; (INR ≥ 1.6 if received ≥ 2 units plasma)
✓. Patient has chronic liver disease defined as 1 or more of the three following diagnostic criteria:
Exclusion criteria
✕. Patient under age 18 OR pregnant OR incarcerated