NCT01461889|TerminatedPhase 3DMC
INR-Triggered Transfusion In GI Bleeders From ER
I-TRIGER
Transfusion-related Acute Lung Injury in Patients With Liver Disease
Loading search results
Sponsor study identifier
interventional
50
1 country
2
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2015
Actual (reported)Study Completion
August 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
October 26, 2011
Actual (reported)October 28, 2011
Actual (reported)August 2015
Actual (reported)August 2015
Actual (reported)Mean change in PaO2/fraction of inspired oxygen (FiO2) ratio
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.
Enrollment to 6 hours after the cessation of the transfusion protocol (54 hours)
Bleeding complication (y/n)
120 hour from admission
Transfusion-related acute lung injury
enrollment to 54 hours post-enrollment
Transfuse plasma to High INR target. Plasma will be transfused to reach a target INR=2.5 for 48 hours while patient is actively bleeding.
Transfuse plasma to Low INR target. Plasma will be transfused to reach a target INR=1.8 for 48 hours while patient is actively bleeding.
Using a dosing algorithm we will bolus plasma to reach an INR target (2.5) while patient is actively bleeding or 48 hours whichever comes first
Using a dosing algorithm we will bolus plasma to reach an INR target (1.8) while patient is actively bleeding or 48 hours whichever comes first
University of Colorado Hospital
Aurora, Colorado, 80045, United States
Denver Health Hospitals
Denver, Colorado, 80204, United States
Benson AB, Austin GL, Berg M, McFann KK, Thomas S, Ramirez G, Rosen H, Silliman CC, Moss M. Transfusion-related acute lung injury in ICU patients admitted with gastrointestinal bleeding. Intensive Care Med. 2010 Oct;36(10):1710-1717. doi: 10.1007/s00134-010-1954-x. Epub 2010 Jul 24.
Marc Moss, MD
University of Colorado, Denver
50 participants (actual enrollment reported by the registry).
First Submitted
October 26, 2011
First Posted
October 28, 2011
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
28 day and ICU Mortality
enrollment to 28 days
ICU and Hospital length of Stay
days
Change in oxygen saturation (SPO2)/FiO2 ratio (∆S/F) before and after transfusion
enrollment to 54 hours post enrollment
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
August 2015
Actual (reported)Study Completion
August 2015
Actual (reported)Last Updated
March 27, 2017
Record last verified: 2017-03
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: