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NCT01461889 · ClinicalTrials.gov registry record · Phase 3
INR-Triggered Transfusion In GI Bleeders From ER
A Phase 3 study, sponsored by University of Colorado, Denver.
- Terminated
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
NCT01461889 is a Phase 3 study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 50 participants.
The verdict
NCT01461889, a Phase 3 study, was terminated before completion, sponsored by University of Colorado, Denver.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
Study 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.
Interventions
- OTHER Transfuse plasma to High INR target
- OTHER Transfuse plasma to Low INR target
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-07 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01461889
The ClinicalTrials.gov registry entry for NCT01461889 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Transfuse plasma to High INR target is the first listed.
NCT01461889 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01461889 about?
NCT01461889 is a clinical study titled "INR-Triggered Transfusion In GI Bleeders From ER". 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...
What is the current status of trial NCT01461889?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2011-07. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01461889?
The interventions under investigation include: Transfuse plasma to High INR target (OTHER), Transfuse plasma to Low INR target (OTHER).
Who is sponsoring clinical trial NCT01461889?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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