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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: Clinical Trial Phase 3 study, sponsored by University of Colorado, Denver.
NCT01461889 is a Phase 3 study that was terminated before completion, run by University of Colorado, Denver. The registered enrollment target is 50 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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.
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 |
Why NCT01461889 stopped before completion
NCT01461889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Transfuse plasma to High INR target is the first listed.
NCT01461889 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01461889's enrollment target sits among peer trials
50 1844th of 2000 higher than 141 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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