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NCT01838863 · ClinicalTrials.gov registry record · Phase 2
Control of Major Bleeding After Trauma Study
A Phase 2 study, sponsored by Denver Health and Hospital Authority.
- Terminated
- Registry status
- Phase 2
- Development phase
- 144
- Enrollment target
NCT01838863: Clinical Trial Phase 2 study, sponsored by Denver Health and Hospital Authority.
NCT01838863 is a Phase 2 study that was terminated before completion, run by Denver Health and Hospital Authority. The registered enrollment target is 144 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01838863, a Phase 2 study, was terminated before completion, sponsored by Denver Health and Hospital Authority.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 144 participants
- Enrollment target
Study Summary
Bleeding is the most avoidable cause of death in trauma patients. Up to one-third of severely injured trauma patients are found to be coagulopathic and forty percent of the mortality following severe injury is due to uncontrollable hemorrhage in the setting of coagulopathy. It has been established that early administration of fresh frozen plasma decreases mortality following severe injury, replacing lost coagulation factors, improving the coagulopathy and restoring blood volume. This study will determine if giving plasma to severely injured trauma patients during ambulance transport versus after arrival to the hospital will help reduce hemorrhage, thus decreasing both total blood product administration and mortality.
Primary Outcome
death within 28 days post injury (death of any cause except for death due to a second, clearly unrelated traumatic injury suffered after discharge)
Interventions
- BIOLOGICAL Type AB plasma
- DRUG Crystalloid fluid (standard of care for resuscitation)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2014-04-07 |
| Est. Completion | 2017-04-03 |
| Phase | Phase 2 |
Why NCT01838863 stopped before completion
NCT01838863 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Type AB plasma is the first listed.
NCT01838863 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01838863 about?
NCT01838863 is a clinical study titled "Control of Major Bleeding After Trauma Study". Bleeding is the most avoidable cause of death in trauma patients. Up to one-third of severely injured trauma patients are found to be coagulopathic and forty percent of the mortality following severe injury is due to uncontrollable hemorrhage in the setting of coagulopathy. It has been established t...
What is the current status of trial NCT01838863?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 144 participants. The study started on 2014-04-07. Estimated completion is 2017-04-03.
What interventions are being tested in trial NCT01838863?
The interventions under investigation include: Type AB plasma (BIOLOGICAL), Crystalloid fluid (standard of care for resuscitation) (DRUG).
Who is sponsoring clinical trial NCT01838863?
This trial is sponsored by Denver Health and Hospital Authority, which has 73 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01838863's enrollment target sits among peer trials
144 500th of 2000 higher than 1,494 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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