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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 is a Phase 2 study that was terminated before completion, run by Denver Health and Hospital Authority. The registered enrollment target is 144 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01838863
The ClinicalTrials.gov registry entry for NCT01838863 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Denver Health and Hospital Authority, which has 73 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Type AB plasma is the first listed.
NCT01838863 reports 0 study locations.
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.
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