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NCT01903863 · ClinicalTrials.gov registry record · NA
The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity
A NA study of Extracorporeal Membrane Oxygenation, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT01903863 is a NA study of Extracorporeal Membrane Oxygenation that has completed, run by Duke University. The registered enrollment target is 31 participants, below the 271-participant average among 5 other Extracorporeal Membrane Oxygenation trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01903863, a NA study of Extracorporeal Membrane Oxygenation, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the impact of scheduled fresh frozen plasma (FFP) administration on extracorporeal membrane oxygenation (ECMO) pump longevity in critically ill pediatric and neonatal patients. Almost all ECMO patients receive multiple FFP transfusions during their ECMO course. The investigator proposes that scheduled FFP may maintain pro and anticoagulation balance thus mitigating the need for expensive and dangerous ECMO pump changes. In addition, this may lead to less overall transfusion with all products (red blood cells, platelets, and FFP) if coagulation homeostasis is maintained. The subjects will be neonatal and pediatric patients requiring ECMO support for any reason in the pediatric and pediatric cardiac critical care units. Subjects will be randomized to receive every other day FFP infusions or FFP administration per current standard of care. ECMO pump longevity (hours) and FFP use will be compared between the two groups There is a small risk that study subjects may receive more FFP transfusions and therefore have the increased associated risks however it is also possible that these subjects may benefit from less ECMO circuit changes and/or fewer transfusions of all blood products.
Conditions Studied
Interventions
- BIOLOGICAL Fresh frozen plasma
Study Locations (1)
North Carolina
- Duke University Medical Center PICU and PCICU - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-04 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01903863
The ClinicalTrials.gov registry entry for NCT01903863 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 271-participant average among 5 other Extracorporeal Membrane Oxygenation trials with a reported enrollment target (89% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Extracorporeal Membrane Oxygenation appearing as the primary indexed condition, and to 1 intervention - of which Fresh frozen plasma is the first listed.
NCT01903863 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT01903863 about?
NCT01903863 is a clinical study titled "The Effect of Prophylactic FFP Administration on ECMO Circuit Longevity". The purpose of this study is to assess the impact of scheduled fresh frozen plasma (FFP) administration on extracorporeal membrane oxygenation (ECMO) pump longevity in critically ill pediatric and neonatal patients. Almost all ECMO patients receive multiple FFP transfusions during their ECMO course....
What is the current status of trial NCT01903863?
This trial is currently completed. It is a NA study. The enrollment target is 31 participants. The study started on 2013-07. Estimated completion is 2016-04.
What conditions does trial NCT01903863 study?
This clinical trial studies the following conditions: Extracorporeal Membrane Oxygenation.
What interventions are being tested in trial NCT01903863?
The interventions under investigation include: Fresh frozen plasma (BIOLOGICAL).
Who is sponsoring clinical trial NCT01903863?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01903863 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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