Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03014700 · ClinicalTrials.gov registry record · Phase 4
Fibrinogen Concentrate vs Cryoprecipitate
A Phase 4 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT03014700: Completed Phase 4 study, sponsored by Stanford University.
NCT03014700 is a Phase 4 study that has completed, run by Stanford University. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03014700, a Phase 4 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
One of the most common hemostatic derangements in pediatric open- heart surgery is an acute acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet aggregation, resulting in increased bleeding and allogenic blood transfusions. Currently, fresh frozen plasma and cryoprecipitate are used to supplement fibrinogen in pediatric cardiac patients. We propose that replacing cryoprecipitate with fibrinogen concentrate will be as effective in treating post-CPB bleeding and will decrease total blood product exposure when used as part of a blood transfusion algorithm. We plan to include all patients undergoing cardiac surgery on CPB less than 12 months and a fibrinogen level \<250mg/dL while on bypass. We hope to demonstrate that fibrinogen concentrate is at least as effective as the standard of care in the management of peri- operative bleeding in neonatal patients undergoing cardiopulmonary bypass. If we are able to demonstrate that fibrinogen is at least as effective as the standard of care, then we would plan a multi-center trial to demonstrate the safety and efficacy of this medication. If we are able to demonstrate that fibrinogen concentrate is effective, fibrinogen concentrate could replace allogenic products and potentially decrease transfusion related morbidity in mortality in this population.
Interventions
- BIOLOGICAL Cryoprecipitate
- BIOLOGICAL Fibrinogen Concentrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2016-03 |
| Est. Completion | 2018-04-25 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03014700
The ClinicalTrials.gov registry entry for NCT03014700 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cryoprecipitate is the first listed.
NCT03014700 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03014700 about?
NCT03014700 is a clinical study titled "Fibrinogen Concentrate vs Cryoprecipitate". One of the most common hemostatic derangements in pediatric open- heart surgery is an acute acquired hypofibrinogenemia. This compromises fibrin clot generation and platelet aggregation, resulting in increased bleeding and allogenic blood transfusions. Currently, fresh frozen plasma and cryoprecipi...
What is the current status of trial NCT03014700?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2016-03. Estimated completion is 2018-04-25.
What interventions are being tested in trial NCT03014700?
The interventions under investigation include: Cryoprecipitate (BIOLOGICAL), Fibrinogen Concentrate (BIOLOGICAL).
Who is sponsoring clinical trial NCT03014700?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.