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NCT02822599 · ClinicalTrials.gov registry record · Phase 4
Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
A Phase 4 study, sponsored by Nicklaus Children's Hospital f/k/a Miami Children's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
NCT02822599: Completed Phase 4 study, sponsored by Nicklaus Children's Hospital f/k/a Miami Children's Hospital.
NCT02822599 is a Phase 4 study that has completed, run by Nicklaus Children's Hospital f/k/a Miami Children's Hospital. The registered enrollment target is 30 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02822599, a Phase 4 study, has completed, sponsored by Nicklaus Children's Hospital f/k/a Miami Children's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
Study Summary
The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.
Primary Outcome
Primary outcome efficacy: Estimated blood loss (EBL); median; A transfusion algorithm was developed based on three previous studies, modified for pediatrics. Clinically significant bleeding requiring treatment was defined as a rate \>10 cc kg-1 hr-1 calculated every 15 minutes while in the OR, measured by blood in the suction canister. In cases of continued bleeding following randomization to HFC or placebo, cryoprecipitate was considered for fibrinogen \<200 mg/dL or FIBTEM MCF \<7 mm. Thereaft
Interventions
- DRUG Saline
- DRUG RiaStAP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2017-06-01 |
| Est. Completion | 2020-12-24 |
| Phase | Phase 4 |
What the finished NCT02822599 record still lists
NCT02822599 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Saline is the first listed.
NCT02822599 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02822599 about?
NCT02822599 is a clinical study titled "Human Fibrinogen Concentrate in Pediatric Cardiac Surgery". The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.
What is the current status of trial NCT02822599?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2017-06-01. Estimated completion is 2020-12-24.
What interventions are being tested in trial NCT02822599?
The interventions under investigation include: Saline (DRUG), RiaStAP (DRUG).
Who is sponsoring clinical trial NCT02822599?
This trial is sponsored by Nicklaus Children's Hospital f/k/a Miami Children's Hospital, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02822599's enrollment target sits among peer trials
30 1552nd of 2000 higher than 367 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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