Trials / Completed
CompletedNCT02822599
Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
The Role of Human Fibrinogen Concentrate (RiaSTAP) in Decreasing Blood Loss and the Need for Component Blood Therapy in Infants Undergoing Cardiopulmonary Bypass.
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital · Academic / Other
- Sex
- All
- Age
- 1 Day – 1 Year
- Healthy volunteers
- Not accepted
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.
Detailed description
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. RiaSTAP will be administered after termination of Cardiopulmonary Bypass (CPB) at a dose of 70 mg/kg, in a prospective, randomized, controlled study. We hypothesize that the administration of RiaSTAP in this manner will reduce peri-operative bleeding and transfusion requirements.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | RiaStAP | To decrease post-operative bleeding volume. |
| DRUG | Saline | Placebo consisting of normal saline 0.9% |
Timeline
- Start date
- 2017-06-01
- Primary completion
- 2019-08-26
- Completion
- 2020-12-24
- First posted
- 2016-07-04
- Last updated
- 2021-09-16
- Results posted
- 2021-09-16
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02822599. Inclusion in this directory is not an endorsement.