Phase 4
N=30
Human Fibrinogen Concentrate in Pediatric Cardiac Surgery
Hypofibrinogenemia · Afibrinogenemia · Bleeding Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02822599 ↗Enrolled (actual)
30
Serious AEs
40.0%
Results posted
Sep 2021
Primary outcome: Primary: Postoperative Blood Loss After Surgery (Estimated Blood Loss (EBL)) — 35; 33 cc/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- RiaStAP (Drug); Saline (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Blood Loss After Surgery (Estimated Blood Loss (EBL)) |
35; 33 | — |
| PRIMARY Post-operative 2 hr Hemoglobin (Hg) mg/dL Measure |
13.6; 12.5 | — |
| PRIMARY Post-operative 24-hr Hemoglobin (Hg) mg/dL |
13.8; 12.4 | — |
| PRIMARY Post-operative 2 hr Hematocrit (HCT) Measure |
40.9; 35.9 | — |
| PRIMARY Post-operative 24 hr Hematocrit (HCT) Measure |
38.9; 35.4 | — |
| PRIMARY Post-operative 2 hr Platelets Count Test (PLT) 10K/uL |
282.0; 224.0 | — |
| PRIMARY Post-operative 24 hr Platelets Count Test (PLT) 10K/uL |
249.0; 247.0 | — |
| PRIMARY Post-operative 2 hr Prothrombin (PT) Seconds |
17.0; 16.5 | — |
| PRIMARY Post-operative 24 hr Prothrombin (PT) Seconds |
16.0; 16.1 | — |
| PRIMARY Post-operative 2 hr International Normalize Ratio (INR) |
1.4; 1.4 | — |
| PRIMARY Post-operative 24 hr International Normalize Ratio (INR) |
1.3; 1.3 | — |
| PRIMARY Post-operative 2 hr Partial Thromboplastin Time (PTT) Seconds |
36.7; 35.2 | — |
| PRIMARY Post-operative 24 hr Partial Thromboplastin Time (PTT) Seconds |
35.5; 31.5 | — |
| PRIMARY Post-operative 2 hr Fibrinogen mg/dL |
258.0; 330.0 | — |
| PRIMARY Post-operative 24 hr Fibrinogen mg/dL |
416.5; 403.0 | — |
| SECONDARY Post-Operative Respiratory Failure Adverse Events |
3; 3 | — |
| SECONDARY Post-operative Thrombus Adverse Events |
4; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Neonatal and infant cardiac patients presenting for open-heart surgery at Nicklaus Children's Hospital will be eligible for enrollment in the study.
Exclusion Criteria
- Patients who fall outside of the age range for the study will be excluded. Patients known to have had an anaphylactic or severe reaction to the drug or its components will not be enrolled. At the time of the rewarming ROTEM, any patient with a FIBTEM MCF > 15mm, will be excluded.
Data sourced from ClinicalTrials.gov (NCT02822599). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.