Comparison · NCT03932240-sae
Fibrinogen Concentrate (FC) vs Cryoprecipitate: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Fibrinogen Concentrate (FC) vs Cryoprecipitate: serious adverse events. Trial comparisons, record NCT03932240-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03932240-sae
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.111 | 0.031 | 0.328 | wilson | |
| Risk in group 2 | 0.5 | 0.29 | 0.71 | wilson | |
| Risk difference, group 1 minus group 2 | -0.389 | -0.613 | -0.0872 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.222 | 0.0556 | 0.889 | log | |
| Odds ratio, group 1 over group 2 | 0.125 | 0.022 | 0.709 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Fibrinogen Concentrate (FC) than on Cryoprecipitate | 2.57 | 1.63 | 11.5 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Fibrinogen Concentrate (FC) | Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and fibrinogen concentrate after separation from bypass. | 2 | 18 | EG000 |
| Group 2 | Cryoprecipitate | Neonates undergoing elective cardiac surgery requiring cardiopulmonary bypass (CPB) who were randomized to receive platelets and cryoprecipitate after separation from bypass. | 9 | 18 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Information on serious and non-serious adverse events was collected beginning at the time consent to participate in the study was given through 7 days post-surgery. Mortality was collected until the participant was discharged from the hospital (up to 150 days).
Source ClinicalTrials.gov
Trial
- Title
- In Vivo Effects of Fibrinogen Concentrate (FC) Versus Cryoprecipitate on the Neonatal Fibrin Network Structure After Cardiopulmonary Bypass (CPB)
- NCT number
- NCT03932240
- Phases
- PHASE3
- Conditions
- Hemostasis
- Interventions
- Fibrinogen Concentrate (FC), Cryoprecipitate
- Lead sponsor
- Emory University
- Results first posted
- 2023-03-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03932240?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
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