Comparison · NCT02557672-sae
Fresh Frozen Plasma vs Prothrombin Complex Concentrate: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Fresh Frozen Plasma vs Prothrombin Complex Concentrate: serious adverse events. Trial comparisons, record NCT02557672-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02557672-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 | 0.898 | 0.782 | 0.956 | wilson | |
| Risk in group 2 | 0.882 | 0.766 | 0.945 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0156 | -0.116 | 0.145 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.02 | 0.887 | 1.17 | log | |
| Odds ratio, group 1 over group 2 | 1.17 | 0.334 | 4.13 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Fresh Frozen Plasma than on Prothrombin Complex Concentrate | 64.1 | from the risk difference interval | the interval includes no difference |
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 | Fresh Frozen Plasma | After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received fresh frozen plasma as this is standard therapy per our institutional algorithm at a dose of 10-15 mL/kg rounded up to the nearest unit.~Fresh frozen plasma (FFP): FFP | 44 | 49 | EG000 |
| Group 2 | Prothrombin Complex Concentrate | After cardiopulmonary bypass, patients received protamine at dose 0.01 mg/unit of heparin given with target activated clotting time (ACT) within 10% of baseline value. After protamine administration the ACT, complete blood count (CBC), prothrombin time (PT)/ international normalized ratio (INR), activated partial thromboplastin time (APTT), and fibrinogen, were collected via preexisting arterial access. If ACT \>10% baseline additional protamine was given at the anesthesiologists discretion. Evaluation and determination of excessive microvascular bleeding in the surgical field occurred 10 minutes after return of ACT to within 10% of baseline. Patients with clinical evidence of excessive microvascular bleeding in the surgical field as determined by the surgical team, along with a PT \>16.6 sec/ INR \>1.6 sec received Prothrombin complex concentrate (Human) 15 units/kg.~Prothrombin complex concentrate (Human): PCC (Kcentra) | 45 | 51 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse Events were collected for each subject from baseline to end of study, approximately 30 days
Source ClinicalTrials.gov
Trial
- Title
- PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
- NCT number
- NCT02557672
- Phases
- PHASE4
- Conditions
- Bleeding, Blood Loss, Surgical, Cardiovascular Surgical Procedures, Prothrombin Complex Concentrates, Fresh Frozen Plasma
- Interventions
- Prothrombin complex concentrate (Human), Fresh frozen plasma (FFP)
- Lead sponsor
- Mayo Clinic
- Results first posted
- 2022-06-07
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02557672?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.
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