Comparison · NCT05523297-sae
Octaplex vs Frozen Plasma: 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. Octaplex vs Frozen Plasma: serious adverse events. Trial comparisons, record NCT05523297-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05523297-sae
On this page
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 | 0.362 | 0.3 | 0.428 | wilson | |
| Risk in group 2 | 0.473 | 0.407 | 0.541 | wilson | |
| Risk difference, group 1 minus group 2 | -0.112 | -0.204 | -0.0176 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.764 | 0.607 | 0.96 | log | |
| Odds ratio, group 1 over group 2 | 0.63 | 0.426 | 0.931 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Octaplex than on Frozen Plasma | 8.93 | 4.91 | 56.7 | 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 | Octaplex | Participants were administered Octaplex according to a recommended initial dose of 1,500 IU for patients weighing ≤60 kg and 2,000 IU for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (3,000 IU if ≤60 kg or 4,000 IU if \>60 kg).~Octaplex: Prothrombin complex concentrate | 77 | 213 | EG000 |
| Group 2 | Frozen Plasma | Participants were administered FP according to a recommended initial dose of 3 U for patients weighing ≤60 kg and 4 U for patients weighing \>60 kg. A second dose of IMP could be administered if the patient continued to have at least moderate bleeding and suspected coagulation deficiency (e.g., INR ≥1.5) after completion of the first dose, up to the maximum allowable dose (6 U if ≤60 kg or 8 U if \>60 kg).~Frozen Plasma Product, Human | 98 | 207 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From beginning of surgery to 30 days after surgery start
Source ClinicalTrials.gov
Trial
- Title
- Active-control Randomized Trial Comparing 4-factor Prothrombin Complex Concentrate With Frozen Plasma in Cardiac Surgery
- NCT number
- NCT05523297
- Phases
- PHASE3
- Conditions
- Bleeding Cardiac Surgery Patients
- Interventions
- Octaplex, Frozen Plasma Product, Human
- Lead sponsor
- Octapharma
- Results first posted
- 2025-08-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05523297?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
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT05523297-sae