Comparison · NCT00708435-a36eb05b
Beriplex® P/N vs Fresh Frozen Plasma: 45-Day All-cause Mortality
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. Beriplex® P/N vs Fresh Frozen Plasma: 45-Day All-cause Mortality. Trial comparisons, record NCT00708435-a36eb05b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00708435-a36eb05b
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 | 0.0918 | 0.0491 | 0.165 | wilson | |
| Risk in group 2 | 0.0481 | 0.0207 | 0.108 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0438 | -0.0296 | 0.122 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.91 | 0.663 | 5.5 | log | |
| Odds ratio, group 1 over group 2 | 2 | 0.647 | 6.2 | log | |
| Number needed to treat, for one more participant with the outcome on Beriplex® P/N than on Fresh Frozen Plasma | 22.9 | 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 | Beriplex® P/N | Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body weight | 9 | 98 | OG000 |
| Group 2 | Fresh Frozen Plasma | Fresh frozen plasma: Intravenous Infusion, dosage depending on baseline INR and body weight | 5 | 104 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- 45-Day All-cause Mortality
- Description
- Time frame
- Until Day 45
- Population
The ITT-E population included all randomized participants who had received any study product, presented with acute major bleeding, and had an INR \> 1.3 prior to the infusion. Participants in the ITT-E population were analyzed 'as randomized'.
Source ClinicalTrials.gov
Trial
- Title
- Efficacy and Safety Study of BERIPLEX® P/N (Kcentra) Compared With Plasma in Patients With Acute Major Bleeding Caused by Anticoagulant Therapy
- NCT number
- NCT00708435
- Phases
- PHASE3
- Conditions
- Blood Coagulation Disorders, Acute Major Bleeding
- Interventions
- Beriplex® P/N (Kcentra), Fresh frozen plasma
- Lead sponsor
- CSL Behring
- Results first posted
- 2013-08-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00708435?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/NCT00708435-a36eb05b