Comparison · NCT02540434-sae
Cryopreciptiate Arm vs RiaSTAP Arm: 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. Cryopreciptiate Arm vs RiaSTAP Arm: serious adverse events. Trial comparisons, record NCT02540434-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02540434-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 | 0 | 0.793 | wilson | |
| Risk in group 2 | 0 | 0 | 0.793 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.793 | 0.793 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Cryopreciptiate Arm | Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present. ROTEM delta will be used to identify intraoperative coagulation abnormalities. Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate.~Only enrolled patients randomized to cryoprecipitate arm are at risk for cryoprecipitate-related adverse events. 1 subject out of total 22 consented were randomized to this arm, so 1 subject was at risk to adverse events from this arm. No events were reported. | 0 | 1 | EG000 |
| Group 2 | RiaSTAP Arm | Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen.~Only enrolled patients randomized to RiaSTAP are at risk for riastap-related adverse events. 0 subjects out of total 22 consented were randomized to this arm, so no subjects were at risk to adverse events from this arm. | 0 | 1 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Trial of RiaSTAP Versus Cryoprecipitate to Lower Operative Transfusions
- NCT number
- NCT02540434
- Phases
- NA
- Conditions
- Coagulopathy
- Interventions
- ROTEM, Cryoprecipitate, RiaSTAP
- Lead sponsor
- Weill Medical College of Cornell University
- Results first posted
- 2017-05-12
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02540434?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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