Comparison · NCT04704869-sae
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) vs Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood): 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. Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) vs Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood): serious adverse events. Trial comparisons, record NCT04704869-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04704869-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 | 0.103 | 0.0839 | 0.126 | wilson | |
| Risk in group 2 | 0.105 | 0.0857 | 0.128 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00203 | -0.0321 | 0.028 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.981 | 0.736 | 1.31 | log | |
| Odds ratio, group 1 over group 2 | 0.979 | 0.71 | 1.35 | log | |
Number needed to treat, for one fewer participant with a serious adverse event on Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) than on Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 494 | 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 | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Only standard of care massive transfusion protocol products will be given, including red blood cells, plasma, platelets, and whole blood.~Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.~Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.~Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.~Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control. | 83 | 805 | EG000 |
| Group 2 | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | Cryoprecipitate will be given in addition to the standard of care massive transfusion protocol products, which include red blood cells, plasma, platelets and whole blood. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).~Cryoprecipitate: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).~Red Blood Cells: RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.~Plasma: Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.~Platelets: Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.~Whole Blood: Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control. | 84 | 799 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Day of hospital discharge or 28 days after ED admission (whichever comes first)
Source ClinicalTrials.gov
Trial
- Title
- Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation
- NCT number
- NCT04704869
- Phases
- PHASE3
- Conditions
- Trauma Injury
- Interventions
- Cryoprecipitate, Red Blood Cells, Plasma, Platelets, Whole Blood
- Lead sponsor
- Bryan Cotton
- Results first posted
- 2023-02-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04704869?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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