Trial · NCT04704869
Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation
NCT04704869, Phase 3, Completed, Bryan Cotton; results first posted 2023-02-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation. Trials, record NCT04704869. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04704869
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation
- NCT number
- NCT04704869
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,604 participants, actual
- Lead sponsor
- Bryan Cotton
- Conditions
- Trauma Injury
- Interventions
- Cryoprecipitate, Red Blood Cells, Plasma, Platelets, Whole Blood
- First posted
- 2021-01-12
- Last updated
- 2025-01-14
- Other registries' IDs
- isrctn:ISRCTN14998314
- Results first posted
- 2023-02-21
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Mortality From Any Cause | 28 days after emergency department (ED) admission | Mortality from any cause |
| Secondary | All Cause Mortality at 6 Hours | 6 hours after ED admission | Mortality from any cause |
| Secondary | All Cause Mortality at 24 Hours | 24 hours after ED admission | Mortality from any cause |
| Secondary | All Cause Mortality at 6 Months | 6 months after ED admission | Mortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated. |
| Secondary | All Cause Mortality at 12 Months | 12 months after ED admission | Mortality from any cause. All cause mortality at 6 months is presented as a Kaplan-Meier estimated. |
| Secondary | Death From Bleeding at 6 Hours | 6 hours after ED admission | Death related to exsanguination |
| Secondary | Death From Bleeding at 24 Hours | 24 hours after ED admission | Death related to exsanguination |
| Secondary | Transfusion Requirements (Number of Units of Red Blood Cells (RBCs)) | from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours | Number of units of RBCs |
| Secondary | Transfusion Requirements (Number of Units of Plasma) | from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours | Number of units of plasma |
| Secondary | Transfusion Requirements (Number of Units of Platelets) | from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours | Number of units of platelets |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Mortality From Any Cause | 28 days after emergency department (ED) admission | Vital status was not available from any source for 34 in the Massive Transfusion Protocol arm and 39 in the Early Cryoprecipitate plus Massive Transfusion Protocol arm. Data presented are from an intention to treat analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All Cause Mortality at 6 Hours | 6 hours after ED admission | Data were not collected for 15 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected for 10 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All Cause Mortality at 24 Hours | 24 hours after ED admission | Data were not collected for 16 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected for 11 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | All Cause Mortality at 6 Months | 6 months after ED admission | percentage of participants | NUMBER | |
| SECONDARY | All Cause Mortality at 12 Months | 12 months after ED admission | percentage of participants | NUMBER | |
| SECONDARY | Death From Bleeding at 6 Hours | 6 hours after ED admission | Data were not collected from 10 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 15 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Death From Bleeding at 24 Hours | 24 hours after ED admission | Data were not collected from 11 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 16 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Transfusion Requirements (Number of Units of Red Blood Cells (RBCs)) | from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours | Data were not collected from 108 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Units | MEDIAN |
| SECONDARY | Transfusion Requirements (Number of Units of Plasma) | from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours | Data were not collected from 108 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | units | MEDIAN |
| SECONDARY | Transfusion Requirements (Number of Units of Platelets) | from time of pre-hospital care to 24 hours after ED admission, an average of 30 hours | Data were not collected from 110 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 104 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. | Units | MEDIAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Mortality From Any Cause | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 201 | Participants | ||
| Number of Participants With Mortality From Any Cause | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 192 | Participants | ||
| All Cause Mortality at 6 Hours | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 56 | Participants | ||
| All Cause Mortality at 6 Hours | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 68 | Participants | ||
| All Cause Mortality at 24 Hours | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 88 | Participants | ||
| All Cause Mortality at 24 Hours | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 97 | Participants | ||
| All Cause Mortality at 6 Months | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 26.1 | 95% Confidence Interval 23.2 to 29.4 | percentage of participants | |
| All Cause Mortality at 6 Months | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 27.3 | 95% Confidence Interval 24.3 to 30.7 | percentage of participants | |
| All Cause Mortality at 12 Months | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 26.6 | 95% Confidence Interval 23.6 to 30.0 | percentage of participants | |
| All Cause Mortality at 12 Months | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 27.7 | 95% Confidence Interval 24.6 to 31.1 | percentage of participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 805 | |
| Overall Study | STARTED | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 799 | |
| Overall Study | Completed 28-day Follow up | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 771 | |
| Overall Study | Completed 28-day Follow up | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 760 | |
| Overall Study | COMPLETED | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 771 | |
| Overall Study | COMPLETED | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 760 | |
| Overall Study | NOT COMPLETED | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 34 | |
| Overall Study | NOT COMPLETED | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 39 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Venous thromboembolism | Vascular disorders | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 57 | 805 | 59 |
| serious | Venous thromboembolism | Vascular disorders | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 55 | 799 | 58 |
| serious | Arterial thrombotic event | Vascular disorders | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 26 | 805 | 26 |
| serious | Arterial thrombotic event | Vascular disorders | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 26 | 799 | 27 |
| serious | Serious transfusion related adverse event | General disorders | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 0 | 805 | 0 |
| serious | Serious transfusion related adverse event | General disorders | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 3 | 799 | 3 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 201 | 771 |
| Total, all-cause mortality | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 192 | 760 |
| Total, other adverse events | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 0 | 805 |
| Total, other adverse events | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 0 | 799 |
| Total, serious adverse events | Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 83 | 805 |
| Total, serious adverse events | Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) | 84 | 799 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37824155 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) vs Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood): All Cause Mortality at 24 Hours | Trial comparisons |
Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) vs Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood): Number of Participants With Mortality From Any Cause | Trial comparisons |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) vs Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood): All Cause Mortality at 6 Hours | Trial comparisons |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) vs Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood): Death From Bleeding at 6 Hours | Trial comparisons |
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) vs Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood): deaths from any cause | Trial comparisons |
| Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) vs Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood): Death From Bleeding at 24 Hours | Trial comparisons |
| Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) vs Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT04704869/results?page=2