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Trial · NCT04704869

Outcomes19

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants With Mortality From Any Cause28 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.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYAll Cause Mortality at 6 Hours6 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.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYAll Cause Mortality at 24 Hours24 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
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYAll Cause Mortality at 6 Months6 months after ED admissionpercentage of participantsNUMBER
SECONDARYAll Cause Mortality at 12 Months12 months after ED admissionpercentage of participantsNUMBER
SECONDARYDeath From Bleeding at 6 Hours6 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.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYDeath From Bleeding at 24 Hours24 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.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYTransfusion 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.
UnitsMEDIAN
SECONDARYTransfusion 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.
unitsMEDIAN
SECONDARYTransfusion 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.
UnitsMEDIAN
SECONDARYTransfusion Requirements (Number of Units of Cryoprecipitate)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.
UnitsMEDIAN
SECONDARYDestination of Participant at Time of Discharge From Hospitalat the time of discharge from hospital, about 11-27 days after admission
Data were not collected from 431 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 424 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYQuality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)Day of hospital discharge or 28 days after ED admission (whichever comes first)
Data were not collected from 458 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 475 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
score on a scaleMEDIAN
SECONDARYQuality of Life as Assessed by the Glasgow Outcome ScoreDay of hospital discharge or 28 days after ED admission (whichever comes first)
Data were not collected from 93 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 94 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYQuality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ5D-5L)6 months after ED admission
Data were not collected from 350 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 331 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
score on a scaleMEDIAN
SECONDARYQuality of Life as Assessed by the Glasgow Outcome Score6 months after ED admission
Data for this outcome measure were not collected because the survey was not included on the 6-month follow-up. As a result, no participants received the survey, and therefore, no participants were analyzed in either study arm.
SECONDARYHospital Resource Use as Assessed by Number of Ventilator DaysDay of hospital discharge or 28 days after ED admission (whichever comes first)
Data were not collected from 34 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 36 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
daysMEDIAN
SECONDARYHospital Resource Use as Assessed by Number of Intensive Care Unit (ICU) DaysDay of hospital discharge or 28 days after ED admission (whichever comes first)
Data were not collected from 34 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 36 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
daysMEDIAN
SECONDARYHospital Resource Use as Assessed by Number of Hospital DaysDay of hospital discharge or 28 days after ED admission (whichever comes first)
Data were not collected from 33 participants in the Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm. Data were not collected from 36 participants in the Early Cryoprecipitate + Massive Transfusion Protocol (RBCs, Plasma, Platelets, Whole Blood) arm.
daysMEDIAN

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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