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Trial · NCT04684719

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primary30-day mortalityEnrollment through 30 daysAll cause mortality within 30 days
SecondaryAge of whole bloodDuring ProcedureAge of units of whole blood in days categorized into young (1-14 days) and old (\>14 days) and compared across primary and secondary outcomes
Secondary3-hour mortalityEnrollment through 3 hoursDeath within 3 hours of enrollment
Secondary6-hour mortalityEnrollment through 6 hoursDeath within 6 hours of enrollment
Secondary24-hour mortalityEnrollment through 24 hoursDeath within 24 hours of enrollment
SecondaryIn-hospital mortalityEnrollment through hospital discharge or 30 daysDeath prior to hospital discharge
SecondaryTime to deathEnrollment through death or 30 daysTime in days from enrollment to death
SecondaryBlood and blood component transfusion typeEnrollment through 24 hoursType of blood or blood component required for transfusion
SecondaryBlood and blood component transfusion amountEnrollment through 24 hoursNumber of units of blood or blood component transfused
SecondaryTime to blood and blood component transfusionEnrollment time to first transfusionAmount of time from enrollment to transfusion of blood or blood component
SecondaryMultiple Organ Failure (MOF)Enrollment through 7 days or ICU discharge
Organ dysfunction will be evaluated via the Denver Post-injury Multiple Organ Failure Score. Patients who are never admitted to the Intensive Care Unit (ICU) or those with a length of ICU stay of less than 48 hours will be considered to have a Denver score of 0. A summary of the Denver score may be calculated by summing the worst scores of each of the individual systems over the course of the ICU stay. A summary Denver score \> 3 will be classified as MOF.
SecondaryHospital-acquired pneumoniaNumber of participants who develop pneumonia through 30 daysPneumonia acquired during hospitalization per Center for Disease Control (CDC) criteria
Secondaryblood stream infectionNumber of participants who develop blood stream infection through 30 daysBlood stream infection during hospitalization per CDC criteria
SecondaryAcute Respiratory Distress Syndrome (ARDS)Number of participants who develop ARDS through 30 days
The Berlin definition for mild ARDS (PaO2/FIO2, ≤ 300 mm Hg + timing, imaging and origin criteria) will be utilized as a threshold value to determine the incidence of ARDS and will be further stratified into Moderate (PaO2/FIO2, ≤ 200 mm Hg) and Severe (PaO2/FIO2, ≤ 100 mm Hg).
SecondaryProthrombin Time (PT)Enrollment through 60 minutes and 24 hoursMeasurement of platelet hemostatic function
SecondaryInternational Normalized Ratio (INR)Enrollment through 60 minutes and 24 hoursMeasurement of platelet hemostatic function
SecondaryIncidence of coagulopathy by rapid thrombelastography (rTEG)Enrollment through 60 minutes and 24 hoursCoagulopathy as indicated by rTEG measures
SecondaryrTEG platelet functionEnrollment through 60 minutes and 24 hoursrTEG measurement of platelet hemostatic function
SecondaryTime to hemostasisEnrollment through 4 hoursAbility to reach nadir transfusion requirement of 1 unit of red blood cells in a 60-minute time period in the first 4 hours following arrival
SecondaryTransfusion reactionEnrollment through 24 hoursAny transfusion complication

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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