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Trial · NCT03229538

Outcomes13

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Participants at Each Global Rank Endpoint Based Upon Their Most-severe OutcomeUntil hospital discharge, up to 4 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Mortality, Including In-hospital Mortality or Mortality After Hospital Discharge But Within 30 Days of the Last Dose of Study Drugup to 30 daysParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Death or Major Complication as Defined by an Outcome in One of the 7 Highest Global Ranking CategoriesUntil hospital discharge, up to 4 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With a Post-operative Length of Stay Greater Than 90 DaysUntil hospital discharge, up to 4 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Prolonged Mechanical Ventilation (Greater Than 7 Days)Until hospital discharge, up to 4 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Post-operative Low Cardiac Output SyndromeUntil hospital discharge, up to 4 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARY
Number of Participants With Occurrence of Any One or More of the Following STS-CHSD-defined Major Post-operative Infectious Complications: Postprocedural Infective Endocarditis, Pneumonia, Sepsis, Deep Wound Infection, Mediastinitis.
Until hospital discharge, up to 4 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYNumber of Participants With Any Other Post-operative Complications From the Start of Study Drug Administration Until Hospital Discharge.Until hospital discharge, up to 4 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPK/PD - Time to Maximum Concentration (Tmax)
Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB)
Data not collected.
SECONDARYPK/PD - Maximum Concentration (Cmax)
Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB)
Data not collected.
SECONDARYPK/PD - Clearance (CL)
Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB)
Data not collected.
SECONDARYPK/PD - Volume of Distribution (Vd)
Pre-2nd dose and minimum of 2 of any of the following 5 time points (0-30 minutes after the start of CPB, 0-30 minutes after MUF, 1-2 hours after completion of CPB, 4-6 hours after completion of CPB, or 16-24 hours after completion of CPB)
Data not collected.
SECONDARYPost-operative Biomarkers of the Inflammatory Response to Cardiopulmonary Bypass Including Interleukins 6 and 8
Pre-2nd dose; a minimum of 2 of any of the following 5 time points (0-30 min after the start of CPB, 0-30 min after MUF, 1-2 hrs after CPB end, 4-6 hrs after CPB end, or 16-24 hrs after CPB end); and 36-48 hrs after CPB end
Data not collected.

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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