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Trial · NCT00458783

Red Cell Storage Duration and Outcomes in Cardiac Surgery

NCT00458783, Not applicable, Completed, The Cleveland Clinic; results first posted 2021-06-03

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Red Cell Storage Duration and Outcomes in Cardiac Surgery. Trials, record NCT00458783. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00458783

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Red Cell Storage Duration and Outcomes in Cardiac Surgery
NCT number
NCT00458783
Status
Completed
Phases
Not applicable
Enrollment
3,942 participants, actual
Lead sponsor
The Cleveland Clinic
Conditions
Blood Transfusion, Cardiac Surgery
Interventions
Prolonged RBC storage, Short RBC storage
First posted
2007-04-11
Last updated
2021-06-03
Results first posted
2021-06-03

Source ClinicalTrials.gov

Registered outcomes13

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

ListOutcomeTime frameDescription
PrimaryPrimary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery.30 days post surgery.
The primary composite endpoint was the occurrence of mortality or multisystem organ failure, cardiac events (ventricular tachycardia, fibrillation, or asystole; atrial fibrillation), pulmonary events (pneumonia, prolonged postoperative ventilation, pulmonary embolus), neurologic events (stroke, coma), renal failure, infection (deep sternal wound infection, sepsis), gastrointestinal events (ischemia, infarction), any reoperation (for bleeding, tamponade, cardiac dysfunction), and vascular events (dissection, limb ischemia), as defined for the STS database.
PrimaryEffect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events30 days post surgeryAim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Mortality or Multisystem Organ Failure events in Patients Undergoing Cardiac Surgery.
PrimaryEffect of RBC Age on Occurrence of Neurologic Events30 days post surgery.
Neurologic events includes stroke and coma. Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Mortality or Neurologic events in Patients Undergoing Cardiac Surgery.
PrimaryEffect of RBC Age on Occurrence of Pulmonary Events.30 days post surgery.
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Pulmonary events in Patients Undergoing Cardiac Surgery. Pulmonary events include pneumonia, prolonged postoperative ventilation and pulmonary embolus.
PrimaryEffect of RBC Age on Occurrence of Renal Failure30 days post surgery.Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Renal Failure in Patients Undergoing Cardiac Surgery.
PrimaryEffect of RBC Age on Occurrence of Infection Events30 days post surgery.
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Infection events in Patients Undergoing Cardiac Surgery. Infection events include deep sternal wound infection and sepsis.
PrimaryEffect of RBC Age on Occurrence of Atrial Fibrillation30 days post surgery.Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Atrial fibrillation in Patients Undergoing Cardiac Surgery.
PrimaryEffect of RBC Age on Occurrence of Asystole30 days post surgery.Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Asystole in Patients Undergoing Cardiac Surgery.
PrimaryEffect of RBC Age on Occurrence of Gastrointestinal Events30 days post surgery.
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Gastrointestinal events in Patients Undergoing Cardiac Surgery. Gastrointestinal events include ischemia and infarction.
PrimaryEffect of RBC Age on Occurrence of Any Reoperation30 days post surgery.
Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to any Postoperative Reoperation in Patients Undergoing Cardiac Surgery. Reoperation for bleeding, tamponade and cardiac dysfunction.

Outcomes13

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPrimary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery.30 days post surgery.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYEffect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events30 days post surgeryParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYEffect of RBC Age on Occurrence of Neurologic Events30 days post surgery.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYEffect of RBC Age on Occurrence of Pulmonary Events.30 days post surgery.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYEffect of RBC Age on Occurrence of Renal Failure30 days post surgery.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYEffect of RBC Age on Occurrence of Infection Events30 days post surgery.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYEffect of RBC Age on Occurrence of Atrial Fibrillation30 days post surgery.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYEffect of RBC Age on Occurrence of Asystole30 days post surgery.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYEffect of RBC Age on Occurrence of Gastrointestinal Events30 days post surgery.ParticipantsCOUNT_OF_PARTICIPANTS
PRIMARYEffect of RBC Age on Occurrence of Any Reoperation30 days post surgery.ParticipantsCOUNT_OF_PARTICIPANTS

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery.Prolonged RBC Storage360Participants
Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery.Short RBC Storage362Participants
Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure EventsProlonged RBC Storage24Participants
Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure EventsShort RBC Storage16Participants
Effect of RBC Age on Occurrence of Neurologic EventsProlonged RBC Storage19Participants
Effect of RBC Age on Occurrence of Neurologic EventsShort RBC Storage14Participants
Effect of RBC Age on Occurrence of Pulmonary Events.Prolonged RBC Storage113Participants
Effect of RBC Age on Occurrence of Pulmonary Events.Short RBC Storage106Participants
Effect of RBC Age on Occurrence of Renal FailureProlonged RBC Storage36Participants
Effect of RBC Age on Occurrence of Renal FailureShort RBC Storage32Participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDProlonged RBC Storage1,914
Overall StudySTARTEDShort RBC Storage1,921
Overall StudyCOMPLETEDProlonged RBC Storage686
Overall StudyCOMPLETEDShort RBC Storage701
Overall StudyNOT COMPLETEDProlonged RBC Storage1,228
Overall StudyNOT COMPLETEDShort RBC Storage1,220

Adverse events30

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
seriousMultisystem organ failureGeneral disordersProlonged RBC Storage3686
seriousMultisystem organ failureGeneral disordersShort RBC Storage3701
seriousStrokeNervous system disordersProlonged RBC Storage6686
seriousStrokeNervous system disordersShort RBC Storage7701
seriousComaNervous system disordersProlonged RBC Storage14686
seriousComaNervous system disordersShort RBC Storage9701
seriousPneumoniaRespiratory, thoracic and mediastinal disordersProlonged RBC Storage14686
seriousPneumoniaRespiratory, thoracic and mediastinal disordersShort RBC Storage9701
seriousProlonged ventilationRespiratory, thoracic and mediastinal disordersProlonged RBC Storage107686
seriousProlonged ventilationRespiratory, thoracic and mediastinal disordersShort RBC Storage99701

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityProlonged RBC Storage23686
Total, all-cause mortalityShort RBC Storage15701
Total, other adverse eventsProlonged RBC Storage0686
Total, other adverse eventsShort RBC Storage0701
Total, serious adverse eventsProlonged RBC Storage360686
Total, serious adverse eventsShort RBC Storage362701

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
23874777DERIVED

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 comparisons13

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Prolonged RBC Storage vs Short RBC Storage: Effect of RBC Age on Occurrence of Atrial FibrillationTrial comparisons
Prolonged RBC Storage vs Short RBC Storage: Effect of RBC Age on Occurrence of Infection EventsTrial comparisons
Prolonged RBC Storage vs Short RBC Storage: Effect of RBC Age on Occurrence of Vascular EventsTrial comparisons
Prolonged RBC Storage vs Short RBC Storage: Effect of RBC Age on Occurrence of Neurologic EventsTrial comparisons
Prolonged RBC Storage vs Short RBC Storage: Effect of RBC Age on Occurrence of AsystoleTrial comparisons
Prolonged RBC Storage vs Short RBC Storage: Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery.Trial comparisons
Prolonged RBC Storage vs Short RBC Storage: Effect of RBC Age on Occurrence of Renal FailureTrial comparisons
Prolonged RBC Storage vs Short RBC Storage: Effect of RBC Age on Occurrence of Gastrointestinal EventsTrial comparisons
Prolonged RBC Storage vs Short RBC Storage: Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure EventsTrial comparisons
Prolonged RBC Storage vs Short RBC Storage: Effect of RBC Age on Occurrence of Any ReoperationTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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.

GET https://conductscience.org/api/trials/v1/NCT00458783

GET https://conductscience.org/api/trials/v1/NCT00458783/results?page=2