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Completed

NCT Number: NCT00458783

Red Cell Storage Duration and Outcomes in Cardiac Surgery

The purpose of this study is to determine whether length of storage of RBC is related to postoperative morbid outcomes in patients undergoing cardiac surgery.

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Key information

Conditions

Blood Transfusion Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

Subjects undergoing cardiac surgery will be randomized into one of two groups. Group A will receive transfused blood that has storage duration less than 14 days. Group B will receive transfused blood with a storage duration of more than 20 days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All primary and reoperative adult cardiac surgical patients undergoing cardiopulmonary bypass for coronary artery bypass grafting, coronary artery bypass grafting with a valve procedure, isolated valve procedures, ascending aortic aneurysm or dissection repair alone or combined with CABG and valve procedures

Exclusion criteria

  • Age less than 18 years
  • Descending thoracic aortic aneurysm repairs
  • Left or right ventricular assist devices
  • Those unable to receive blood for religious reasons

Treatment and study plan

Prolonged RBC storage

Biological

Transfusion with oldest available matching RBCs

Short RBC storage

Biological

Transfusion with youngest available matching RBCs

Primary outcomes

  1. Primary Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Morbid Outcomes in Patients Undergoing Cardiac Surgery.

    Time frame: 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.

  2. Effect of RBC Age on Occurrence of Mortality or Multisystem Organ Failure Events

    Time frame: 30 days post surgery

    Aim 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.

  3. Effect of RBC Age on Occurrence of Neurologic Events

    Time frame: 30 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.

  4. Effect of RBC Age on Occurrence of Pulmonary Events.

    Time frame: 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.

  5. Effect of RBC Age on Occurrence of Renal Failure

    Time frame: 30 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.

  6. Effect of RBC Age on Occurrence of Infection Events

    Time frame: 30 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.

  7. Effect of RBC Age on Occurrence of Atrial Fibrillation

    Time frame: 30 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.

  8. Effect of RBC Age on Occurrence of Asystole

    Time frame: 30 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.

  9. Effect of RBC Age on Occurrence of Gastrointestinal Events

    Time frame: 30 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.

  10. Effect of RBC Age on Occurrence of Any Reoperation

    Time frame: 30 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.

  11. Effect of RBC Age on Occurrence of Vascular Events

    Time frame: 30 days post surgery.

    Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Vascular events in Patients Undergoing Cardiac Surgery.

    Vascular events include dissection and limb ischemia.

Secondary outcomes

  1. Effect of RBC Age on Intensive Care Unit (ICU) Length of Stay.

    Time frame: The total hours from start to end in the Intensive Care Unit (ICU).

    Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Intensive Care Unit (ICU) Length of Stay in Patients Undergoing Cardiac Surgery.

  2. Effect of RBC Age on Postoperative Hospital Lengths of Stay.

    Time frame: The total days from start to end of the Hospital Stay.

    Aim is to Determine Whether Length of Storage of Red Blood Cells is Related to Postoperative Hospital Lengths of Stay in Patients Undergoing Cardiac Surgery.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Important dates

Study start
2007
Primary completion
2018
Study completion
2019
First posted
Apr 11, 2007
Registry last updated
Jun 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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