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NCT Number: NCT00991341

Red Cell Storage Duration Study

The RECESS study will compare the effects of transfusing red blood cell units stored <= 10 days vs. red blood cell units stored >= 21 days, in patients who are undergoing complex cardiac surgery and are likely to need a red blood cell transfusion. The primary hypothesis is that there is a clinically important difference between the effects of shorter-storage red cell units and longer-storage red cell units on clinical outcomes and mortality risk.

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Key information

Conditions

Cardiac Surgery Erythrocyte Transfusion

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Florida, Gainesville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • >= 12 years old
  • >= 40 kg body weight
  • Scheduled complex cardiac surgery with planned use of median sternotomy.
  • Patients ≥ 18 years must have a Transfusion Risk Understanding Scoring Tool (TRUST) probability score ≥ 3

Exclusion criteria

  • Refusal of blood products
  • Planned surgery is minimally invasive
  • Known transfusion reaction history
  • Requirement for washed products, volume reduced products, or products with additive solution removed
  • Expected residual cyanosis with O2 saturation < 90
  • Left ventricular assist device (LVAD) or Extracorporeal membrane oxygenation (ECMO) support pre-operatively or planned need post-operatively
  • Cardiogenic shock requiring pre-operative placement of an Intra-aortic balloon pump (IABP) (IABP done for unstable angina or prophylactically for low ejection fraction is not excluded)
  • Planned Deep Hypothermic Circulatory Arrest (DHCA)
  • Renal dysfunction requiring pre-operative renal replacement therapies such as hemodialysis (HD) or continuous venovenous hemofiltration (CVVH)
  • Planned use of alternative to heparin, e.g. bivalirudin
  • Planned use of autologous or directed donations
  • Prior RBC transfusion during hospitalization for the study-qualifying surgery
  • Prior randomization into the RECESS study

Treatment and study plan

Red blood cell units stored <= 10 days

Biological

Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Red blood cell units stored >= 21 days

Biological

Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations.

Primary outcomes

  1. The Change in the Composite Multiple Organ Dysfunction Score (MODS) From the Pre-operative Baseline. The Worst Post-operative Values of Each Component of MODS Will be Used to Calculate the Change in MODS.

    Time frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first

    The follow-up MODS used to calculate 7-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 7, hospital discharge, or death, whichever occurred first, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored [subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation], then a post-op MODS score was set to missing and a 7-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).

Secondary outcomes

  1. All-cause Mortality

    Time frame: 28 days post-surgery

    Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed for all-cause mortality until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analysis started at randomization.

  2. Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.

    Time frame: Through 28 days post-surgery, hospital discharge, or death, whichever occurs first

    The follow-up MODS used to calculate 28-day ΔMODS from pre-op baseline was based on the worst value of each component of MODS observed through post-op day 28, hospital discharge, or death, whichever occurred first, even if a subject's worst values for different components occurred on different dates. Subjects who died during this time period were assigned the worst possible follow-up MODS score, 24 points, and each component of MODS was set at 4, which is the worst score. If a subject did not die during this time period but had at least one day where the Glasgow Coma Score couldn't be scored[subject sedated; neurologic function not normal by pre-op history (prior stroke, tumor or trauma sequelae, cognitively challenged, behavioral disorder, etc.) or intra-op history, but currently unable to assess because of sedation], then a post-op MODS score was set to missing and a 28-day ΔMODS was not computed. The total MODS score ranges from 0 (best possible) to 24 points (worst possible).

  3. Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)

    Time frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first

  4. Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)

    Time frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first

  5. Composite of Major Pulmonary Events (Any Mechanical Ventilation From 48 Hours Post-operation to Day 7, Hospital Discharge or Death, Whichever Comes First, or Pulmonary Embolism)

    Time frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first

  6. Ventilation Duration

    Time frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first

    Because some subjects may experience multiple periods of ventilator use, the total duration that they were on a ventilator was compared between the two groups.

  7. Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value

    Time frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first

  8. Change in Troponin-I From Pre-operative Value to Worst Post-operative Value

    Time frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first

  9. Change in Lactate From Pre-operative Value to Worst Post-operative Value

    Time frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first

    The arterial lactate levels were adjusted to make them comparable to venous lactate levels.

  10. Change in Bilirubin From Pre-operative Value to Worst Post-operative Value

    Time frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first

  11. Change in ALT From Pre-operative Value to Worst Post-operative Value (for Pediatric Subjects Only)

    Time frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first

  12. Days to First Bowel Movement

    Time frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first

    Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analyses are from randomization to first post-operative bowel movement.

  13. Days to First Solid Food

    Time frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first

    Subjects were randomized for RECESS no earlier than one calendar day before the planned date of surgery, and were followed until post-operative Day 28, death, or study withdrawal, whichever occurred first. In some cases the surgery was postponed after randomization had already occurred. If surgery did not occur within 30 days after randomization, the subject ended the study and was not considered evaluable. If surgery did occur within 30 days after randomization, and the subject received at least one RBC transfusion between randomization and 96 hours after the end of surgery, the subject was considered evaluable. Therefore, in a few evaluable subjects, post-operative Day 28 could be nearly two months after the date of randomization. The times in the time-to-event analyses are from randomization to first post-operative solid food.

  14. Days Alive and Ventilator Free Through Post-op Day 28

    Time frame: Through post-op day 28

  15. Any Mechanical Ventilation More Than 48 Hours Post-operation

    Time frame: 48 hours post-operation through day 28, hospital discharge, or death, whichever occurs first

Sponsors and collaborators

Lead sponsor

Carelon Research

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: RECESS

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 8, 2009
Registry last updated
Jun 9, 2015

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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