Clinical trial NCT00991341: Red Cell Storage Duration Study
Official title: Red Cell Storage Duration Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cardiac Surgery
Erythrocyte Transfusion
Keywords: Cardiac surgery
Red blood cell
Transfusion
Lead sponsor: Carelon Research
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2009-10-08
Enrollment: 1481
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: Through post-operative day 7, hospital discharge, or death, whichever occurs first
Secondary outcomes:
measure: All-cause Mortality
timeFrame: 28 days post-surgery
measure: Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.
timeFrame: Through 28 days post-surgery, hospital discharge, or death, whichever occurs first
measure: Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)
timeFrame: Through post-operative day 7, hospital discharge, or death, whichever occurs first
measure: Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)
timeFrame: Through post-operative day 7, hospital discharge, or death, whichever occurs first
measure: 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)
timeFrame: Through post-operative day 7, hospital discharge, or death, whichever occurs first
measure: Ventilation Duration
timeFrame: Through post-operative day 28, hospital discharge, or death, whichever occurs first
measure: Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value
timeFrame: Through post-operative day 7, hospital discharge, or death, whichever occurs first
measure: Change in Troponin-I From Pre-operative Value to Worst Post-operative Value
timeFrame: Through post-operative day 7, hospital discharge, or death, whichever occurs first
measure: Change in Lactate From Pre-operative Value to Worst Post-operative Value
timeFrame: Through post-operative day 7, hospital discharge, or death, whichever occurs first
measure: Change in Bilirubin From Pre-operative Value to Worst Post-operative Value
timeFrame: Through post-operative day 7, hospital discharge, or death, whichever occurs first
measure: Change in ALT From Pre-operative Value to Worst Post-operative Value (for Pediatric Subjects Only)
timeFrame: Through post-operative day 7, hospital discharge, or death, whichever occurs first
measure: Days to First Bowel Movement
timeFrame: Through post-operative day 28, hospital discharge, or death, whichever occurs first
measure: Days to First Solid Food
timeFrame: Through post-operative day 28, hospital discharge, or death, whichever occurs first
measure: Days Alive and Ventilator Free Through Post-op Day 28
timeFrame: Through post-op day 28
measure: Any Mechanical Ventilation More Than 48 Hours Post-operation
timeFrame: 48 hours post-operation through day 28, hospital discharge, or death, whichever occurs first
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Fort Wayne
country: United States
facility: St. Joseph Hospital
state: Indiana
city: Fort Wayne
country: United States
facility: Indiana/Ohio Heart
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Fairview Southdale Hospital/University of Minnesota Medical Center Fairview
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New Brunswick
country: United States
facility: Robert Wood Johnson Medical School
state: New Jersey
city: Newark
country: United States
facility: Newark Beth Israel Deaconess Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Health Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical School
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Fargo
country: United States
facility: Sanford Heart Center
state: North Dakota
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Pittsburgh
country: United States
facility: University of Pittsburgh Presbyterian and Shadyside
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC-Mercy Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: Texas Heart Institute
state: Texas
city: Seattle
country: United States
facility: Veterans Administration Puget Sound
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Froedtert Memorial Lutheran Hospital
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora St. Lukes Medical Center
state: Wisconsin
city: Wausau
country: United States
facility: Aspirus Vascular Heart Center
state: Wisconsin
Study officials:
affiliation: Carelon Research
name: Susan F Assmann, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Boston Children's Hospital
name: Steven Sloan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Thomas Ortel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Cassandra Josephson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Christopher Stowell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Washington/Fred Hutchinson Cancer Research Center
name: Meghan Delaney, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota Medical Center Fairview
name: Marie Steiner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Presbyterian and Shadyside
name: Darrell Triulzi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Lynne Uhl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Richard Kaufman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University
name: James Bussel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Paul Ness, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Thomas Raife, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Rhonda Cooke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Nigel Key, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers, The State University of New Jersey
name: Jeff Carson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana/Ohio Heart
name: Vincent Scavo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Froedtert Hospital
name: Wade Fischer, MD, FACS
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Pampee Young, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Hospital
name: Kathy Puca, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oklahoma
name: James George, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Gregory Nuttall, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Heart Institute
name: Arthur Bracey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Baystate Medical Center
name: Richard Engleman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas
name: Philip Greileich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Kent Berg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Elizabeth's Medical Center
name: Robert Hunsaker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Aspirus Medical Center
name: Ronald Miles, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barnabas Health, Newark Beth Israel Medical Center
name: Ravindra Karanam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanford Heart Center
name: Cornelius Dyke, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University Health Center
name: Eldad Hod, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Delaney M, Stark PC, Suh M, Triulzi DJ, Hess JR, Steiner ME, Stowell CP, Sloan SR. Massive Transfusion in Cardiac Surgery: The Impact of Blood Component Ratios on Clinical Outcomes and Survival. Anesth Analg. 2017 Jun;124(6):1777-1782. doi: 10.1213/ANE.0000000000001926.
citation: Steiner ME, Ness PM, Assmann SF, Triulzi DJ, Sloan SR, Delaney M, Granger S, Bennett-Guerrero E, Blajchman MA, Scavo V, Carson JL, Levy JH, Whitman G, D'Andrea P, Pulkrabek S, Ortel TL, Bornikova L, Raife T, Puca KE, Kaufman RM, Nuttall GA, Young PP, Youssef S, Engelman R, Greilich PE, Miles R, Josephson CD, Bracey A, Cooke R, McCullough J, Hunsaker R, Uhl L, McFarland JG, Park Y, Cushing MM, Klodell CT, Karanam R, Roberts PR, Dyke C, Hod EA, Stowell CP. Effects of red-cell storage duration on patients undergoing cardiac surgery. N Engl J Med. 2015 Apr 9;372(15):1419-29. doi: 10.1056/NEJMoa1414219.
citation: Kekre N, Mallick R, Allan D, Tinmouth A, Tay J. The impact of prolonged storage of red blood cells on cancer survival. PLoS One. 2013 Jul 16;8(7):e68820. doi: 10.1371/journal.pone.0068820. Print 2013.
citation: Berra L, Coppadoro A, Yu B, Lei C, Spagnolli E, Steinbicker AU, Bloch KD, Lin T, Sammy FY, Warren HS, Fernandez BO, Feelisch M, Dzik WH, Stowell CP, Zapol WM. Transfusion of stored autologous blood does not alter reactive hyperemia index in healthy volunteers. Anesthesiology. 2012 Jul;117(1):56-63. doi: 10.1097/ALN.0b013e31825575e6.
citation: Steiner ME, Assmann SF, Levy JH, Marshall J, Pulkrabek S, Sloan SR, Triulzi D, Stowell CP. Addressing the question of the effect of RBC storage on clinical outcomes: the Red Cell Storage Duration Study (RECESS) (Section 7). Transfus Apher Sci. 2010 Aug;43(1):107-16. doi: 10.1016/j.transci.2010.05.014. Epub 2010 Jul 23.