NCT00991341|CompletedPhase 3ResultsDMC
Red Cell Storage Duration Study
RECESS
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Sponsor study identifier
Secondary identifiers
NIH
interventional
1,481
1 country
33
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2014
Actual (reported)Study Completion
March 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 7, 2009
Actual (reported)October 8, 2009
Actual (reported)January 2010
Date type not reportedThis date has not been verified as actual or estimated.
March 2014
Actual (reported)March 2014
Actual (reported)June 9, 2015
Actual (reported)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.
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).
Through post-operative day 7, hospital discharge, or death, whichever occurs first
All-cause Mortality
28 days post-surgery
Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.
Through 28 days post-surgery, hospital discharge, or death, whichever occurs first
Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)
Through post-operative day 7, hospital discharge, or death, whichever occurs first
Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)
Through post-operative day 7, hospital discharge, or death, whichever occurs first
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)
Through post-operative day 7, hospital discharge, or death, whichever occurs first
Red blood cell units stored \<= 10 days
Red blood cell units stored \>= 21 days
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.
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.
University of Florida
Gainesville, Florida, 32610, United States
Emory University
Atlanta, Georgia, 30322, United States
St. Joseph Hospital
Fort Wayne, Indiana, 46802, United States
Indiana/Ohio Heart
Fort Wayne, Indiana, 46804, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
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.
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.
Only 4 pediatric subjects were enrolled. One treatment arm had only one subject with available data for analyzing the change in ALT outcome. Therefore, to protect patient confidentiality, results were not entered for this outcome.
Susan F Assmann, PhD
Carelon Research
Steven Sloan, MD
Boston Children's Hospital
Thomas Ortel, MD
Duke University
Cassandra Josephson, MD
Emory University
1,481 participants (actual enrollment reported by the registry).
First Submitted
October 7, 2009
First Posted
October 8, 2009
Study Start
January 2010
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy and Safety of Sodium Heparin (Hipolabor) in Patients
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Children's Hospital Boston
Boston, Massachusetts, 02115, United States
Massachusetts General Hospital
Boston, Massachusetts, 02115, United States
St. Elizabeth's Medical Center
Boston, Massachusetts, 02116, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Baystate Medical Center
Springfield, Massachusetts, 01199, United States
Fairview Southdale Hospital/University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903, United States
Newark Beth Israel Deaconess Medical Center
Newark, New Jersey, 07112, United States
Columbia University Health Center
New York, New York, 10032, United States
Weill Cornell Medical School
New York, New York, 10065, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Duke University
Durham, North Carolina, 27713, United States
Sanford Heart Center
Fargo, North Dakota, 58122, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
University of Pittsburgh Presbyterian and Shadyside
Pittsburgh, Pennsylvania, 15213, United States
UPMC-Mercy Hospital
Pittsburgh, Pennsylvania, 15219, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37323, United States
UT Southwestern
Dallas, Texas, 75390, United States
Texas Heart Institute
Houston, Texas, 77030, United States
Veterans Administration Puget Sound
Seattle, Washington, 98108, United States
Swedish Medical Center
Seattle, Washington, 98195, United States
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53201, United States
Aurora St. Lukes Medical Center
Milwaukee, Wisconsin, 53215, United States
Aspirus Vascular Heart Center
Wausau, Wisconsin, 54401, United States
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.
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.
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.
Christopher Stowell, MD
Massachusetts General Hospital
Meghan Delaney, DO
University of Washington/Fred Hutchinson Cancer Research Center
Marie Steiner, MD
University of Minnesota Medical Center Fairview
Darrell Triulzi, MD
University of Pittsburgh Presbyterian and Shadyside
Lynne Uhl, MD
Beth Israel Deaconess Medical Center
Richard Kaufman, MD
Brigham and Women's Hospital
James Bussel, MD
Weill Medical College of Cornell University
Paul Ness, MD
Johns Hopkins University
Thomas Raife, MD
University of Iowa
Rhonda Cooke, MD
University of Maryland
Nigel Key, MD
University of North Carolina, Chapel Hill
Jeff Carson, MD
Rutgers, The State University of New Jersey
Vincent Scavo, MD
Indiana/Ohio Heart
Wade Fischer, MD, FACS
Froedtert Hospital
Pampee Young, MD
Vanderbilt University
Kathy Puca, MD
St. Luke's Hospital
James George, MD
University of Oklahoma
Gregory Nuttall, MD
Mayo Clinic
Arthur Bracey, MD
Texas Heart Institute
Richard Engleman, MD
Baystate Medical Center
Philip Greileich, MD
University of Texas
Kent Berg, MD
University of Florida
Robert Hunsaker, MD
St. Elizabeth's Medical Center
Ronald Miles, MD
Aspirus Medical Center
Ravindra Karanam, MD
Barnabas Health, Newark Beth Israel Medical Center
Cornelius Dyke, MD
Sanford Heart Center
Eldad Hod, MD
Columbia University Health Center
Primary Completion
March 2014
Actual (reported)Study Completion
March 2014
Actual (reported)Last Updated
June 9, 2015
Results First Posted
June 9, 2015
Record last verified: 2014-05
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Source: ClinicalTrials.gov.
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