Red Cell Storage Duration Study

NCT00991341 | Completed Phase 3 Results DMC

• 20 other identifiers: 676U01HL072268HL072268HL072033HL072291HL072196HL072289HL072248HL072191HL072299HL072305HL072274HL072028HL072359HL072072HL072355HL072283HL072346HL072331HL072290
• Study Type: interventional
• Target: 1,481
• Locations: 1 country
• Sites: 33

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.

Conditions

Cardiac Surgery; Erythrocyte Transfusion

Keywords

Cardiac surgery; Red blood cell; Transfusion

Outcome Measures

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.

  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

Secondary Outcomes (15)

• 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

Study Arms (2)

Shorter-storage red blood cell units

ACTIVE COMPARATOR

Red blood cell units stored \<= 10 days

Biological: Red blood cell units stored <= 10 days

Longer-storage red blood cell units

ACTIVE COMPARATOR

Red blood cell units stored \>= 21 days

Biological: Red blood cell units stored >= 21 days

Interventions

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.

Shorter-storage red blood cell units

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.

Longer-storage red blood cell units

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \>= 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carelon Research: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (33)

University of Florida

Gainesville, Florida, 32610, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

St. Joseph Hospital

Fort Wayne, Indiana, 46802, United States

Location

Indiana/Ohio Heart

Fort Wayne, Indiana, 46804, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

St. Elizabeth's Medical Center

Boston, Massachusetts, 02116, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Fairview Southdale Hospital/University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Newark Beth Israel Deaconess Medical Center

Newark, New Jersey, 07112, United States

Location

Columbia University Health Center

New York, New York, 10032, United States

Location

Weill Cornell Medical School

New York, New York, 10065, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27713, United States

Location

Sanford Heart Center

Fargo, North Dakota, 58122, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pittsburgh Presbyterian and Shadyside

Pittsburgh, Pennsylvania, 15213, United States

Location

UPMC-Mercy Hospital

Pittsburgh, Pennsylvania, 15219, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37323, United States

Location

UT Southwestern

Dallas, Texas, 75390, United States

Location

Texas Heart Institute

Houston, Texas, 77030, United States

Location

Veterans Administration Puget Sound

Seattle, Washington, 98108, United States

Location

Swedish Medical Center

Seattle, Washington, 98195, United States

Location

Froedtert Memorial Lutheran Hospital

Milwaukee, Wisconsin, 53201, United States

Location

Aurora St. Lukes Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Aspirus Vascular Heart Center

Wausau, Wisconsin, 54401, United States

Location

Related Publications (5)

• 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.

  PMID: 28333704 DERIVED

• 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.

  PMID: 25853746 DERIVED

• 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.

  PMID: 23874777 DERIVED

• 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.

  PMID: 22531338 DERIVED

• 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.

  PMID: 20655807 DERIVED

Limitations and Caveats

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.

Results Point of Contact

• Title: Susan Assmann, PhD
• Organization: New England Research Institutes

sassmann@neriscience.com

617-972-3048

Study Officials

• Susan F Assmann, PhD

  Carelon Research

  PRINCIPAL INVESTIGATOR

• Steven Sloan, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

• Thomas Ortel, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Cassandra Josephson, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Christopher Stowell, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Meghan Delaney, DO

  University of Washington/Fred Hutchinson Cancer Research Center

  PRINCIPAL INVESTIGATOR

• Marie Steiner, MD

  University of Minnesota Medical Center Fairview

  PRINCIPAL INVESTIGATOR

• Darrell Triulzi, MD

  University of Pittsburgh Presbyterian and Shadyside

  PRINCIPAL INVESTIGATOR

• Lynne Uhl, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• Richard Kaufman, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• James Bussel, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Paul Ness, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Thomas Raife, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

• Rhonda Cooke, MD

  University of Maryland

  PRINCIPAL INVESTIGATOR

• Nigel Key, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Jeff Carson, MD

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

• Vincent Scavo, MD

  Indiana/Ohio Heart

  PRINCIPAL INVESTIGATOR

• Wade Fischer, MD, FACS

  Froedtert Hospital

  PRINCIPAL INVESTIGATOR

• Pampee Young, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

• Kathy Puca, MD

  St. Luke's Hospital

  PRINCIPAL INVESTIGATOR

• James George, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

• Gregory Nuttall, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Arthur Bracey, MD

  Texas Heart Institute

  PRINCIPAL INVESTIGATOR

• Richard Engleman, MD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

• Philip Greileich, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

• Kent Berg, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

• Robert Hunsaker, MD

  St. Elizabeth's Medical Center

  PRINCIPAL INVESTIGATOR

• Ronald Miles, MD

  Aspirus Medical Center

  PRINCIPAL INVESTIGATOR

• Ravindra Karanam, MD

  Barnabas Health, Newark Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

• Cornelius Dyke, MD

  Sanford Heart Center

  PRINCIPAL INVESTIGATOR

• Eldad Hod, MD

  Columbia University Health Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2009
• First Posted: October 8, 2009
• Study Start: January 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: June 9, 2015
• Results First Posted: June 9, 2015

Record last verified: 2014-05

Locations

US (33)