Cardiac SurgeryPhase 3RECESSNCT00991341
Red Cell Storage Duration Study
A Phase 3 study testing Red blood cell units stored <= 10 days and Red blood cell units stored >= 21 days in people with Cardiac Surgery and Erythrocyte Transfusion, run by Carelon Research at 33 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cardiac Surgery, Erythrocyte Transfusion
- What is being tested?
- Red blood cell units stored <= 10 days and Red blood cell units stored >= 21 days
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,481 participants
- Where
- 33 sitesUnited States
- Study dates
- Jan 2010to Mar 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- >= 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Emory University
Atlanta, Georgia, 30322
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins University
Baltimore, Maryland, 21287
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Children's Hospital Boston
Boston, Massachusetts, 02115
Massachusetts General Hospital
Boston, Massachusetts, 02115
St. Elizabeth's Medical Center
Boston, Massachusetts, 02116
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
UT Southwestern
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27713
Sanford Heart Center
Fargo, North Dakota, 58122
St. Joseph Hospital
Fort Wayne, Indiana, 46802
Indiana/Ohio Heart
Fort Wayne, Indiana, 46804
University of Florida
Gainesville, Florida, 32610
Texas Heart Institute
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53201
Aurora St. Lukes Medical Center
Milwaukee, Wisconsin, 53215
Fairview Southdale Hospital/University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37323
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Columbia University Health Center
New York, New York, 10032
Weill Cornell Medical School
New York, New York, 10065
Newark Beth Israel Deaconess Medical Center
Newark, New Jersey, 07112
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of Pittsburgh Presbyterian and Shadyside
Pittsburgh, Pennsylvania, 15213
UPMC-Mercy Hospital
Pittsburgh, Pennsylvania, 15219
Mayo Clinic
Rochester, Minnesota, 55905
Veterans Administration Puget Sound
Seattle, Washington, 98108
Swedish Medical Center
Seattle, Washington, 98195
Baystate Medical Center
Springfield, Massachusetts, 01199
Aspirus Vascular Heart Center
Wausau, Wisconsin, 54401
About this 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.
- Conditions
- Cardiac Surgery, Erythrocyte Transfusion
- Being tested
- Red blood cell units stored <= 10 days, Red blood cell units stored >= 21 days
- Keywords
- Cardiac surgery, Red blood cell, Transfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Red blood cell units stored <= 10 daysBiological
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 daysBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Shorter-storage red blood cell units | Active comparator | Red blood cell units stored <= 10 days Receives: Biological: Red blood cell units stored <= 10 days |
| Longer-storage red blood cell units | Active comparator | Red blood cell units stored >= 21 days Receives: Biological: Red blood cell units stored >= 21 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through post-operative day 7, hospital discharge, or death, whichever occurs first
Secondary outcomes (15)
All-cause Mortality
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.
Measured: 28 days post-surgery
Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.
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).
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Through post-operative day 7, hospital discharge, or death, whichever occurs first
Ventilation Duration
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.
Measured: Through post-operative day 28, hospital discharge, or death, whichever occurs first
Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value
Measured: Through post-operative day 7, hospital discharge, or death, whichever occurs first
Change in Troponin-I From Pre-operative Value to Worst Post-operative Value
Measured: Through post-operative day 7, hospital discharge, or death, whichever occurs first
Change in Lactate From Pre-operative Value to Worst Post-operative Value
The arterial lactate levels were adjusted to make them comparable to venous lactate levels.
Measured: Through post-operative day 7, hospital discharge, or death, whichever occurs first
Change in Bilirubin From Pre-operative Value to Worst Post-operative Value
Measured: Through post-operative day 7, hospital discharge, or death, whichever occurs first
Change in ALT From Pre-operative Value to Worst Post-operative Value (for Pediatric Subjects Only)
Measured: Through post-operative day 7, hospital discharge, or death, whichever occurs first
Days to First Bowel Movement
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.
Measured: Through post-operative day 28, hospital discharge, or death, whichever occurs first
Days to First Solid Food
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.
Measured: Through post-operative day 28, hospital discharge, or death, whichever occurs first
Days Alive and Ventilator Free Through Post-op Day 28
Measured: Through post-op day 28
Any Mechanical Ventilation More Than 48 Hours Post-operation
Measured: 48 hours post-operation through day 28, hospital discharge, or death, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2009 (estimated)
- Study startJan 2010
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,481 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carelon Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Susan F Assmann, PhD, Principal investigator, Carelon ResearchSteven Sloan, MD, Principal investigator, Boston Children's HospitalThomas Ortel, MD, Principal investigator, Duke UniversityCassandra Josephson, MD, Principal investigator, Emory UniversityChristopher Stowell, MD, Principal investigator, Massachusetts General HospitalMeghan Delaney, DO, Principal investigator, University of Washington/Fred Hutchinson Cancer Research CenterMarie Steiner, MD, Principal investigator, University of Minnesota Medical Center FairviewDarrell Triulzi, MD, Principal investigator, University of Pittsburgh Presbyterian and Shadyside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00991341
- Sponsor's protocol ID
- 676
- Other IDs
- U01HL072268, HL072268, HL072033, HL072291, HL072196, HL072289, HL072248, HL072191
- Acronym
- RECESS
- Status last verified
- May 2014
- First submitted
- 7 Oct 2009
- Last updated
- 9 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 28333704Steiner 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.
PubMed 25853746Kekre 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.
PubMed 23874777Berra 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.
PubMed 22531338Steiner 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.
PubMed 20655807
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Cell Storage Duration Study
- ClinicalTrials.gov ID
- NCT00991341
- Acronym / sponsor ID
- RECESS / 676
- Conditions
- Cardiac Surgery, Erythrocyte Transfusion
- Keywords
- Cardiac surgery, Red blood cell, Transfusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,481 participants (actual)
- Lead sponsor
- Carelon ResearchUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 8 Oct 2009 (estimated)
- Results
- Posted 9 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shorter-storage red blood cell units | Active comparator | Biological: Red blood cell units stored <= 10 daysRed blood cell units stored <= 10 days |
| Longer-storage red blood cell units | Active comparator | Biological: Red blood cell units stored >= 21 daysRed blood cell units stored >= 21 days |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- >= 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Red blood cell units stored <= 10 daysPre-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. | Biological | Shorter-storage red blood cell units |
| Red blood cell units stored >= 21 daysPre-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. | Biological | Longer-storage red blood cell units |
Primary outcome
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).
15 secondary outcomes
All-cause Mortality
Time frame: 28 days post-surgery
Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first
Ventilation Duration
Time frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first
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
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
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
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
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
Days to First Bowel Movement
Time frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first
Days to First Solid Food
Time frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first
Days Alive and Ventilator Free Through Post-op Day 28
Time frame: Through post-op day 28
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28333704Delaney 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.
- Derived from this study: PubMed 25853746Steiner 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.
- Derived from this study: PubMed 23874777Kekre 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.
- Derived from this study: PubMed 22531338Berra 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.
- Derived from this study: PubMed 20655807Steiner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan F Assmann, PhD principal investigator
Carelon Research
Steven Sloan, MD principal investigator
Boston Children's Hospital
Thomas Ortel, MD principal investigator
Duke University
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Red blood cell units stored <= 10 days and Red blood cell units stored >= 21 days in people with Cardiac Surgery and Erythrocyte Transfusion, run by Carelon Research at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Through post-operative day 7, hospital discharge, or death, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00991341, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2015; AzTrials last refreshed its copy on 26 Oct 2026.