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Red Cell Storage Duration Study

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Trial Conditions
  • Cardiac Surgery
  • Erythrocyte Transfusion
What is the purpose of this trial?

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.

Date & Status

Recruiting

Who can Participate?

Eligibility

Ages:
12 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Susan F Assmann, PhD
  • Steven Sloan, MD
  • Thomas Ortel, MD
  • Cassandra Josephson, MD
  • Christopher Stowell, MD
  • Meghan Delaney, DO
  • Marie Steiner, MD
  • Darrell Triulzi, MD
  • Lynne Uhl, MD
  • Richard Kaufman, MD
  • James Bussel, MD
  • Paul Ness, MD
  • Thomas Raife, MD
  • Rhonda Cooke, MD
  • Nigel Key, MD
  • Jeff Carson, MD
  • Vincent Scavo, MD
  • Wade Fischer, MD, FACS
  • Pampee Young, MD
  • Kathy Puca, MD
  • James George, MD
  • Gregory Nuttall, MD
  • Arthur Bracey, MD
  • Richard Engleman, MD
  • Philip Greileich, MD
  • Kent Berg, MD
  • Robert Hunsaker, MD
  • Ronald Miles, MD
  • Ravindra Karanam, MD
  • Cornelius Dyke, MD
  • Eldad Hod, MD
Trial Interventions
Biological
  • Red blood cell units stored <= 10 days
  • Red blood cell units stored >= 21 days
Physician Researcher

Investigator Name:

  • Susan F Assmann, PhD
  • Steven Sloan, MD
  • Thomas Ortel, MD
  • Cassandra Josephson, MD
  • Christopher Stowell, MD
  • Meghan Delaney, DO
  • Marie Steiner, MD
  • Darrell Triulzi, MD
  • Lynne Uhl, MD
  • Richard Kaufman, MD
  • James Bussel, MD
  • Paul Ness, MD
  • Thomas Raife, MD
  • Rhonda Cooke, MD
  • Nigel Key, MD
  • Jeff Carson, MD
  • Vincent Scavo, MD
  • Wade Fischer, MD, FACS
  • Pampee Young, MD
  • Kathy Puca, MD
  • James George, MD
  • Gregory Nuttall, MD
  • Arthur Bracey, MD
  • Richard Engleman, MD
  • Philip Greileich, MD
  • Kent Berg, MD
  • Robert Hunsaker, MD
  • Ronald Miles, MD
  • Ravindra Karanam, MD
  • Cornelius Dyke, MD
  • Eldad Hod, MD

Other Information

Sponsor: New England Research Institutes
Phase: Phase 3
Trial ID: NCT00991341
Volunteers:  Not Accepting Healthy Volunteers

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