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Red Cell Storage Duration Study

Phase 3
12 Years
Open (Enrolling)
Cardiac Surgery, Erythrocyte Transfusion

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Trial Information

Red Cell Storage Duration Study

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Time Frame:

Through post-operative day 7, hospital discharge, or death, whichever occurs first

Safety Issue:


Principal Investigator

Susan F Assmann, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New England Research Institutes


United States: Federal Government

Study ID:




Start Date:

January 2010

Completion Date:

October 2013

Related Keywords:

  • Cardiac Surgery
  • Erythrocyte Transfusion
  • Cardiac surgery
  • Red blood cell
  • Transfusion



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