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Red Cell Storage Duration Study


Phase 3
12 Years
N/A
Open (Enrolling)
Both
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:

Interventional

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:

No

Principal Investigator

Susan F Assmann, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

New England Research Institutes

Authority:

United States: Federal Government

Study ID:

676

NCT ID:

NCT00991341

Start Date:

January 2010

Completion Date:

October 2013

Related Keywords:

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

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
University of IowaIowa City, Iowa  52242
Mayo ClinicRochester, Minnesota  55905
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Baystate Medical CenterSpringfield, Massachusetts  01199
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Robert Wood Johnson Medical SchoolNew Brunswick, New Jersey  08903
Massachusetts General HospitalBoston, Massachusetts  02114-2617
St. Elizabeth's Medical CenterBoston, Massachusetts  02135-2997
Froedtert Memorial Lutheran HospitalMilwaukee, Wisconsin  53226
Duke UniversityDurham, North Carolina  27710
Children's Hospital BostonBoston, Massachusetts  02115
Swedish Medical CenterSeattle, Washington  98122-4307
Emory UniversityAtlanta, Georgia  30322
University of MarylandBaltimore, Maryland  21201
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Brigham & Women's HospitalBoston, Massachusetts  02115
UT SouthwesternDallas, Texas  75390
Tulane UniversityNew Orleans, Louisiana  70112-2699
University of Pittsburgh Presbyterian and ShadysidePittsburgh, Pennsylvania  15213
Indiana/Ohio HeartFort Wayne, Indiana  46804
St. Joseph HospitalFort Wayne, Indiana  46802
Fairview Southdale Hospital/University of Minnesota Medical Center FairviewMinneapolis, Minnesota  55455
Weill Cornell Medical SchoolNew York, New York  10065
UPMC-Mercy HospitalPittsburgh, Pennsylvania  15219
Texas Heart InstituteHouston, Texas  77030
Veterans Administration Puget SoundSeattle, Washington  98108
Aurora St. Lukes Medical CenterMilwaukee, Wisconsin  53215