Phase 3 N=1,481 Randomized Treatment

Red Cell Storage Duration Study

Cardiac Surgery · Erythrocyte Transfusion

Bottom Line

View on ClinicalTrials.gov: NCT00991341 ↗

Enrolled (actual)

1,481

Serious AEs

52.0%

Results posted

Jun 2015

Primary outcome: Primary: 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. — 8.49; 8.66 MOD score points — p=0.44

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Red blood cell units stored <= 10 days (Biological); Red blood cell units stored >= 21 days (Biological)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: Carelon Research
Primary completion: Mar 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY 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.	8.49; 8.66	0.44
SECONDARY All-cause Mortality	23; 29	0.50
SECONDARY Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.	8.74; 9.07	0.20
SECONDARY Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)	91; 87	0.50
SECONDARY Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)	206; 230	0.40
SECONDARY 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)	62; 75	0.41
SECONDARY Ventilation Duration	2.7; 2.8	0.75
SECONDARY Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value	0.35; 0.35	0.62
SECONDARY Change in Troponin-I From Pre-operative Value to Worst Post-operative Value	15.82; 14.06	0.35
SECONDARY Change in Lactate From Pre-operative Value to Worst Post-operative Value	2.30; 2.92	0.10
SECONDARY Change in Bilirubin From Pre-operative Value to Worst Post-operative Value	0.85; 1.49	<0.01 sig
SECONDARY Change in ALT From Pre-operative Value to Worst Post-operative Value (for Pediatric Subjects Only)	—	—
SECONDARY Days to First Bowel Movement	5.89; 6.62	0.11
SECONDARY Days to First Solid Food	5.73; 6.18	0.22
SECONDARY Days Alive and Ventilator Free Through Post-op Day 28	25.38; 25.17	0.71
SECONDARY Any Mechanical Ventilation More Than 48 Hours Post-operation	68; 80	0.53

Summary

The RECESS study will compare the effects of transfusing 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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00991341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.