Red Cell Storage Duration Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00991341

Acronym

RECESS

Enrollment

1481

Registered

2009-10-08

Start date

2010-01-31

Completion date

2014-03-31

Last updated

2015-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Erythrocyte Transfusion

Keywords

Cardiac surgery, Red blood cell, Transfusion

Brief 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. 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.

Interventions

BIOLOGICALRed blood cell units stored <= 10 days

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.

BIOLOGICALRed blood cell units stored >= 21 days

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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.	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).

Secondary

Measure	Time frame	Description
All-cause Mortality	28 days post-surgery	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.
Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.	Through 28 days post-surgery, hospital discharge, or death, whichever occurs first	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).
Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)	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)	Through post-operative day 7, hospital discharge, or death, whichever occurs first	—
Ventilation Duration	Through post-operative day 28, hospital discharge, or death, whichever occurs first	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.
Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value	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	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)	Through post-operative day 7, hospital discharge, or death, whichever occurs first	—
Change in Bilirubin From Pre-operative Value to Worst Post-operative Value	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)	Through post-operative day 7, hospital discharge, or death, whichever occurs first	—
Days to First Bowel Movement	Through post-operative day 28, hospital discharge, or death, whichever occurs first	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.
Days to First Solid Food	Through post-operative day 28, hospital discharge, or death, whichever occurs first	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.
Days Alive and Ventilator Free Through Post-op Day 28	Through post-op day 28	—
Any Mechanical Ventilation More Than 48 Hours Post-operation	48 hours post-operation through day 28, hospital discharge, or death, whichever occurs first	—
Change in Lactate From Pre-operative Value to Worst Post-operative Value	Through post-operative day 7, hospital discharge, or death, whichever occurs first	The arterial lactate levels were adjusted to make them comparable to venous lactate levels.

Countries

United States

Participant flow

Recruitment details

RECESS recruitment took place at 33 US hospitals, beginning in January 2010 and ending in January 2014.

Pre-assignment details

Randomization was stratified by age (≥18 yrs or \<18 yrs) and by whether or not the subject was in the ICU prior to surgery. A subject could not be randomized unless prior to surgery but no earlier than one calendar day prior to surgery, the transfusion service had enough suitable units of both storage durations to satisfy the cross-match request.

Participants by arm

Arm	Count
Shorter-storage Red Blood Cell Units Red blood cell units stored \<= 10 days Red blood cell units stored \<= 10 days: 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.	538
Longer-storage Red Blood Cell Units Red blood cell units stored \>= 21 days Red blood cell units stored \>= 21 days: 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.	560
Total	1,098

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Death	3	0
Overall Study	no RBCs received 96hrs after randomized	186	155
Overall Study	no surgery w/in 30 days of randomization	11	18
Overall Study	Physician Decision	1	2
Overall Study	Withdrawal by Subject	3	4

Baseline characteristics

Characteristic	Total	Longer-storage Red Blood Cell Units	Shorter-storage Red Blood Cell Units
ABO Blood Group A	481 participants	241 participants	240 participants
ABO Blood Group AB	46 participants	21 participants	25 participants
ABO Blood Group B	127 participants	63 participants	64 participants
ABO Blood Group O	444 participants	235 participants	209 participants
Age, Continuous	72 years	72 years	73 years
Age, Customized <18 years	4 participants	2 participants	2 participants
Age, Customized >= 18 years	1094 participants	558 participants	536 participants
Baseline Multiple Organ Dysfunction Score 0	545 participants	293 participants	252 participants
Baseline Multiple Organ Dysfunction Score 1	417 participants	194 participants	223 participants
Baseline Multiple Organ Dysfunction Score 2	105 participants	57 participants	48 participants
Baseline Multiple Organ Dysfunction Score 3	21 participants	11 participants	10 participants
Baseline Multiple Organ Dysfunction Score 4	8 participants	4 participants	4 participants
Baseline Multiple Organ Dysfunction Score 5	2 participants	1 participants	1 participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants	19 Participants	13 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1019 Participants	513 Participants	506 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	47 Participants	28 Participants	19 Participants
Height	165 cm	165 cm	165 cm
Hemoglobin	11.9 g/L	12.0 g/L	11.7 g/L
ICU Status at Randomization In ICU Before Surgery	67 participants	33 participants	34 participants
ICU Status at Randomization Not in ICU Before Surgery	1031 participants	527 participants	504 participants
Minimum TRUST Score 0	1 participants	0 participants	1 participants
Minimum TRUST Score 3	388 participants	222 participants	166 participants
Minimum TRUST Score 4	406 participants	196 participants	210 participants
Minimum TRUST Score 5	245 participants	113 participants	132 participants
Minimum TRUST Score 6	53 participants	27 participants	26 participants
Minimum TRUST Score 7	5 participants	2 participants	3 participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants	1 Participants	1 Participants
Race (NIH/OMB) Asian	19 Participants	8 Participants	11 Participants
Race (NIH/OMB) Black or African American	71 Participants	39 Participants	32 Participants
Race (NIH/OMB) More than one race	5 Participants	3 Participants	2 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants	1 Participants	3 Participants
Race (NIH/OMB) Unknown or Not Reported	19 Participants	15 Participants	4 Participants
Race (NIH/OMB) White	978 Participants	493 Participants	485 Participants
Region of Enrollment United States	1098 participants	560 participants	538 participants
Sex: Female, Male Female	623 Participants	313 Participants	310 Participants
Sex: Female, Male Male	475 Participants	247 Participants	228 Participants
Weight	75 kg	74 kg	75 kg

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	324 / 538	334 / 560
serious Total, serious adverse events	283 / 538	288 / 560

Outcome results

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.

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).

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

Population: Analysis is restricted to evaluable subjects (defined as randomized subjects who underwent cardiac surgery within 30 days after randomization and received at least one RBC transfusion between randomization and post-operative hour 96).

Arm	Measure	Value (MEAN)	Dispersion
Shorter-storage Red Blood Cell Units	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 MOD score points	Standard Deviation 3.62
Longer-storage Red Blood Cell Units	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.	8.66 MOD score points	Standard Deviation 3.55

p-value: 0.4495% CI: [-0.6, 0.26]ANCOVA

Secondary

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.

Time frame: 28 days post-surgery

Arm	Measure	Value (NUMBER)
Shorter-storage Red Blood Cell Units	All-cause Mortality	23 participants with event
Longer-storage Red Blood Cell Units	All-cause Mortality	29 participants with event

p-value: 0.595% CI: [0.48, 1.43]Regression, Cox

Secondary

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

Arm	Measure	Value (NUMBER)
Shorter-storage Red Blood Cell Units	Any Mechanical Ventilation More Than 48 Hours Post-operation	68 participants with event
Longer-storage Red Blood Cell Units	Any Mechanical Ventilation More Than 48 Hours Post-operation	80 participants with event

p-value: 0.5395% CI: [-0.057, 0.027]Fisher Exact

Secondary

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

Population: Only 4 pediatric subjects were enrolled. One treatment arm had only one subject with available data for analyzing the change in ALT. Therefore, to protect patient confidentiality, results were not entered.

Secondary

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

Arm	Measure	Value (MEAN)	Dispersion
Shorter-storage Red Blood Cell Units	Change in Bilirubin From Pre-operative Value to Worst Post-operative Value	0.85 mg/dL	Standard Deviation 1.24
Longer-storage Red Blood Cell Units	Change in Bilirubin From Pre-operative Value to Worst Post-operative Value	1.49 mg/dL	Standard Deviation 2.53

p-value: <0.0195% CI: [-0.89, -0.41]ANCOVA

Secondary

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.

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

Arm	Measure	Value (MEAN)	Dispersion
Shorter-storage Red Blood Cell Units	Change in Lactate From Pre-operative Value to Worst Post-operative Value	2.30 mmol/L	Standard Deviation 3.33
Longer-storage Red Blood Cell Units	Change in Lactate From Pre-operative Value to Worst Post-operative Value	2.92 mmol/L	Standard Deviation 5.97

p-value: 0.1Kruskal-Wallis

Secondary

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).

Time frame: Through 28 days post-surgery, hospital discharge, or death, whichever occurs first

Arm	Measure	Value (MEAN)	Dispersion
Shorter-storage Red Blood Cell Units	Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.	8.74 MOD score points	Standard Deviation 4.04
Longer-storage Red Blood Cell Units	Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.	9.07 MOD score points	Standard Deviation 4.22

p-value: 0.295% CI: [-0.82, 0.17]ANCOVA

Secondary

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

Arm	Measure	Value (MEAN)	Dispersion
Shorter-storage Red Blood Cell Units	Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value	0.35 mg/dL	Standard Deviation 0.58
Longer-storage Red Blood Cell Units	Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value	0.35 mg/dL	Standard Deviation 0.51

p-value: 0.6295% CI: [-0.08, 0.05]ANCOVA

Secondary

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

Arm	Measure	Value (MEAN)	Dispersion
Shorter-storage Red Blood Cell Units	Change in Troponin-I From Pre-operative Value to Worst Post-operative Value	15.82 ng/mL	Standard Deviation 37.64
Longer-storage Red Blood Cell Units	Change in Troponin-I From Pre-operative Value to Worst Post-operative Value	14.06 ng/mL	Standard Deviation 23.77

Comparison: Troponin-I values recorded as 'too low to detect' were recoded as 0 since the median value of the minimum quantitative troponin-I value obtained among all participating sites was 0.01.p-value: 0.3595% CI: [-2.11, 5.98]ANCOVA

Secondary

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

Arm	Measure	Value (NUMBER)
Shorter-storage Red Blood Cell Units	Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)	206 participants with event
Longer-storage Red Blood Cell Units	Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)	230 participants with event

p-value: 0.495% CI: [-0.09, 0.035]Fisher Exact

Secondary

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

Arm	Measure	Value (NUMBER)
Shorter-storage Red Blood Cell Units	Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)	91 participants with event
Longer-storage Red Blood Cell Units	Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)	87 participants with event

p-value: 0.595% CI: [-0.033, 0.069]Fisher Exact

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)

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

Arm	Measure	Value (NUMBER)
Shorter-storage Red Blood Cell Units	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 participants with event
Longer-storage Red Blood Cell Units	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)	75 participants with event

p-value: 0.4195% CI: [-0.059, 0.023]Fisher Exact

Secondary

Days Alive and Ventilator Free Through Post-op Day 28

Time frame: Through post-op day 28

Arm	Measure	Value (MEAN)	Dispersion
Shorter-storage Red Blood Cell Units	Days Alive and Ventilator Free Through Post-op Day 28	25.38 days	Standard Deviation 6.4
Longer-storage Red Blood Cell Units	Days Alive and Ventilator Free Through Post-op Day 28	25.17 days	Standard Deviation 6.75

p-value: 0.7195% CI: [-0.59, 1]Kruskal-Wallis

Secondary

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.

Time frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first

Arm	Measure	Value (MEAN)	Dispersion
Shorter-storage Red Blood Cell Units	Days to First Bowel Movement	5.89 days	Standard Error 0.17
Longer-storage Red Blood Cell Units	Days to First Bowel Movement	6.62 days	Standard Error 0.25

p-value: 0.1195% CI: [0.98, 1.25]Regression, Cox

Secondary

Days to First Solid Food

Time frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first

Arm	Measure	Value (MEAN)	Dispersion
Shorter-storage Red Blood Cell Units	Days to First Solid Food	5.73 days	Standard Error 0.37
Longer-storage Red Blood Cell Units	Days to First Solid Food	6.18 days	Standard Error 0.35

p-value: 0.2295% CI: [0.96, 1.22]Regression, Cox

Secondary

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.

Time frame: Through post-operative day 28, hospital discharge, or death, whichever occurs first

Arm	Measure	Value (MEAN)	Dispersion
Shorter-storage Red Blood Cell Units	Ventilation Duration	2.7 days	Standard Deviation 3.9
Longer-storage Red Blood Cell Units	Ventilation Duration	2.8 days	Standard Deviation 4.3

p-value: 0.7595% CI: [-0.62, 0.37]Kruskal-Wallis

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026

Red Cell Storage Duration Study

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

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.

All-cause Mortality

Any Mechanical Ventilation More Than 48 Hours Post-operation

Change in ALT From Pre-operative Value to Worst Post-operative Value (for Pediatric Subjects Only)

Change in Bilirubin From Pre-operative Value to Worst Post-operative Value

Change in Lactate From Pre-operative Value to Worst Post-operative Value

Change in Multiple Organ Dysfunction Score From Pre-operative Baseline.

Change in Serum Creatinine From Pre-operative Value to Worst Post-operative Value

Change in Troponin-I From Pre-operative Value to Worst Post-operative Value

Composite of Major Cardiac Events (Death, Myocardial Infarction, Low Cardiac Output, Ventricular Tachycardia, Ventricular Fibrillation)

Composite of Major In-hospital Post-operative Complications (Death, Stroke, Myocardial Infarction, Renal Failure, Culture-proven Sepsis/Septic Shock)

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)

Days Alive and Ventilator Free Through Post-op Day 28

Days to First Bowel Movement

Days to First Solid Food

Ventilation Duration