Trial Outcomes & Findings for Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial (NCT NCT01638416)

NCT ID: NCT01638416

Last Updated: 2020-10-22

Results Overview

Mortality at Day 90

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 4994 participants
• Primary outcome timeframe: 90 Day
• Results posted on: 2020-10-22

Participant Flow

Participant milestones

Measure	Arm B (Short Term Storage) Blood Transfusion Freshest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.	Standard of Care (Long-term Storage) Blood Transfusion Standard of care- oldest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.
Overall Study STARTED	2490	2504
Overall Study COMPLETED	2457	2462
Overall Study NOT COMPLETED	33	42

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Arm B (Short Term Storage) n=2457 Participants Blood Transfusion Freshest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.	Standard of Care (Long Term Storage) n=2462 Participants Blood Transfusion Standard of care- oldest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.	Total n=4919 Participants Total of all reporting groups
Age, Continuous	62.5 years STANDARD_DEVIATION 16.8 • n=2457 Participants	61.4 years STANDARD_DEVIATION 17.3 • n=2462 Participants	62.0 years STANDARD_DEVIATION 17.1 • n=4919 Participants
Sex: Female, Male Female	1146 Participants n=2457 Participants	1204 Participants n=2462 Participants	2350 Participants n=4919 Participants
Sex: Female, Male Male	1311 Participants n=2457 Participants	1258 Participants n=2462 Participants	2569 Participants n=4919 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Primary Diagnosis Cardiovascular Condition	326 Participants n=2457 Participants	342 Participants n=2462 Participants	668 Participants n=4919 Participants
Primary Diagnosis Gastrointestinal Condition	551 Participants n=2457 Participants	514 Participants n=2462 Participants	1065 Participants n=4919 Participants
Primary Diagnosis Respiratory Condition	413 Participants n=2457 Participants	422 Participants n=2462 Participants	835 Participants n=4919 Participants
Primary Diagnosis Sepsis	413 Participants n=2457 Participants	396 Participants n=2462 Participants	809 Participants n=4919 Participants
Primary Diagnosis Trauma	240 Participants n=2457 Participants	262 Participants n=2462 Participants	502 Participants n=4919 Participants
Primary Diagnosis Neurological Condition	177 Participants n=2457 Participants	195 Participants n=2462 Participants	372 Participants n=4919 Participants
Primary Diagnosis Metabolic Condition	68 Participants n=2457 Participants	71 Participants n=2462 Participants	139 Participants n=4919 Participants
Primary Diagnosis Musculoskeletal	103 Participants n=2457 Participants	110 Participants n=2462 Participants	213 Participants n=4919 Participants
Primary Diagnosis Renal Condition	110 Participants n=2457 Participants	109 Participants n=2462 Participants	219 Participants n=4919 Participants
Primary Diagnosis Other Condition	51 Participants n=2457 Participants	35 Participants n=2462 Participants	86 Participants n=4919 Participants
Primary Diagnosis Missing Condition	5 Participants n=2457 Participants	6 Participants n=2462 Participants	11 Participants n=4919 Participants
APACHE III	72.6 units on a scale STANDARD_DEVIATION 29.2 • n=2457 Participants	73.2 units on a scale STANDARD_DEVIATION 29.6 • n=2462 Participants	72.9 units on a scale STANDARD_DEVIATION 29.4 • n=4919 Participants
ABO Blood group Group A	928 Participants n=2457 Participants	961 Participants n=2462 Participants	1889 Participants n=4919 Participants
ABO Blood group Group B	310 Participants n=2457 Participants	303 Participants n=2462 Participants	613 Participants n=4919 Participants
ABO Blood group Group O	1126 Participants n=2457 Participants	1105 Participants n=2462 Participants	2231 Participants n=4919 Participants
ABO Blood group Group AB	92 Participants n=2457 Participants	93 Participants n=2462 Participants	185 Participants n=4919 Participants
ABO Blood group Missing Data	1 Participants n=2457 Participants	0 Participants n=2462 Participants	1 Participants n=4919 Participants
Haemoglobin at Admission to ICU	102 g/liter STANDARD_DEVIATION 23.1 • n=2457 Participants	102 g/liter STANDARD_DEVIATION 23.6 • n=2462 Participants	102 g/liter STANDARD_DEVIATION 23.3 • n=4919 Participants
Haemoglobin at randomisation	77.4 g/liter STANDARD_DEVIATION 12.8 • n=2457 Participants	77.3 g/liter STANDARD_DEVIATION 13.0 • n=2462 Participants	77.3 g/liter STANDARD_DEVIATION 12.9 • n=4919 Participants
SOFA Score	7 units on a scale n=2457 Participants	7 units on a scale n=2462 Participants	7 units on a scale n=4919 Participants

PRIMARY outcome

Timeframe: 90 Day

Population: Pre specified Sub groups

Mortality at Day 90

Outcome measures

Measure	Standard of Care (Long Term Storage) n=2462 Participants Blood Transfusion Standard of care- oldest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.	Arm B (Short Term Storage) n=2457 Participants Blood Transfusion Freshest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.
Mortality at Day 90 All patients	594 participants	610 participants
Mortality at Day 90 Group O	259 participants	264 participants
Mortality at Day 90 Non-Group O	335 participants	346 participants
Mortality at Day 90 APACHE III risk of Death <21.5%	169 participants	152 participants
Mortality at Day 90 APACHE III risk of Death =or>21.5%	425 participants	457 participants
Mortality at Day 90 Baseline SOFA score = or < 7	191 participants	210 participants
Mortality at Day 90 Baseline SOFA score >7	403 participants	400 participants

SECONDARY outcome

Timeframe: 28 day

Mortality at day 28

Outcome measures

Measure	Standard of Care (Long Term Storage) n=2462 Participants Blood Transfusion Standard of care- oldest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.	Arm B (Short Term Storage) n=2457 Participants Blood Transfusion Freshest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.
Mortality at Day 28	463 Participants	476 Participants

SECONDARY outcome

Timeframe: day 28

Persistent Organ Dysfunction combined with death measured at day 28

Outcome measures

Measure	Standard of Care (Long Term Storage) n=2462 Participants Blood Transfusion Standard of care- oldest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.	Arm B (Short Term Storage) n=2457 Participants Blood Transfusion Freshest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.
Persistent Organ Dysfunction Combined With Death Measured at Day 28	549 Participants	573 Participants

SECONDARY outcome

Timeframe: day 28

Days alive and free of mechanical ventilation

Outcome measures

Measure	Standard of Care (Long Term Storage) n=2462 Participants Blood Transfusion Standard of care- oldest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.	Arm B (Short Term Storage) n=2457 Participants Blood Transfusion Freshest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.
Days Alive and Free of Mechanical Ventilation	25 days Interval 13.0 to 28.0	25 days Interval 11.0 to 28.0

SECONDARY outcome

Timeframe: day 28

Day alive and free of renal replacement therapy.

Outcome measures

Measure	Standard of Care (Long Term Storage) n=2462 Participants Blood Transfusion Standard of care- oldest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.	Arm B (Short Term Storage) n=2457 Participants Blood Transfusion Freshest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.
Day Alive and Free of Renal Replacement Therapy.	22 days Interval 22.0 to 28.0	28 days Interval 22.0 to 28.0

SECONDARY outcome

Timeframe: While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4)

Blood stream infection in ICU (post randomisation) Time Frame is in Days

Outcome measures

Measure	Standard of Care (Long Term Storage) n=2462 Participants Blood Transfusion Standard of care- oldest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.	Arm B (Short Term Storage) n=2457 Participants Blood Transfusion Freshest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.
Blood Stream Infection in ICU (Post Randomisation)	88 Participants	123 Participants

SECONDARY outcome

Timeframe: Median duration in ICU- short term storage group 4.2 Days (2.0 - 9.3), long term storage group 4.2 Days (1.9 - 9.4). Median duration in Hospital- short term storage group was 14.5 days (7.4 - 27.5), long term storage group was 14.7 days(7.4 - 28.3)

Median duration in ICU - short term storage group was 4.2 (2.0 - 9.3), long term storage group was 4.2 (1.9 - 9.4) Median duration in Hospital - short term storage group was 14.5 (7.4 - 27.5), long term storage group was 14.7 (7.4 - 28.3) In Days

Outcome measures

Measure	Standard of Care (Long Term Storage) n=2462 Participants Blood Transfusion Standard of care- oldest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.	Arm B (Short Term Storage) n=2457 Participants Blood Transfusion Freshest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.
Length of Stay in ICU and in Hospital Post Randomisation (Days) Days in Hospital	14.7 Days Interval 7.4 to 28.3	14.5 Days Interval 7.4 to 27.5
Length of Stay in ICU and in Hospital Post Randomisation (Days) Days in ICU	4.2 Days Interval 1.9 to 9.4	4.2 Days Interval 2.0 to 9.3

SECONDARY outcome

Timeframe: While in ICU-Median duration in ICU - short term storage group was 4.2 days (2.0 - 9.3), long term storage group was 4.2 days (1.9 - 9.4)

Proportion of patients who suffer at least one febrile non-haemolytic transfusion reaction in ICU

Outcome measures

Measure	Standard of Care (Long Term Storage) n=2462 Participants Blood Transfusion Standard of care- oldest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.	Arm B (Short Term Storage) n=2457 Participants Blood Transfusion Freshest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.
Proportion of Patients Who Suffer at Least One Febrile Non-haemolytic Transfusion Reaction in ICU	39 Participants	35 Participants

SECONDARY outcome

Timeframe: Day 180

EuroQol-5Dimension 5 level (EQ-5D-5L) score at day 180 post randomisation - not reported yet

Outcome measures

Outcome data not reported

Adverse Events

Arm B (Short Term Storage)

Serious events: 0 serious events

Other events: 158 other events

Deaths: 687 deaths

Standard of Care (Long Term Storage)

Serious events: 0 serious events

Other events: 127 other events

Deaths: 678 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Arm B (Short Term Storage) n=2457 participants at risk Blood Transfusion Freshest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.	Standard of Care (Long Term Storage) n=2462 participants at risk Blood Transfusion Standard of care- oldest blood. Blood transfusion: Blood transfusion in ICU patients aged 18 and over.
Immune system disorders Febrile Nonhaemolytic transfusion reaction	1.4% 35/2457 • Primary outcome was all-cause mortality measured up to day 90. Secondary outcomes included mortality / persistent organ dysfunction or death / days alive and free of mechanical ventilation / days alive and free of renal-replacement therapy measured all measured at day 28, new bloodstream infection measured during ICU stay, febrile nonhemolytic transfusion reactions during ICU stay, length of stay (hospital and ICU), and quality of life measured at day 180 after randomization. We defined a febrile nonhemolytic transfusion reaction as occurring when a patient had an unexpected increase in temperature of 1°C or more within 4 hours after transfusion in the absence of other pyretic stimuli.	1.6% 39/2462 • Primary outcome was all-cause mortality measured up to day 90. Secondary outcomes included mortality / persistent organ dysfunction or death / days alive and free of mechanical ventilation / days alive and free of renal-replacement therapy measured all measured at day 28, new bloodstream infection measured during ICU stay, febrile nonhemolytic transfusion reactions during ICU stay, length of stay (hospital and ICU), and quality of life measured at day 180 after randomization. We defined a febrile nonhemolytic transfusion reaction as occurring when a patient had an unexpected increase in temperature of 1°C or more within 4 hours after transfusion in the absence of other pyretic stimuli.
Blood and lymphatic system disorders New Bloodstream Infection in ICU	5.0% 123/2457 • Primary outcome was all-cause mortality measured up to day 90. Secondary outcomes included mortality / persistent organ dysfunction or death / days alive and free of mechanical ventilation / days alive and free of renal-replacement therapy measured all measured at day 28, new bloodstream infection measured during ICU stay, febrile nonhemolytic transfusion reactions during ICU stay, length of stay (hospital and ICU), and quality of life measured at day 180 after randomization. We defined a febrile nonhemolytic transfusion reaction as occurring when a patient had an unexpected increase in temperature of 1°C or more within 4 hours after transfusion in the absence of other pyretic stimuli.	3.6% 88/2462 • Primary outcome was all-cause mortality measured up to day 90. Secondary outcomes included mortality / persistent organ dysfunction or death / days alive and free of mechanical ventilation / days alive and free of renal-replacement therapy measured all measured at day 28, new bloodstream infection measured during ICU stay, febrile nonhemolytic transfusion reactions during ICU stay, length of stay (hospital and ICU), and quality of life measured at day 180 after randomization. We defined a febrile nonhemolytic transfusion reaction as occurring when a patient had an unexpected increase in temperature of 1°C or more within 4 hours after transfusion in the absence of other pyretic stimuli.

Additional Information

Dr. Cooper

Australian and New Zealand Intensive Care Research Centre

Phone: +61 3 9903 0071

Email: anzicrc@monash.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place