Trial Outcomes & Findings for Myocardial Ischemia and Transfusion (NCT NCT02981407)

NCT ID: NCT02981407

Last Updated: 2024-05-09

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 3506 participants
• Primary outcome timeframe: Within 30 days of randomization
• Results posted on: 2024-05-09

Participant Flow

Participant milestones

Measure	Liberal Transfusion Strategy Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Red Blood Cell Transfusion: Transfusion of packed red blood cell units	Restrictive Transfusion Strategy Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. Red Blood Cell Transfusion: Transfusion of packed red blood cell units
Overall Study STARTED	1757	1749
Overall Study Data at 30 Days Post Randomization	1755	1749
Overall Study COMPLETED	1755	1749
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Liberal Transfusion Strategy Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Red Blood Cell Transfusion: Transfusion of packed red blood cell units	Restrictive Transfusion Strategy Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. Red Blood Cell Transfusion: Transfusion of packed red blood cell units
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Myocardial Ischemia and Transfusion

Baseline characteristics by cohort

Measure	Liberal Transfusion Strategy n=1755 Participants Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Red Blood Cell Transfusion: Transfusion of packed red blood cell units	Restrictive Transfusion Strategy n=1749 Participants Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. Red Blood Cell Transfusion: Transfusion of packed red blood cell units	Total n=3504 Participants Total of all reporting groups
Age, Continuous	72.1 years STANDARD_DEVIATION 11.6 • n=5 Participants	72.2 years STANDARD_DEVIATION 11.5 • n=7 Participants	72.1 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	819 Participants n=5 Participants	774 Participants n=7 Participants	1593 Participants n=5 Participants
Sex: Female, Male Male	936 Participants n=5 Participants	975 Participants n=7 Participants	1911 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	134 Participants n=5 Participants	119 Participants n=7 Participants	253 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1434 Participants n=5 Participants	1445 Participants n=7 Participants	2879 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	187 Participants n=5 Participants	185 Participants n=7 Participants	372 Participants n=5 Participants
Race/Ethnicity, Customized White	1245 Participants n=5 Participants	1229 Participants n=7 Participants	2474 Participants n=5 Participants
Race/Ethnicity, Customized Black	223 Participants n=5 Participants	217 Participants n=7 Participants	440 Participants n=5 Participants
Race/Ethnicity, Customized Other	115 Participants n=5 Participants	129 Participants n=7 Participants	244 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	172 Participants n=5 Participants	174 Participants n=7 Participants	346 Participants n=5 Participants
Type of Myocardial Infarction Type 1	730 Participants n=5 Participants	730 Participants n=7 Participants	1460 Participants n=5 Participants
Type of Myocardial Infarction Type 2	988 Participants n=5 Participants	967 Participants n=7 Participants	1955 Participants n=5 Participants
Type of Myocardial Infarction Other or Unknown	37 Participants n=5 Participants	52 Participants n=7 Participants	89 Participants n=5 Participants
ST or Non-ST-Elevation Myocardial Infarction STEMI	337 Participants n=5 Participants	319 Participants n=7 Participants	656 Participants n=5 Participants
ST or Non-ST-Elevation Myocardial Infarction NSTEMI	1418 Participants n=5 Participants	1430 Participants n=7 Participants	2848 Participants n=5 Participants
History of Myocardial Infarction Yes	549 Participants n=5 Participants	589 Participants n=7 Participants	1138 Participants n=5 Participants
History of Myocardial Infarction No	1206 Participants n=5 Participants	1160 Participants n=7 Participants	2366 Participants n=5 Participants
History of Percuatneous Coronary Intervention Yes	577 Participants n=5 Participants	623 Participants n=7 Participants	1200 Participants n=5 Participants
History of Percuatneous Coronary Intervention No	1177 Participants n=5 Participants	1126 Participants n=7 Participants	2303 Participants n=5 Participants
History of Percuatneous Coronary Intervention Unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
History of Coronary Artery Bypass Surgery Yes	390 Participants n=5 Participants	372 Participants n=7 Participants	762 Participants n=5 Participants
History of Coronary Artery Bypass Surgery No	1365 Participants n=5 Participants	1377 Participants n=7 Participants	2742 Participants n=5 Participants
History of Heart Failure Yes	539 Participants n=5 Participants	527 Participants n=7 Participants	1066 Participants n=5 Participants
History of Heart Failure No	1216 Participants n=5 Participants	1222 Participants n=7 Participants	2438 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 30 days of randomization

Outcome measures

Measure	Liberal Transfusion Strategy n=1755 Participants Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Red Blood Cell Transfusion: Transfusion of packed red blood cell units	Restrictive Transfusion Strategy n=1749 Participants Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. Red Blood Cell Transfusion: Transfusion of packed red blood cell units
Number of Participants With All-cause Mortality or Nonfatal Myocardial Reinfarction	255 Participants	295 Participants

SECONDARY outcome

Timeframe: Within 30 days of randomization

Outcome measures

Measure	Liberal Transfusion Strategy n=1755 Participants Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Red Blood Cell Transfusion: Transfusion of packed red blood cell units	Restrictive Transfusion Strategy n=1749 Participants Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. Red Blood Cell Transfusion: Transfusion of packed red blood cell units
All-cause Mortality	146 Participants	173 Participants

SECONDARY outcome

Timeframe: Within 30 days of randomization

Outcome measures

Measure	Liberal Transfusion Strategy n=1755 Participants Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Red Blood Cell Transfusion: Transfusion of packed red blood cell units	Restrictive Transfusion Strategy n=1749 Participants Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. Red Blood Cell Transfusion: Transfusion of packed red blood cell units
Myocardial Reinfarction	126 Participants	149 Participants

SECONDARY outcome

Timeframe: Within 30 days of randomization

Outcome measures

Measure	Liberal Transfusion Strategy n=1755 Participants Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Red Blood Cell Transfusion: Transfusion of packed red blood cell units	Restrictive Transfusion Strategy n=1749 Participants Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. Red Blood Cell Transfusion: Transfusion of packed red blood cell units
Composite of All-cause Mortality, Nonfatal Myocardial Reinfarction, Ischemia Driven Unscheduled Coronary Revascularization, or Readmission to the Hospital for Ischemic Cardiac Diagnosis	305 Participants	342 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days of randomization

Outcome measures

Measure	Liberal Transfusion Strategy n=1755 Participants Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Red Blood Cell Transfusion: Transfusion of packed red blood cell units	Restrictive Transfusion Strategy n=1749 Participants Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. Red Blood Cell Transfusion: Transfusion of packed red blood cell units
Composite of All-cause Mortality,Nonfatal Myocardial Reinfarction, or Unstable Angina	300 Participants	338 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days of randomization

Outcome measures

Measure	Liberal Transfusion Strategy n=1755 Participants Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Red Blood Cell Transfusion: Transfusion of packed red blood cell units	Restrictive Transfusion Strategy n=1749 Participants Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. Red Blood Cell Transfusion: Transfusion of packed red blood cell units
Ischemia Driven Unscheduled Coronary Revascularization	39 Participants	43 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days of randomization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days of randomization

Outcome measures

Measure	Liberal Transfusion Strategy n=1755 Participants Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Red Blood Cell Transfusion: Transfusion of packed red blood cell units	Restrictive Transfusion Strategy n=1749 Participants Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. Red Blood Cell Transfusion: Transfusion of packed red blood cell units
Heart Failure	111 Participants	102 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days of randomization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days of randomization

Outcome measures

Measure	Liberal Transfusion Strategy n=1755 Participants Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Red Blood Cell Transfusion: Transfusion of packed red blood cell units	Restrictive Transfusion Strategy n=1749 Participants Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. Red Blood Cell Transfusion: Transfusion of packed red blood cell units
Stroke	26 Participants	30 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days of randomization

Outcome measures

Measure	Liberal Transfusion Strategy n=1755 Participants Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Red Blood Cell Transfusion: Transfusion of packed red blood cell units	Restrictive Transfusion Strategy n=1749 Participants Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. Red Blood Cell Transfusion: Transfusion of packed red blood cell units
Pulmonary Embolism or Deep Venous Thrombosis	34 Participants	26 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days of randomization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days of randomization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days of randomization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days of randomization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days of randomization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days of randomization

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 30 days of randomization

EuroQol questionnaire

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 6 months of randomization

Outcome measures

Outcome data not reported

Adverse Events

Liberal Transfusion Strategy

Serious events: 699 serious events

Other events: 330 other events

Deaths: 353 deaths

Restrictive Transfusion Strategy

Serious events: 723 serious events

Other events: 348 other events

Deaths: 376 deaths

Serious adverse events

Measure	Liberal Transfusion Strategy n=1755 participants at risk Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Red Blood Cell Transfusion: Transfusion of packed red blood cell units	Restrictive Transfusion Strategy n=1749 participants at risk Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. Red Blood Cell Transfusion: Transfusion of packed red blood cell units
Cardiac disorders Myocardial Infarction	7.2% 126/1755 • Number of events 126 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	8.5% 149/1749 • Number of events 149 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Cardiac disorders Heart Failure	6.3% 111/1755 • Number of events 111 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	5.8% 102/1749 • Number of events 102 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Cardiac disorders Super ventricular tachycardia	1.6% 28/1755 • Number of events 28 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	1.5% 27/1749 • Number of events 27 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Cardiac disorders Ventricular tachycardia	3.2% 56/1755 • Number of events 56 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	3.4% 59/1749 • Number of events 59 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Cardiac disorders Ventricular fibrillation	0.80% 14/1755 • Number of events 14 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	1.1% 19/1749 • Number of events 19 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Cardiac disorders Cardiac arrest	2.6% 45/1755 • Number of events 45 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	3.9% 69/1749 • Number of events 69 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Cardiac disorders Mobitz type 2 atrial ventricular block	0.74% 13/1755 • Number of events 13 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	0.86% 15/1749 • Number of events 15 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Cardiac disorders Complete atrial ventricular block	0.80% 14/1755 • Number of events 14 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	0.74% 13/1749 • Number of events 13 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Cardiac disorders Asystole	1.9% 33/1755 • Number of events 33 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	2.3% 41/1749 • Number of events 41 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Cardiac disorders Transfusion associated cardiac overload	1.3% 23/1755 • Number of events 23 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	0.46% 8/1749 • Number of events 8 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Nervous system disorders Stroke	1.5% 26/1755 • Number of events 26 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	1.7% 30/1749 • Number of events 30 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Nervous system disorders Transient ischemic attack	0.17% 3/1755 • Number of events 3 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	0.29% 5/1749 • Number of events 5 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Vascular disorders Pulmonary embolism or deep venous thrombosis	1.9% 34/1755 • Number of events 34 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	1.5% 26/1749 • Number of events 26 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Blood and lymphatic system disorders Acute hemolytic transfusion reaction	0.11% 2/1755 • Number of events 2 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	0.00% 0/1749 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Blood and lymphatic system disorders Anaphylactic transfusion reaction	0.11% 2/1755 • Number of events 2 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	0.11% 2/1749 • Number of events 2 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Infections and infestations Pneumonia or Bacteremai	8.7% 153/1755 • Number of events 153 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	9.5% 166/1749 • Number of events 166 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Infections and infestations Transfusion associated sepsis	0.06% 1/1755 • Number of events 1 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	0.00% 0/1749 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	8.7% 153/1755 • Number of events 153 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	8.5% 148/1749 • Number of events 148 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Renal and urinary disorders Acute renal failure	13.3% 233/1755 • Number of events 233 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	13.3% 233/1749 • Number of events 233 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Respiratory, thoracic and mediastinal disorders Transfusion related acute lung injury	0.34% 6/1755 • Number of events 6 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	0.00% 0/1749 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status

Other adverse events

Measure	Liberal Transfusion Strategy n=1755 participants at risk Red blood cell transfusion - One unit of packed red cells is transfused following randomization followed by enough red blood cell units to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Red Blood Cell Transfusion: Transfusion of packed red blood cell units	Restrictive Transfusion Strategy n=1749 participants at risk Permitted to receive a red blood cell transfusion if the blood count is below 8 g/dL and the physician believes it is in the patient's best interest. A transfusion will be strongly recommended if the blood count drops to less than 7 g/dL. If the patient has symptoms of angina (e.g., chest discomfort described as pressure or heaviness) that do not go away with medication, a blood transfusion will be ordered regardless of the blood count. Red Blood Cell Transfusion: Transfusion of packed red blood cell units
Cardiac disorders Atrial Fibrillation	10.7% 187/1755 • Number of events 187 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	11.1% 194/1749 • Number of events 194 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status
Cardiac disorders Stable Angina	10.4% 183/1755 • Number of events 183 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status	10.1% 176/1749 • Number of events 186 • Adverse event data were collected through 30 days and death was collected through 180 days Research staff contacted participants/proxies at 30 days to collect clinical events and at 180 days to determine vital status

Additional Information

Dr. Jeffrey Carson

Rutgers Robert Wood Johnson Medical School

Phone: 732-235-7122

Email: jeffrey.carson@rutgers.edu

Results disclosure agreements

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