Trial Outcomes & Findings for Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients With Cardiovascular Disease (NCT NCT00071032)

NCT ID: NCT00071032

Last Updated: 2020-11-16

Results Overview

ascertained via telephone follow-up

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 2016 participants
• Primary outcome timeframe: 60 days after randomization
• Results posted on: 2020-11-16

Participant Flow

Participant milestones

Measure	Liberal (10 g/dL) Transfusion Strategy Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Overall Study STARTED	1007	1009
Overall Study COMPLETED	998	1001
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Measure	Liberal (10 g/dL) Transfusion Strategy Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Overall Study Lost to Follow-up	1	1
Overall Study Withdrawal by Subject	8	6
Overall Study Missing Primary Outcome	0	1

Baseline Characteristics

Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients With Cardiovascular Disease

Baseline characteristics by cohort

Measure	Liberal (10 g/dL) Transfusion Strategy n=1007 Participants Transfusion strategy that maintains postoperative Hgb levels above 10 g/dL. Liberal (10 g/dL) Transfusion Strategy: Maintains postoperative Hgb levels above 10 g/dL. This threshold strategy uses enough red blood cell units to maintain Hgb levels at or above 10 g/dL through hospital discharge or up to 30 days after randomization.	Restrictive Strategy n=1009 Participants Symptomatic transfusion strategy, a more conservative strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia. Restrictive (Symptomatic) Transfusion Strategy: Transfusion is withheld until the patient develops symptoms from anemia (i.e., chest pain or ECG changes thought to be ischemic, congestive heart failure, unexplained tachycardia or hypotension unresponsive to fluids) or until the hemoglobin level falls below 8 g/dL. Transfusion is permitted, but is not mandatory, if the hemoglobin level falls below 8 g/dL.	Total n=2016 Participants Total of all reporting groups
Age, Continuous	81.8 years STANDARD_DEVIATION 8.8 • n=5 Participants	81.5 years STANDARD_DEVIATION 9.0 • n=7 Participants	81.6 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	757 Participants n=5 Participants	770 Participants n=7 Participants	1527 Participants n=5 Participants
Sex: Female, Male Male	250 Participants n=5 Participants	239 Participants n=7 Participants	489 Participants n=5 Participants
Region of Enrollment United States	609 participants n=5 Participants	613 participants n=7 Participants	1222 participants n=5 Participants
Region of Enrollment Canada	398 participants n=5 Participants	396 participants n=7 Participants	794 participants n=5 Participants
Cardiovascular Disease History of Cardiovascular Disease	637 participants n=5 Participants	631 participants n=7 Participants	1268 participants n=5 Participants
Cardiovascular Disease No History of Cardiovascular Disease	370 participants n=5 Participants	378 participants n=7 Participants	748 participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days after randomization

ascertained via telephone follow-up

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=998 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=1001 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death	351 participants	347 participants

SECONDARY outcome

Timeframe: In-hospital

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=1005 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=1008 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Myocardial Infarction, Unstable Angina, or Death for Any Reason	43 participants	52 participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=995 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=1000 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Mortality at 30 Days	52 Participants	43 Participants

SECONDARY outcome

Timeframe: 60 Days

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=998 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=1001 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Mortality at 60 Days	76 Participants	66 Participants

SECONDARY outcome

Timeframe: In-hospital

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=1005 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=1007 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Composite Outcomes (a) Death, Myocardial Infarction, or Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism, or Stroke Death, myocardial infarction, or pneumonia	89 Participants	90 Participants
Composite Outcomes (a) Death, Myocardial Infarction, or Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism, or Stroke Death, MI, pnuemonia, thromboembolism or stroke	103 Participants	94 Participants

SECONDARY outcome

Timeframe: In-hospital

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=1005 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=1008 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Myocardial Infarction	23 Participants	38 Participants

SECONDARY outcome

Timeframe: In hospital

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=1005 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=1007 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Postoperative Complications (e.g., Wound Infection, Thromboembolism, Stroke) Wound Infection	14 Participants	8 Participants
Postoperative Complications (e.g., Wound Infection, Thromboembolism, Stroke) Thromboembolism	12 Participants	8 Participants
Postoperative Complications (e.g., Wound Infection, Thromboembolism, Stroke) Stroke	8 Participants	3 Participants

SECONDARY outcome

Timeframe: 60 days

Nursing Home Residence

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=996 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=1001 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Disposition Status (i.e., Nursing Home Placement)	137 Participants	161 Participants

SECONDARY outcome

Timeframe: 30 days

Using the Functional Status Index, score range 0 to 11, higher scores indicate greater dependency

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=472 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=507 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Function - Lower Extremity Activities of Daily Living,at 30 Days	7.3 score on a scale Standard Deviation 4.0	7.4 score on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: 30 days

Using the Older Americans Resources and Services Functional Assessment Questionnaire, score range from 0 to 4, higher scores indicating greater dependency

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=437 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=450 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Function - Instrumental Activities of Daily Living, at 30 Days	3.9 score on a scale Standard Deviation 0.5	3.9 score on a scale Standard Deviation 0.4

SECONDARY outcome

Timeframe: 30 days

Using the Functional Assessment of Chronic Illnesses Therapy-Fatigue, score range from 0 to 52, higher scores indicating greater level of energy

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=456 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=459 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Function - Fatigue/Energy, at 30 Days	38.7 score on a scale Standard Deviation 7.7	38.6 score on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: 60 Days

Scale range 0 to 11, higher scores indicate greater dependency

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=523 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=553 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Function - Lower Extremity Activities of Daily Living. at 60 Days	5.1 score on a scale Standard Deviation 4.2	5.1 score on a scale Standard Deviation 4.3

SECONDARY outcome

Timeframe: 60 Days

Scale range 0 to 11, higher scores indicate greater dependency

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=389 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=411 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Function - Instrumental Activities of Daily Living, at 60 Days	3.7 score on a scale Standard Deviation 0.8	3.7 score on a scale Standard Deviation 0.9

SECONDARY outcome

Timeframe: 60 Days

Scale ranging from 0 to 52, higher scores indicating greater level of energy

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=544 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=525 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Function - Fatigue/Energy, at 60 Days	41.8 score on a scale Standard Deviation 7.3	42.3 score on a scale Standard Deviation 7.4

SECONDARY outcome

Timeframe: Days from randomization to discharge

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=608 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=612 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Length of Stay in Hospital for United States Participants	3.67 days Standard Deviation 3.38	3.97 days Standard Deviation 3.89

SECONDARY outcome

Timeframe: Days from randomization to discharge

Outcome measures

Measure	Liberal (10 g/dL) Transfusion Strategy n=397 Participants Transfusion strategy that maintains postoperative Hgb levels \>= 10 g/dL	Restrictive Strategy n=394 Participants Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Length of Stay in Hospital for Canadian Participants	12.03 days Standard Deviation 9.31	12.70 days Standard Deviation 9.48

Adverse Events

Liberal (10 g/dL) Transfusion Strategy

Serious events: 76 serious events

Other events: 0 other events

Deaths: 0 deaths

Restrictive Strategy

Serious events: 66 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Liberal (10 g/dL) Transfusion Strategy n=1007 participants at risk Transfusion strategy that maintains post randomization Hgb levels \>= 10 g/dL	Restrictive Strategy n=1009 participants at risk Symptomatic transfusion strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
General disorders Death at 60 days	7.6% 76/998 • Number of events 76 • Up to 60 days following randomization Medical events were captured during hospitalization (up to 30 days); mortality was determined at 60 days. There were a total of 2016 Number of Participants at Risk (1007 in the "Liberal Strategy" and 1009 in the "Restrictive Strategy" Arms/Groups), however, the number at risk was not the same for all events due to some missing data.	6.6% 66/1001 • Number of events 66 • Up to 60 days following randomization Medical events were captured during hospitalization (up to 30 days); mortality was determined at 60 days. There were a total of 2016 Number of Participants at Risk (1007 in the "Liberal Strategy" and 1009 in the "Restrictive Strategy" Arms/Groups), however, the number at risk was not the same for all events due to some missing data.
Cardiac disorders Myocardial Infarction	2.3% 23/1005 • Number of events 23 • Up to 60 days following randomization Medical events were captured during hospitalization (up to 30 days); mortality was determined at 60 days. There were a total of 2016 Number of Participants at Risk (1007 in the "Liberal Strategy" and 1009 in the "Restrictive Strategy" Arms/Groups), however, the number at risk was not the same for all events due to some missing data.	3.8% 38/1008 • Up to 60 days following randomization Medical events were captured during hospitalization (up to 30 days); mortality was determined at 60 days. There were a total of 2016 Number of Participants at Risk (1007 in the "Liberal Strategy" and 1009 in the "Restrictive Strategy" Arms/Groups), however, the number at risk was not the same for all events due to some missing data.
Cardiac disorders Unstable Angina	0.20% 2/1005 • Number of events 2 • Up to 60 days following randomization Medical events were captured during hospitalization (up to 30 days); mortality was determined at 60 days. There were a total of 2016 Number of Participants at Risk (1007 in the "Liberal Strategy" and 1009 in the "Restrictive Strategy" Arms/Groups), however, the number at risk was not the same for all events due to some missing data.	0.30% 3/1008 • Number of events 3 • Up to 60 days following randomization Medical events were captured during hospitalization (up to 30 days); mortality was determined at 60 days. There were a total of 2016 Number of Participants at Risk (1007 in the "Liberal Strategy" and 1009 in the "Restrictive Strategy" Arms/Groups), however, the number at risk was not the same for all events due to some missing data.
Cardiac disorders Congestive Heart Failure	2.7% 27/1005 • Number of events 27 • Up to 60 days following randomization Medical events were captured during hospitalization (up to 30 days); mortality was determined at 60 days. There were a total of 2016 Number of Participants at Risk (1007 in the "Liberal Strategy" and 1009 in the "Restrictive Strategy" Arms/Groups), however, the number at risk was not the same for all events due to some missing data.	3.5% 35/1007 • Number of events 35 • Up to 60 days following randomization Medical events were captured during hospitalization (up to 30 days); mortality was determined at 60 days. There were a total of 2016 Number of Participants at Risk (1007 in the "Liberal Strategy" and 1009 in the "Restrictive Strategy" Arms/Groups), however, the number at risk was not the same for all events due to some missing data.
Vascular disorders Stroke	0.80% 8/1005 • Number of events 8 • Up to 60 days following randomization Medical events were captured during hospitalization (up to 30 days); mortality was determined at 60 days. There were a total of 2016 Number of Participants at Risk (1007 in the "Liberal Strategy" and 1009 in the "Restrictive Strategy" Arms/Groups), however, the number at risk was not the same for all events due to some missing data.	0.30% 3/1007 • Number of events 3 • Up to 60 days following randomization Medical events were captured during hospitalization (up to 30 days); mortality was determined at 60 days. There were a total of 2016 Number of Participants at Risk (1007 in the "Liberal Strategy" and 1009 in the "Restrictive Strategy" Arms/Groups), however, the number at risk was not the same for all events due to some missing data.

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey L Carson, MD

Rutgers Robert Wood Johnsom 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