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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
rwjmsmedicine, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00071032
First received: October 9, 2003
Last updated: August 14, 2014
Last verified: August 2014
Results First Received: August 14, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Anemia
Hematologic Diseases
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Thromboembolism
Pneumonia
Cerebrovascular Accident
Interventions: Biological: Liberal (10 g/dL) Transfusion Strategy
Biological: Restrictive (Symptomatic) Transfusion Strategy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Liberal (10 g/dL) Transfusion Strategy     Restrictive Strategy  
STARTED     1007     1009  
COMPLETED     998     1001  
NOT COMPLETED     9     8  
Lost to Follow-up                 1                 1  
Withdrawal by Subject                 8                 6  
Missing Primary Outcome                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Randomized subjects

Reporting Groups
  Description
Liberal (10 g/dL) Transfusion Strategy

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

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 Total of all reporting groups

Baseline Measures
    Liberal (10 g/dL) Transfusion Strategy     Restrictive Strategy     Total  
Number of Participants  
[units: participants]
  1007     1009     2016  
Age  
[units: years]
Mean ± Standard Deviation
  81.8  ± 8.8     81.5  ± 9.0     81.6  ± 8.9  
Gender  
[units: participants]
     
Female     757     770     1527  
Male     250     239     489  
Region of Enrollment  
[units: participants]
     
United States     609     613     1222  
Canada     398     396     794  
Cardiovascular Disease [1]
[units: participants]
     
History of Cardiovascular Disease     637     631     1268  
No History of Cardiovascular Disease     370     378     748  
[1] History of coronary artery disease, congestive heart failure, cardiovascular disease, or peripheral vascular disease



  Outcome Measures
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1.  Primary:   Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death   [ Time Frame: 60 days after randomization ]

2.  Secondary:   Myocardial Infarction, Unstable Angina, or Death for Any Reason   [ Time Frame: In-hospital ]

3.  Secondary:   Postoperative Complications (e.g., Pneumonia, Wound Infection, Thromboembolism, Stroke)   [ Time Frame: In hospital ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Survival   [ Time Frame: 30-daym, 60- day and long term up to 5 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Disposition Status (i.e., Nursing Home Placement)   [ Time Frame: 60 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Function (e.g., Lower Extremity Activities of Daily Living, Instrumental Activities of Daily Living, Fatigue/Energy)   [ Time Frame: 30 and 60 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Length of Stay in Hospital   [ Time Frame: In-hospital ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Myocardial Infarction   [ Time Frame: In-hospital ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Composite Outcomes (a) Death, Myocardial Infarction, and Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism and Stroke)   [ Time Frame: In-hospital ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jeffrey L Carson, MD
Organization: Rutgers Robert Wood Johnsom Medical School
phone: 732-235-7122
e-mail: Jeffrey.Carson@rutgers.edu


Publications of Results:
Other Publications:

Responsible Party: rwjmsmedicine, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00071032     History of Changes
Other Study ID Numbers: 159, U01HL073958-06, U01HL073958, U01HL074815
Study First Received: October 9, 2003
Results First Received: August 14, 2014
Last Updated: August 14, 2014
Health Authority: United States: Federal Government