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

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ClinicalTrials.gov Identifier: NCT00071032
Recruitment Status : Completed
First Posted : October 13, 2003
Results First Posted : August 28, 2014
Last Update Posted : August 28, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
rwjmsmedicine, Rutgers, The State University of New Jersey

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (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
Enrollment 2016
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Liberal (10 g/dL) Transfusion Strategy Restrictive Strategy
Hide Arm/Group Description Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
Period Title: Overall Study
Started 1007 1009
Completed 998 1001
Not Completed 9 8
Reason Not Completed
Lost to Follow-up             1             1
Withdrawal by Subject             8             6
Missing Primary Outcome             0             1
Arm/Group Title Liberal (10 g/dL) Transfusion Strategy Restrictive Strategy Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 1007 1009 2016
Hide Baseline Analysis Population Description
Randomized subjects
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1007 participants 1009 participants 2016 participants
81.8  (8.8) 81.5  (9.0) 81.6  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1007 participants 1009 participants 2016 participants
Female
757
  75.2%
770
  76.3%
1527
  75.7%
Male
250
  24.8%
239
  23.7%
489
  24.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1007 participants 1009 participants 2016 participants
United States 609 613 1222
Canada 398 396 794
Cardiovascular Disease   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 1007 participants 1009 participants 2016 participants
History of Cardiovascular Disease 637 631 1268
No History of Cardiovascular Disease 370 378 748
[1]
Measure Description: History of coronary artery disease, congestive heart failure, cardiovascular disease, or peripheral vascular disease
1.Primary Outcome
Title Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death
Hide Description ascertained via telephone follow-up
Time Frame 60 days after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberal (10 g/dL) Transfusion Strategy Restrictive Strategy
Hide Arm/Group Description:
Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
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 Number of Participants Analyzed 998 1001
Measure Type: Number
Unit of Measure: participants
351 347
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liberal (10 g/dL) Transfusion Strategy, Restrictive Strategy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.01
Confidence Interval (2-Sided) 95%
0.84 to 1.22
Estimation Comments Liberal Arm (numerator) compared to Restrictive Arm (denominator)
2.Secondary Outcome
Title Myocardial Infarction, Unstable Angina, or Death for Any Reason
Hide Description [Not Specified]
Time Frame In-hospital
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liberal (10 g/dL) Transfusion Strategy Restrictive Strategy
Hide Arm/Group Description:
Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
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
Overall Number of Participants Analyzed 1005 1008
Measure Type: Number
Unit of Measure: participants
43 52
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liberal (10 g/dL) Transfusion Strategy, Restrictive Strategy
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.9
Confidence Interval (2-Sided) 99%
-3.3 to 1.6
Estimation Comments Liberal Arm (numerator) compared to Restrictive Arm (denominator)
3.Secondary Outcome
Title Postoperative Complications (e.g., Pneumonia, Wound Infection, Thromboembolism, Stroke)
Hide Description [Not Specified]
Time Frame In hospital
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Survival
Hide Description [Not Specified]
Time Frame 30-daym, 60- day and long term up to 5 years
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Disposition Status (i.e., Nursing Home Placement)
Hide Description [Not Specified]
Time Frame 60 days
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Function (e.g., Lower Extremity Activities of Daily Living, Instrumental Activities of Daily Living, Fatigue/Energy)
Hide Description [Not Specified]
Time Frame 30 and 60 days
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Length of Stay in Hospital
Hide Description [Not Specified]
Time Frame In-hospital
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Myocardial Infarction
Hide Description [Not Specified]
Time Frame In-hospital
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Composite Outcomes (a) Death, Myocardial Infarction, and Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism and Stroke)
Hide Description [Not Specified]
Time Frame In-hospital
Outcome Measure Data Not Reported
Time Frame Up to 60 days following randomization
Adverse Event Reporting Description medical events were captured during hospitalization (up to 30 days); mortality was determined at 60 days
 
Arm/Group Title Liberal (10 g/dL) Transfusion Strategy Restrictive Strategy
Hide Arm/Group Description Transfusion strategy that maintains post randomization Hgb levels >= 10 g/dL 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
All-Cause Mortality
Liberal (10 g/dL) Transfusion Strategy Restrictive Strategy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Liberal (10 g/dL) Transfusion Strategy Restrictive Strategy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   76/1007 (7.55%)      66/1009 (6.54%)    
Cardiac disorders     
Myocardial Infarction  [1]  23/1005 (2.29%)  23 38/1008 (3.77%) 
Unstable Angina  [1]  2/1005 (0.20%)  2 3/1008 (0.30%)  3
Congestive Heart Failure  [1]  27/1005 (2.69%)  27 35/1007 (3.48%)  35
General disorders     
Death at 60 days  [2]  76/998 (7.62%)  76 66/1001 (6.59%)  66
Vascular disorders     
Stroke  [1]  8/1005 (0.80%)  8 3/1007 (0.30%)  3
Indicates events were collected by systematic assessment
[1]
during hospitalization (up to 30 days)
[2]
Detected via telephone follow-up
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Liberal (10 g/dL) Transfusion Strategy Restrictive Strategy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/1007 (0.00%)      0/1009 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jeffrey L Carson, MD
Organization: Rutgers Robert Wood Johnsom Medical School
Phone: 732-235-7122
EMail: Jeffrey.Carson@rutgers.edu
Layout table for additonal information
Responsible Party: rwjmsmedicine, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00071032     History of Changes
Other Study ID Numbers: 159
U01HL073958-06 ( U.S. NIH Grant/Contract )
U01HL073958 ( U.S. NIH Grant/Contract )
U01HL074815 ( U.S. NIH Grant/Contract )
First Submitted: October 9, 2003
First Posted: October 13, 2003
Results First Submitted: August 14, 2014
Results First Posted: August 28, 2014
Last Update Posted: August 28, 2014