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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 9, 2003
First Posted Date  ICMJE October 13, 2003
Results First Submitted Date  ICMJE August 14, 2014
Results First Posted Date  ICMJE August 28, 2014
Last Update Posted Date August 28, 2014
Study Start Date  ICMJE July 2003
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2014)
Inability to Walk 10 Feet or Across a Room Without Human Assistance or Death [ Time Frame: 60 days after randomization ]
ascertained via telephone follow-up
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2011)
  • Myocardial Infarction, Unstable Angina, or Death for Any Reason [ Time Frame: In-hospital ]
  • Postoperative Complications (e.g., Pneumonia, Wound Infection, Thromboembolism, Stroke) [ Time Frame: In hospital ]
  • Survival [ Time Frame: 30-daym, 60- day and long term up to 5 years ]
  • Disposition Status (i.e., Nursing Home Placement) [ Time Frame: 60 days ]
  • Function (e.g., Lower Extremity Activities of Daily Living, Instrumental Activities of Daily Living, Fatigue/Energy) [ Time Frame: 30 and 60 days ]
  • Length of Stay in Hospital [ Time Frame: In-hospital ]
  • Myocardial Infarction [ Time Frame: In-hospital ]
  • Composite Outcomes (a) Death, Myocardial Infarction, and Pneumonia and b) Death, Myocardial Infarction, Pneumonia, Thromboembolism and Stroke) [ Time Frame: In-hospital ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients With Cardiovascular Disease
Official Title  ICMJE Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)
Brief Summary The purpose of this study is to compare liberal red blood cell transfusion therapy with restrictive red blood cell transfusion therapy in surgical patients with cardiovascular disease or risk factors.
Detailed Description

BACKGROUND:

Red blood cell transfusions are an extremely common medical intervention in both the United States and worldwide; over 14 million units of blood are transfused in the United States. Between 60 and 70 percent of all blood is transfused in the surgical setting. Despite the common use of red blood cell transfusions, the threshold for transfusion has not been adequately evaluated and is very controversial. A decade ago, the standard of care was to administer a peri-operative transfusion whenever the hemoglobin (Hgb) level fell below 10 g/dl (the "10/30 rule"). Concerns about the safety of blood, especially with respect to HIV and hepatitis, and the absence of data to support a 10 g/dl threshold led to the current standard of care, which is to administer blood transfusions based on the presence of symptoms, and not a specific Hgb/hematocrit level. However, there have not been any randomized clinical trials done with surgical patients that have tested the efficacy and safety of withholding blood until the patient develops symptoms, or the "10/30" approach to transfusion. Patients with underlying cardiovascular disease are at greatest risk of adverse effects from reduced Hgb levels.

DESIGN NARRATIVE:

This is a multi-center randomized trial to test the effectiveness of a transfusion strategy that maintains postoperative Hgb levels above 10 g/dl (liberal transfusion) in improving patient outcome. This will be compared to the restrictive (symptomatic) transfusion strategy in which blood transfusion is withheld until the patient develops symptoms of anemia or Hgb less than 8 g/dL. Participants will be randomly assigned to one of the two transfusion strategies. The liberal (10 g/dl) threshold strategy will use enough red blood cell units to maintain Hgb levels at or above 10 g/dl through hospital discharge. Restrictive (Symptomatic) transfusion strategy patients will receive red blood cell transfusions for symptoms of anemia, although transfusion is also permitted, but not required, if the Hgb level falls below 8 g/dl. Outcomes will include functional recovery (primary outcome: ability to walk 10 feet across a room without human assistance or death 60 days post-randomization), lower extremity activities of daily living and instrumental activities of daily living, survival up to 60-days and long-term, disposition (i.e., nursing home placement), and postoperative complications (e.g., myocardial infarction, unstable angina, or death in hospital, pneumonia, wound infection, thromboembolism, stroke).

Ambulation at 60 days is known to be highly predictive of ultimate functional outcome as well as of mortality at one year. Because inability to walk has such important implications for quality of life, and because it is a common problem, it far outweighs the small risk of viral infection or other complications from transfusion in elderly patients.

The trial will also evaluate the effect of transfusion threshold on postoperative risk of acute cardiac ischemia. The strategy will be to enhance surveillance for ischemic events by increasing the number of EKG and serum troponin measurements beyond those already called for in the original FOCUS protocol.

There is an ancillary study to the trial (R01 HL085706) to examine delirium as an outcome in a subsample of 139 patients. We will assess short-term (in hospital) and longer-term (after 30 days) severity of delirium.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Anemia
  • Hematologic Diseases
  • Cardiovascular Diseases
  • Heart Diseases
  • Myocardial Infarction
  • Thromboembolism
  • Pneumonia
  • Cerebrovascular Accident
Intervention  ICMJE
  • Biological: Liberal (10 g/dL) Transfusion Strategy
    This transfusion strategy will maintains postoperative Hgb levels above 10 g/dL. This threshold strategy will use 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.
  • Biological: 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.
Study Arms  ICMJE
  • Experimental: Liberal (10 g/dL) Transfusion Strategy
    Transfusion strategy that maintains postoperative Hgb levels above 10 g/dL.
    Intervention: Biological: Liberal (10 g/dL) Transfusion Strategy
  • Active Comparator: 2
    Symptomatic transfusion strategy, a more conservative strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia.
    Intervention: Biological: Restrictive (Symptomatic) Transfusion Strategy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2009)
2016
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has undergone surgical repair for a hip fracture
  • Has a postoperative Hgb level below 10 g/dL within three days of surgery
  • Diagnosis of cardiovascular disease (e.g., coronary artery disease, congestive heart failure, stroke or transient ischemic attack, or peripheral vascular disease) or cardiovascular risk factors (e.g., diabetes mellitus, hypertension, hypercholesterolemia, tobacco use, or creatinine levels greater than 2.0 mg/dL)

Exclusion Criteria:

  • Unable to walk prior to hip fracture
  • Declines blood transfusions
  • Suffered multiple traumas
  • Pathologic fracture of the hip due to malignancy
  • Clinically recognized acute myocardial infarction within the 30 days prior to study entry
  • Previously participated in the trial and fractured the other hip
  • Symptoms associated with anemia (e.g., ischemic chest pain) or actively bleeding at the time of randomization
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00071032
Other Study ID Numbers  ICMJE 159
U01HL073958-06 ( U.S. NIH Grant/Contract )
U01HL073958 ( U.S. NIH Grant/Contract )
U01HL074815 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party rwjmsmedicine, Rutgers, The State University of New Jersey
Study Sponsor  ICMJE Rutgers, The State University of New Jersey
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Study Chair: Jeffrey L. Carson, MD University Medicine & Dentistry of NJ
Principal Investigator: Michael Terrin University of Maryland, College Park
PRS Account Rutgers, The State University of New Jersey
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP