Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients With Cardiovascular Disease - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00071032

Purpose

The purpose of this study is to compare aggressive red blood cell transfusion therapy with conservative therapy in surgical patients with cardiovascular disease.

Condition	Intervention	Phase
Anemia Hematologic Diseases Blood Transfusion Cardiovascular Diseases Heart Diseases Myocardial Infarction Thromboembolism Pneumonia Cerebrovascular Accident	Procedure: Aggressive Red Blood Cell Transfusion Strategy Procedure: Symptomatic Transfusion Strategy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS)

Resource links provided by NLM:

MedlinePlus related topics: Anemia Blood Transfusion and Donation Heart Attack Heart Diseases Pneumonia Surgery

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Ability to walk 10 feet across a room without human assistance [ Time Frame: Measured 60 days after study entry ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Myocardial infarction or death [ Time Frame: in-hospital ] [ Designated as safety issue: No ]
Postoperative complications (e.g., pneumonia, thromboembolism, stroke) [ Time Frame: In hospital ] [ Designated as safety issue: No ]
Survival [ Time Frame: 60 day and long term up to 5 years ] [ Designated as safety issue: No ]
Nursing home placement [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Function (e.g., activities of daily living, instrumental activities of daily living, fatigue) [ Time Frame: 30 and 60 days ] [ Designated as safety issue: No ]

Enrollment:	2016
Study Start Date:	July 2003
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will undergo a transfusion strategy that maintains postoperative Hgb levels above 10 g/dL.	Procedure: Aggressive Red Blood Cell 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.
2: Active Comparator Participants will undergo a symptomatic transfusion strategy, a more conservative strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia.	Procedure: 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.

Arms

Assigned Interventions

1: Experimental

Participants will undergo a transfusion strategy that maintains postoperative Hgb levels above 10 g/dL.

Procedure: Aggressive Red Blood Cell 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.

2: Active Comparator

Participants will undergo a symptomatic transfusion strategy, a more conservative strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia.

Procedure: 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.

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Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00071032

Locations

United States, New Jersey
University Medicine & Dentistry of NJ
New Brunswick, New Jersey, United States, 08903

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Study Chair:	Jeffrey L. Carson, MD	University Medicine & Dentistry of NJ
Principal Investigator:	Michael Terrin	University of Maryland

More Information

Additional Information:

FOCUS Trial Web Site This link exits the ClinicalTrials.gov site

Publications:

Carson JL, Terrin ML, Magaziner J, Chaitman BR, Apple FS, Heck DA, Sanders D; FOCUS Investigators. Transfusion trigger trial for functional outcomes in cardiovascular patients undergoing surgical hip fracture repair (FOCUS). Transfusion. 2006 Dec;46(12):2192-206. Review. No abstract available.

Responsible Party:	University Medicine & Dentistry of NJ ( Jeffrey L. Carson, MD )
Study ID Numbers:	159, U01 HL73958, U01 HL74815
Study First Received:	October 9, 2003
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00071032 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Blood Disease

Study placed in the following topic categories:

Cerebral Infarction
Myocardial Ischemia
Fractures, Bone
Benzocaine
Brain Diseases
Cerebrovascular Disorders
Thromboembolism
Hip Fractures
Necrosis
Respiratory Tract Diseases
Respiratory Tract Infections
Brain Ischemia
Myocardial Infarction
Heart Diseases

Hematologic Diseases
Stroke
Anemia
Vascular Diseases
Central Nervous System Diseases
Ischemia
Thrombosis
Embolism and Thrombosis
Embolism
Lung Diseases
Brain Infarction
Infarction
Pneumonia

Additional relevant MeSH terms:

Cerebral Infarction
Myocardial Ischemia
Brain Diseases
Cerebrovascular Disorders
Thromboembolism
Necrosis
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Brain Ischemia
Cardiovascular Diseases
Myocardial Infarction
Heart Diseases

Hematologic Diseases
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Ischemia
Thrombosis
Embolism and Thrombosis
Lung Diseases
Brain Infarction
Infarction
Pneumonia

ClinicalTrials.gov processed this record on September 03, 2009