Information for Health Professionals: Detailed Description
The overall goal is to determine whether a more aggressive transfusion
strategy in patients with cardiovascular disease undergoing surgery
for repair of hip fracture is associated with improved functional
recovery and decreased risk of adverse postoperative outcomes. The
specific aims of the study are:
To determine if a 10 g/dl transfusion strategy is associated with
improved ability to walk ten feet across a room without human assistance
60-days after surgery compared to a symptomatic transfusion strategy.
- Secondary Aims:
- To determine if a 10 g/dl transfusion strategy
is associated with lower risk of postoperative myocardial
infarction or death after surgery compared to a symptomatic
transfusion strategy
- To determine if a 10 g/dl transfusion strategy
is associated with a decreased risk of postoperative
30-day and long term mortality compared to a symptomatic
transfusion strategy.
- To determine if a 10 g/dl transfusion strategy
is associated with improved lower extremity function
and instrumental activities of daily living 30 and
60-days after surgery compared to a symptomatic transfusion
strategy.
- To determine if a 10 g/dl transfusion strategy
is associated with fewer patients remaining in a
nursing home 60-days after surgery compared to a
symptomatic transfusion strategy.
- Tertiary Aims:
- To determine if a 10 g/dl transfusion strategy
is associated with a decreased risk of in-hospital
postoperative non-infectious morbidity compared to
a symptomatic transfusion strategy. Specific
morbid outcomes to be assessed are delirium, stroke,
and thromboembolism.
- To determine if a 10 g/dl transfusion strategy
is associated with an increased risk of in-hospital
postoperative pneumonia.
- To determine if a 10 g/dl transfusion strategy
is associated with decreased risk of composite outcome
of 30-day mortality, myocardial infarction, pneumonia,
stroke, and thromboembolism.
- To assess the frequency of selected medical errors
in a frail, elderly population.
- To identify patient characteristics that are predictive
of successful rehabilitation.
- Background and Significance
Blood transfusions should be prescribed only after a careful consideration
of the risks versus the benefits of the therapy. Recent studies
document an extremely low rate of adverse effects, which include
errors of administration, transmission of infectious diseases, volume
overload and others. The well accepted benefit of blood transfusion
principally relates to the improvement of oxygen carrying capacity.
However, no large scale randomized controlled trials exist in surgical
patients that characterize these clinical benefits and the associated
risks of transfusion. This scientific uncertainty has led to
variation in transfusion practice which has been demonstrated in
surgical patients. Blood transfusion is expensive and widely
used. In the US alone, there are over 13 million units of allogeneic
blood transfused per year at a cost of over 3.4 billion dollars.
- Patient Population
- 2,600 patients with acute hip fracture undergoing
surgical repair.
- Hemoglobin level less than 10 g/dl from the end
of surgery to the 3rd postoperative day.
- Patients are excluded with multiple trauma, active
symptoms from anemia at time of randomization, and
refuse blood transfusion for religious or other reasons.
- Treatments
- 10 g/dL Transfusion. Immediately receives
1 unit of packed red cells. A post-transfusion
hemoglobin level is measured, and the patient receives
as much blood as is necessary to keep the hemoglobin
level above 10 g/dL
- Symptomatic Transfusion. Transfusion is withheld
until the patient develops symptoms from anemia that
the surgeon believes would be treated with blood transfusion
(i.e., chest pain or ECG changes thought to be ischemic,
congestive heart failure, unexplained tachycardia
or hypotension unresponsive to fluids, unable to get
out of bed 3 days after surgery) 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. All patients with a history of
dementia will receive a transfusion when the hemoglobin
level falls below 8g/dL because of the difficulty
in identifying symptoms of anemia. Enough blood
is given to relieve symptoms or to keep hemoglobin
level above 8 g/dL.
- Assignment to Transfusion Group
- Randomization by coordinating center using toll
free (800) telephone number.
- Randomization stratified by clinical center.
- Blinding
- Assignment will not be blinded.
- Primary Outcomes
- At 60 days after surgery, death or inability to
walk 10 feet or across the room (independently or
with the assistance of a mechanical aid).
- Secondary Outcomes
- Myocardial infarction or death
- 30-day and long term mortality
- Lower extremity function and instrumental activities
of daily living 30 and 60-days after surgery.
- Nursing home residence 60-days after surgery.
- Tertiary Outcomes
- Non-infectious morbidity including delirium, stroke,
and thromboembolism.
- Postoperative pneumonia.
- Composite outcome of 30-day mortality, myocardial
infarction, pneumonia, stroke, and thromboembolism.
- Selected medical errors.
- Patient characteristics that is predictive of
successful rehabilitation.
- Outcome Detection and Adherence to Protocol
- Daily in-hospital review of hospital chart by study
personnel.
- Electrocardiogram prior to surgery, postoperative
day 1 and 4 days after randomization. . Troponin
level prior to randomization, day 1 and day 4 post
randomization. Troponin measured by Troponin
Core Laboratory.
- Telephone contact by personnel from study chairman’s
office at 30 and 60 days after surgery.
- Vital statistic registry search for mortality.
- Outcome Classification
- In hospital mortality and secondary outcomes retrieved
by staff at each clinical center. ECG
and MI classification by ECG Core Laboratory
- Post discharge vital status determined by telephone
contact at 30 and 60 days and the National Death Index
and Statistics Canada.
- Primary Analysis
- Intention to treat.
- Comparison of primary outcome using chi square
test with one degree freedom.
- Time Line
- 6 months planning and organization.
- 3.5 years patient enrollment and data collection
- 1 year analysis
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