Project Details


DESCRIPTION (provided by applicant); Red blood cell transfusions are an
extremely common medical intervention in both the United States and worldwide;
over 11 million units are transfused in the United States. Between 60% and 70%
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 current standard of care today to
administer blood transfusions based on the presence of symptoms and not a
specific Hgb/hematocrit level. However, there are no randomized clinical
trials in 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.
We propose to conduct a multi-center randomized trial to test if a more
aggressive transfusion strategy that maintains postoperative Hgb levels above
10 g/dl improves patient outcome as compared to a more conservative strategy
that withholds blood transfusion until the patient develops symptoms of
anemia. Eligible patients for the trial will have undergone surgical repair
for a hip fracture and have a postoperative Hgb level below 10 g/dl within
three days of surgery. Only patients with cardiovascular disease will be
entered into the study. Patients will be randomized to one of the two
transfusion strategies. The 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. 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 ten feet across
a room without human assistance at 60-days post-randomization), long-term
survival, nursing home placement, and postoperative complications (death in
hospital or within 30 days, pneumonia, myocardial infarction, thromboembolism,
stroke, delirium). We will randomize 2,600 patients from 25 centers over a
3.5-year period. This will allow us to detect a 16% relative risk reduction in
the loss of ability to walk independently with power about 0.90. A pilot study
in 84 patients demonstrated the feasibility of the study. 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 again
has such important implications for quality office, and because,
unfortunately, it is a common problem, it far outweighs the remote chance of
viral infection or other complications from transfusion in these elderly
Also, this study will measure the frequency and 95% confidence intervals of
the medical errors that are important in this patient population and are
poorly documented in the literature. The medical errors that will be measured
are: transfusion errors (blood transfusion to the wrong patient, mislabeling
of samples for type and cross match, use of whole blood instead of packed red
cells), failure to use thromboembolism prophylaxis, incorrect antibiotic
prophylaxis, wrong site surgery and femoral shaft fracture.
Effective start/end date9/1/038/31/12


  • National Institutes of Health: $146,965.00
  • National Institutes of Health: $251,953.00
  • National Institutes of Health: $1,242,679.00
  • National Institutes of Health: $1,045,488.00
  • National Institutes of Health: $2,002,450.00
  • National Institutes of Health: $948,145.00
  • National Institutes of Health: $1,532,837.00
  • National Institutes of Health: $1,384,516.00


  • Medicine(all)

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