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2370 Part XIII: Transfusion Medicine Chapter 138: Blood Procurement and Red Cell Transfusion 2371

TABLE 138–3. Incidence of Transfusion-Transmitted Diseases
Data from Strong and Data from Dodd, Notari,
Katz (2002) 75 and Stramer (2002) 18 Data from Tabor (2002) 77 Total U.S. Cases*
Hepatitis C 1/1,200,000 1/1,935,000 1/625,000 8
Hepatitis B 1/150,000 — 1/150,000 80 †
HTLV-I/HTLV-II 1/641,000 — — 20 †
HIV 1/1,400,000 1/2,135,000 1/769,230 7
HTLV, human T-cell lymphotropic virus.
*Calculated based on transfusion of 15,000,000 U of blood annually and Dodd incidence figures.
76
† Calculations based on data from Strong and Katz. 75

with upper gastrointestinal bleeding, cardiovascular risk factors, ortho- did not receive RBC transfusions (p <0.001). These two major trials
pedic surgery patients and other populations that usually require a large demonstrated that a 7 g/dL Hgb threshold was safe for a variety of crit-
number of RBC transfusions. All studies followed the basic structure of ically ill patients.
the TRICC trial, randomizing patients into a restrictive versus liberal
arm. Most studies also used mortality or end-organ dysfunction as end RED BLOOD CELL TRANSFUSIONS
points.
A total of 899 patients with an upper gastrointestinal bleed were FOR CARDIOVASCULAR PATIENTS
randomized so that the restrictive arm had a transfusion threshold of Moderate anemia may lead to increased rates of myocardial ischemia
20
7 g/dL versus a Hgb level of 9 g/dL for the liberal arm. Death from any and infarction in patients with cardiovascular risk factors. Several stud-
cause within the first 45 days was the primary outcome, and the rate of ies were designed to test whether lower transfusion thresholds were del-
further bleeding and in-hospital complications were used as secondary eterious in this patient population. A subgroup analysis of the TRICC
outcomes. The two patient groups had similar characteristics, including trial found that patients with cardiovascular disease had similar out-
equivalent numbers and grades of cirrhosis. The results of this study comes in the restrictive and liberal cohorts; however, the rate of patients
also favored a restrictive transfusion strategy. The probability of survival suffering from acute pulmonary edema was significantly higher in the
at 6 weeks was higher in the restrictive strategy group (p = 0.02) and liberal transfusion arm. 21
the risk of further bleeding was lower (p = 0.01). Overall adverse events The Transfusion Trigger Trial for Functional Outcomes in Cardio-
were also lower in the restrictive group when compared to the liberal vascular Patients Undergoing Surgical Hip Fracture Repair (FOCUS
transfusion arm (p = 0.02). The rate of survival was slightly higher in trial) compared the transfusion thresholds of 10 g/dL versus less than
the restrictive group compared to the liberal group for patients with 8 g/dL in patients who were status post–hip fracture repair and had car-
22
peptic ulcers (hazard ratio, 0.70; 95 percent confidence interval [CI], diovascular risk factors. The trial enrolled 2016 patients older than 50
0.26 to 1.25); and was significantly higher in patients with cirrhosis and years of age who were randomized into the restrictive or liberal transfu-
Child-Pugh class A or B disease (hazard ratio, 0.30; 95 percent CI, 0.11 sion threshold group. The primary outcome was death or an inability to
to 0.85). No difference was found for cirrhosis patients and Child-Pugh walk across a room without human assistance on 60-day followup. Sec-
class C disease (hazard ratio 1.04; 95 percent CI, 0.45 to 2.37). As with ondary outcomes included in-hospital myocardial infarction, unstable
the TRICC study, a highly significant difference in transfusion rates was angina, or death for any reason. The liberal transfusion strategy, when
reported. In the restrictive arm, 51 percent of patients did not receive a compared with the restrictive strategy, did not reduce rates of death or
transfusion, compared to 15 percent of patients in the liberal arm who inability to walk independently at 60-day followup or reduce in-hospital

TABLE 138–4. Major Randomized Controlled Trials for Safe Hemoglobin Thresholds in Adults
Number Hgb/Hct Thresholds
Trial Patient Population Enrolled (Rest/Lib) Primary End Point Conclusions
TRICC 93 ICU 838 7/10 g/dL 30-Day all-cause Restrictive strategy as effective
mortality and possibly superior to liberal
strategy
FOCUS 97 History or risk factor for 2016 8/10 g/dL 60-Day all-cause Liberal strategy did not reduce
CV disease following hip mortality or inability death rates or inability to walk
fracture surgery to walk 10 ft
TRACS 98 Cardiac surgery 502 24/30 percent 30-Day all-cause Restrictive strategy was nonin-
mortality and severe ferior to liberal strategy
morbidity
Upper GI bleed 94 Severe acute upper GI 921 7/9 g/dL 45-Day all-cause Restrictive strategy improved
bleed mortality outcomes compared with
liberal
CV, cardiovascular; FOCUS, Functional Outcomes in Cardiovascular Patients Undergoing Surgical Hip Fracture Repair; GI, gastrointestinal; Hct,
hematocrit; Hgb, hemoglobin; TRACS, Transfusion Requirements After Cardiac Surgery; TRICC, Transfusion Requirements in Critical Care.

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