A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Preoperative Antithrombin Supplementation in Patients at Risk for Antithrombin Deficiency After Cardiac Surgery.

BACKGROUND: Antithrombin (AT) activity is reduced during cardiac operations with cardiopulmonary bypass (CPB), which is associated with adverse outcomes. Preoperative AT supplementation, to achieve >58% and <100% AT activity, may potentially reduce postoperative morbidity and mortality in cardiac operations with CPB. This prospective, multicenter, randomized, double-blind, placebo-controlled study was designed to evaluate the safety and efficacy of preoperative treatment with AT supplementation in patients at risk for low AT activity after undergoing cardiac surgery with CPB. METHODS: A total of 425 adult patients were randomized (1:1) to receive either a single dose of AT (n = 213) to achieve an absolute increase of 20% above pretreatment AT activity or placebo (n = 212) before surgery. The study duration was approximately 7 weeks. The primary efficacy end point was the percentage of patients with any component of a major morbidity composite (postoperative mortality, stroke, acute kidney injury [AKI], surgical reexploration, arterial or venous thromboembolic events, prolonged mechanical ventilation, and infection) in the 2 groups. Secondary end points included AT activity, blood loss, transfusion requirements, duration of intensive care unit (ICU), and hospital stays. Safety was also assessed. RESULTS: Overall, 399 patients (men, n = 300, 75.2%) with a mean (standard deviation [SD]) age of 66.1 (11.7) years, with the majority undergoing complex surgical procedures (n = 266, 67.9%), were analyzed. No differences in the percentage of patients experiencing morbidity composite outcomes between groups were observed (AT-treated 68/198 [34.3%] versus placebo 58/194 [29.9%]; P = .332; relative risk, 1.15). After AT infusion, AT activity was significantly higher in the AT group (108% [42-143]) versus placebo group (76% [40-110]), and lasted up to postoperative day 2. At ICU, the frequency of patients with AT activity ≥58% in the AT group (81.5%) was significantly higher ( P < .001) versus placebo group (43.2%). Secondary end point analysis did not show any advantage of AT over placebo group. There were significantly more patients with AKI ( P < .001) in the AT group (23/198; 11.6%) than in the placebo group (5/194, 2.6%). Safety results showed no differences in treatment-emergent adverse events nor bleeding events between groups. CONCLUSIONS: AT supplementation did not attenuate adverse postoperative outcomes in our cohort of patients undergoing cardiac surgery with CPB.

A cluster-randomized controlled trial of a blood conservation algorithm in patients undergoing total hip joint arthroplasty.

BACKGROUND: The optimum strategy for reducing allogeneic blood transfusion in patients undergoing total hip joint arthroplasty (THJA) is unknown. STUDY DESIGN AND METHODS: The effectiveness of a comprehensive blood conservation algorithm (BCA) was evaluated by means of a cluster randomization trial. Thirty hospitals performing primary THJA were randomly assigned to implement the algorithm or to continue with usual care (UC). Subsequently, the institutional rate of allogeneic transfusion was determined for 60 consecutive patients who underwent surgery at each site. The BCA consisted of patient and provider education, hemoglobin-based recommendations for specific blood conservation strategies (recombinant human erythropoietin [rHuEPO] or autologous blood donation [ABD]) and transfusion guidelines. The main outcome measure was the institutional allogeneic transfusion rate. RESULTS: One hospital withdrew consent after randomization, resulting in 14 hospitals assigned to BCA and 15 to UC. In the BCA arm, the institutional rates of rHuEPO use and ABD participation were 20.1 and 27.1 percent compared to 0.6 and 25.8 percent, respectively, in the UC arm. The allogeneic transfusion rate was substantially reduced in hospitals assigned to the BCA group (p = 0.02; absolute risk reduction, 9.6% [26.1% UC vs. 16.5% BCA]). Multivariate analysis of patient-level data showed that assignment to the UC arm was an independent risk factor for allogeneic transfusion (p = 0.037; odds ratio, 1.8; 95% confidence interval, 1.0-3.1) when adjusted for other prognostic factors. No differences were observed in the use of autologous blood. CONCLUSION: A comprehensive approach to blood conservation was superior to UC for reducing allogeneic transfusion in patients undergoing THJA.

Acupressure wristbands for the prevention of postoperative nausea and vomiting in adults undergoing cardiac surgery.

OBJECTIVE: To determine whether the application of acupressure bands would lead to a reduction in postoperative nausea and vomiting after cardiac surgery. DESIGN: Prospective, randomized, double-blind clinical trial. SETTING: University-affiliated tertiary care teaching hospital. PARTICIPANTS: Adult patients undergoing cardiac surgery. INTERVENTIONS: One hundred fifty-two patients were enrolled to receive either acupressure treatment (n = 75) or placebo (n = 77). All patients had acupressure bands placed on both wrists before induction of anesthesia; those in the treatment group had a bead placed in contact with the P6 point on the forearm. MEASUREMENTS AND MAIN RESULTS: Patients were assessed for nausea, vomiting, and pain scores during the first 24 hours of the postoperative period. The incidences of nausea, vomiting, pain scores, and analgesic and antiemetic requirements were similar between the 2 groups. A subgroup analysis by gender implied that acupressure treatment may be effective only in female patients. CONCLUSION: Acupressure treatment did not lead to a reduction in nausea, vomiting, or antiemetic requirements in patients after cardiac surgery.

Transfusion practices for elective orthopedic surgery.

BACKGROUND: Use of blood conservation techniques in elective surgery reduces the risk of infection and transfusion reactions that result from using allogeneic blood products. We examined the transfusion practice and blood conservation strategies for elective orthopedic procedures in 19 Canadian hospitals. METHODS: We reviewed the medical records of patients who underwent total hip or knee joint arthroplasty between June 1998 and January 1999 in a convenience sample of 19 hospitals to determine the pre- and postoperative hemoglobin concentrations, concurrent medical conditions, participation status in an autologous blood donation program, use of other blood conservation techniques, and occurrence of allogeneic and autologous transfusions. Patients were considered eligible for autologous blood donation if they weighed at least 25 kg, were in good general health without major cardiac conditions and had a hemoglobin concentration of at least 110 g/L. RESULTS: We reviewed 4535 medical records. Of the 4422 patients whose eligibility status was known, 2561 (57.9%) were eligible to participate in an autologous blood donation program. Only 842 (18.6%) of the patients predonated blood. Patients who did not predonate blood were older (mean age 70.1 v. 63.8 years) and were more likely to have concomitant medical conditions (60.3% v. 37.9%) than those who did predonate. Overall, 30.6% (95% confidence interval [CI] 29.1%-32.1%) of the patients who did not predonate blood received allogeneic transfusions. For patients who predonated, the rate of allogeneic transfusion was 14.1% (95% CI 11.8%-16.5%). The frequency with which blood conservation techniques other than autologous blood donation were used was minimal (in 2.4% of all cases). INTERPRETATION: The use of blood conservation techniques among hospitals in Canada remains low. Only a minority of eligible patients participated in an autologous blood donation program.