On-label compared to off-label four-factor prothrombin complex concentrate use: a retrospective, observational study.

BACKGROUND: Four-factor prothrombin complex concentrate (4F-PCC) is US Food and Drug Administration approved for the urgent reversal of coagulation factor deficiency induced by a vitamin K antagonist complicated by acute major bleeding or in situations in which invasive procedures are urgently needed. Although recent evidence suggests the superiority of 4F-PCC over plasma for on-label indications, the off-label use of 4F-PCC has not been rigorously studied. STUDY DESIGN AND METHODS: Eighty-nine patients receiving 4F-PCC at a single institution from July 2016 to December 2017 were retrospectively analyzed. Two cohorts, "On-Label" and "Off-Label" uses of 4F-PCC, were evaluated, comparing patient characteristics, blood utilization, and clinical outcomes including in-hospital mortality. RESULTS: Patients receiving 4F-PCC for off-label reasons (n = 46) were younger and sicker compared to those receiving 4F-PCC for on-label reasons (n = 43). Notably, the mortality rate for off-label use was approximately twofold greater than the mortality rate for on-label use (26 of 46 [56.5%] vs. 12 of 43 [27.9%]; p = 0.006). Patients receiving 4F-PCC for off-label reasons received more units per patient of each blood component than their on-label counterparts. The average cost estimate per patient for 4F-PCC was similar (approx. $4300) in each cohort. CONCLUSION: 4F-PCC is an effective but expensive treatment option for those requiring urgent reversal of vitamin K antagonist-induced coagulopathy. However, providers should be conscious of the high costs and questionable efficacy when using 4F-PCC off-label.

One-unit compared to two-unit platelet transfusions for adult oncology outpatients.

BACKGROUND AND OBJECTIVES: Platelet dosing has been studied in adult oncology inpatients, but there is almost no published evidence to guide platelet dosing for adult outpatients. We evaluated transfusion indices after 1 unit and 2 unit apheresis platelet transfusions at our hospital to determine whether a benefit to 2-unit transfusions could be detected. MATERIALS AND METHODS: A retrospective chart review was conducted of all adult oncology patients who received an outpatient platelet transfusion over a 16-month period (July 2016-November 2017). Pre- and post-transfusion platelet count, and chronology of subsequent platelet transfusions were compared. RESULTS: A total of 8467 platelet transfusions were administered to 602 patients during the study period. 59·8% of patients (n = 360) were transfused interchangeably with one or two platelets throughout the study period. The primary study population were comprised of these patients. On average, a 2-unit platelet transfusions resulted in a higher immediate post-transfusion platelet count (43 vs. 37 x 103 /µl, P < 0·001) and a lower corrected count increment (9707 vs. 14 060, P < 0·001). Transfusion with 2 platelets did not increase the number of days between outpatient transfusions (median; 4 vs. 4, P = 0·959) or the platelet count at the time of next transfusion (11 vs. 11 x 103 /µl, P = 0·147). CONCLUSION: Among adult, oncology outpatients that were transfused interchangeably with one or two units of platelets, transfusion with two platelets did not offer a durable improvement in platelet count or impact the subsequent transfusion schedule.

Implementation of a Blood Management Program at a Tertiary Care Hospital: Effect on Transfusion Practices and Clinical Outcomes Among Patients Undergoing Surgery.

BACKGROUND: Patient blood management (PBM) programs represent a perioperative bundle of care that aim to reduce or eliminate unnecessary transfusions. OBJECTIVE: To evaluate the impact of a PBM program on transfusion practices and clinical outcomes at a single surgical department at a tertiary care hospital in the United States. METHODS: This pre-post, cross-sectional study was performed using data from 17,114 patients undergoing gastrointestinal surgery between 2010 and 2013. Multivariable regression analysis was used to evaluate the impact of implementing a PBM program on transfusion practices and perioperative clinical outcomes. RESULTS: Implementation of the PBM program was associated with a reduction in the proportion of patients receiving packed red blood cell (PRBC) using a liberal trigger hemoglobin concentration (pre-PBM vs post-PBM: trigger ≥8.0 g/dL: 20.2% vs 15.3%, P < 0.001), as well as an increase in the proportion of patients receiving PRBC using a restrictive trigger hemoglobin concentration (trigger <7.0 g/dL: 37.1% vs 46.4%, P < 0.001). The proportion of patients overtransfused to a target hemoglobin concentration of 9.0 g/dL (54.8% vs 43.9%, P < 0.001) or 10.0 g/dL (22.3% vs 15.8%, P < 0.001) also decreased following implementation of the PBM program. On multivariable analysis, implementation of the PBM program was associated with 23% lower odds of receiving PRBC transfusion (odds ratio = 0.77, 95% confidence interval 0.657-0.896, P = 0.001); hospital length-of-stay, postoperative morbidity, and postoperative mortality were unchanged (all P > 0.05). CONCLUSIONS: Implementation of a PBM program was associated with fewer patients receiving PRBC transfusion using a liberal trigger hemoglobin concentration and fewer patients being "overtransfused," without any detectable change in length-of-stay, morbidity or mortality. PBM programs can be safely implemented across hospitals and should be used to improve quality and reduce unnecessary transfusions.

A Restrictive Hemoglobin Transfusion Threshold of Less Than 7 g/dL Decreases Blood Utilization Without Compromising Outcomes in Patients With Hip Fractures.

INTRODUCTION: In patients with hip fracture, a transfusion threshold of hemoglobin (Hb) <8 g/dL is associated with similar or better outcomes than more liberal thresholds. Whether a more restrictive threshold of <7 g/dL Hb produces equivalent outcomes in such patients is unknown. The aim of the study was to examine whether a restrictive threshold of <7 g/dL Hb is safe in this population. METHODS: In January 2015, a blood management program was implemented that uses a restrictive transfusion threshold of <7 g/dL Hb in hemodynamically stable patients and <8 g/dL in patients with symptomatic anemia or a history of coronary artery disease. We identified 498 patients treated for hip fractures from January 2013 through May 2017. We compared perioperative outcomes of 207 patients treated before with those of 291 patients treated after restrictive threshold implementation. RESULTS: After restrictive threshold implementation, the proportion of patients receiving packed red blood cell (PRBC) transfusions decreased from 51% to 33% (P < 0.001); the mean number of PRBC units transfused per patient decreased by 40% (from 1.1 to 0.7; P < 0.001); inpatient cardiac morbidity decreased from 22.2% to 12.4% (P = 0.004); 30-day readmissions decreased from 14% to 8.6% (P = 0.04); and length of stay was unchanged (P = 0.06). Compared with the prerestrictive threshold cohort, the postrestrictive threshold group had lower odds of transfusion (odds ratio [OR] = 0.42; 95% confidence interval [CI], 0.29 to 0.62); transfusion of >1 unit of PRBCs (OR = 0.34; 95% CI, 0.22 to 0.52); and inpatient cardiac morbidity (OR = 0.45; 95% CI, 0.27 to 0.75). No significant differences were observed in inpatient morbidity, mortality, 30-day readmission, or 90-day survival. DISCUSSION: A restrictive threshold of <7 g/dL Hb in hemodynamically stable patients with hip fractures is associated with noninferior perioperative outcomes and less blood utilization compared with a threshold of <8 g/dL. LEVEL OF EVIDENCE: Level III, retrospective cohort study.

Discharge Hemoglobin Level and 30-Day Readmission Rates After Coronary Artery Bypass Surgery.

BACKGROUND: Restrictive transfusion strategies supported by large randomized trials are resulting in decreased blood utilization in cardiac surgery. What remains to be determined, however, is the impact of lower discharge hemoglobin (Hb) levels on readmission rates. We assessed patients with higher versus lower Hb levels on discharge to compare 30-day readmission rates after coronary artery bypass grafting (CABG). METHODS: We retrospectively evaluated 1552 patients undergoing isolated CABG at our institution from January 2013 to May 2016. We evaluated 2 Hb cohorts: "high" (above) and "low" (below) the mean discharge Hb level of 9.4 g/dL, comparing patient characteristics, blood utilization, and clinical outcomes including 30-day readmission rates. We further evaluated the effects of the lowest (<8 g/dL) discharge Hb levels on 30-day readmission rates by dividing the patients into 4 anemia cohorts based on discharge Hb levels: "no anemia" (>12 g/dL), "mild anemia" (10-11.9 g/dL), "moderate anemia" (8-9.9 g/dL), and "severe anemia" (<8 g/dL). Risk adjustment accounted for age, sex, Charlson comorbidity index, preoperative comorbidities, revision sternotomy, and patient blood management program implementation. RESULTS: The "high" and "low" groups had similar patient characteristics except for Hb levels (mean discharge Hb was 10.4 ± 0.9 vs 8.5 ± 0.6 g/dL, respectively). Notably, no evidence for a difference in 30-day readmission rates was noted between the "high" (76/746; 10.2%) and "low" (97/806; 12.0%) (P = .25) Hb cohorts. The 4 anemia cohorts had differences in age, revision sternotomy incidence, Hb levels, certain patient comorbidities, and time to readmission. On multivariable analysis, the risk-adjusted odds of readmission in the "low" Hb cohort (odds ratio, 1.16; 95% confidence interval, 0.84-1.61; P = .36) was not significant compared to the "high" Hb cohort. Compared to patients with discharge Hb ≥8 g/dL, patients with Hb <8 g/dL had a higher incidence of readmission (22/129; 17.1% vs 151/1423; 10.6%; P = .036). On multivariable analysis, Hb <8 g/dL on discharge was predictive of readmission (odds ratio, 1.77; 95% confidence interval, 1.05-2.88; P = .03). The most common reason for readmission was volume overload, followed by infection and arrhythmias. CONCLUSIONS: A discharge Hb level below the institution mean for CABG patients does not provide evidence for an association with an increased 30-day readmission rate. In the small number of patients discharged with Hb <8 g/dL, there is a suggestion of increased risk for readmission and larger more controlled studies are needed to verify or refute this finding.

Blood utilization and mortality in victims of gun violence.

BACKGROUND: Blood transfusion can be lifesaving for patients with hemorrhage; however, transfusion requirements for victims of gun violence are poorly understood. STUDY DESIGN AND METHODS: In an urban, Level 1 trauma center, 23,422 trauma patients were analyzed in a retrospective cohort study. Patients with gunshot wounds (GSWs) (n = 2,672; 11.4% of trauma patients) were compared to those with non-GSW traumatic injuries from 2005 to 2017, to assess blood utilization. RESULTS: The GSW cohort was approximately five times more likely to require transfusion (538 of 2672 [20.1%] vs. 798 of 20,750 [3.9%]; p < 0.0001), and the number of blood component units transfused per patient was approximately 10 times greater (3.3 ± 13.5 vs. 0.31 ± 3.8 units/patient; p < 0.0001), compared to the non-GSW cohort. The risk-adjusted likelihood of requiring high-dose transfusion was greater in the GSW cohort (odds ratio, 2.38; 95% confidence interval, 1.14-5.80), and requirements were increased for all four blood components (red blood cells, platelets, plasma, and cryoprecipitate). Patients with GSWs had approximately 14 times greater overall mortality (653 of 2672 [24.4%] vs. 352 of 20,750 [1.7%]; p < 0.0001]. Compared to non-GSW penetrating injuries (e.g., stab wounds), those with GSWs had approximately four times higher transfusion requirements (3.3 ± 13.5 vs. 0.80 ± 3.8 units/patient; p < 0.0001), and approximately eight times greater overall mortality (653 of 2672 [24.4%] vs. 28 of 956 [2.9%]; p < 0.0001). CONCLUSIONS: Compared to other traumatic injuries, GSW injuries are associated with substantially greater blood utilization and mortality. Trauma centers treating GSW injuries should have ready access to all blood components and ability to implement massive transfusions.