Outcomes of 4-factor Prothrombin Complex Concentrate in Patients With Liver Disease and Nonvitamin K Antagonist-Related Coagulopathy: A Retrospective Study.

The administration of 4-factor prothrombin complex concentrate (4F-PCC) has expanded beyond its Food and Drug Administration (FDA)-approved indication for the emergent reversal of vitamin K antagonists (VKAs). Therefore, this study aimed to evaluate the risks and benefits associated with the expanded use of 4F-PCC. We conducted a single-center retrospective review of 4F-PCC administrations at our university hospital. Of the 159 patients who received 4F-PCC, 76% (n = 121) and 24% (n = 38) received it for the FDA-approved indication in the vitamin K-related coagulopathy (VKA) group and for expanded use in the nonvitamin K-related coagulopathy (nVKA) group, respectively. The expanded use of 4F-PCC was associated with a less robust reduction in the international normalized ratio (INR) (INR of -0.7 ± 1.3 vs INR of -1.6 ± 1.8, P = .002), and fewer patients in the nVKA group achieved a postadministration INR of less than1.5 (11% vs 79%, P = .001) than those in the VKA group. Furthermore, the 30-day mortality rate was significantly higher in the nVKA cohort than in the VKA cohort (42% vs 20%, P = .04). Notably, based on our data, underlying differences in the patient's comorbidities, particularly advanced liver disease, may have contributed to the observed outcome variations, including mortality rate. Therefore, factors, including comorbidities and the underlying etiology of coagulopathy, should be considered when deciding on the expanded use of 4F-PCC. Further research is needed to better understand the potential risks and benefits of 4F-PCC in expanded use scenarios, and the clinical decision to use 4F-PCC outside its FDA-approved indication should be made carefully, considering this information.

Transfusion burden following reduced intensity allogeneic hematopoietic cell transplantation: Impact of donor type.

BACKGROUND: Transfusions are essential for allogeneic hematopoietic cell transplant (HCT), yet they are influenced by graft, donor, and other factors. STUDY DESIGN: We analyzed transfusions in 165 adult reduced intensity HCTs (2016-2019): HLA matched sibling donor (MSD) (n = 59), matched URD (n = 25), UCB (n = 33), and haploidentical (haplo, n = 48) detailing the cumulative incidence of platelet and RBC transfusion independence, total transfusions (day-10 to day+100) plus transfusion densities (per week) over 110 days. RESULTS: Platelet recovery to 20 × 109 /L by 6 months occurred in 39/48 (81.25%) haplo recipients (median 33 [range, 0-139]) days vs. 58/59 (98.3%) MSD (median 10 [0-37]), 21/25 (84%) matched URD (median 20 [0-153]), and 29/33 (87.87%) UCB (median 48 [29-166]) days, p < .01. Regression analysis demonstrated a lower likelihood of prompt platelet recovery in matched URD, UCB, or haplo HCTs vs. MSD. Recovery to platelet independence was quickest in MSD (median 8 days [range 0-94]), vs. URD (median 16 days [0-99]), UCB (median 57 [0-94]), or haplo (median 45 [12-97]) days, p < .01. Platelet needs were unaffected by age, conditioning, or acute GVHD. RBC transfusion independence was achieved in 78% of MSD, 64% URD, and 82% UCB, though less frequent (58%) and slowest in haplo recipients, p < .01. All haplo and UCB recipients required platelet transfusions vs. only 51% of MSD and 76% of URD. RBC needs were highest in UCB and haplo HCTs. DISCUSSION: The transplant donor influences the transfusion burden with greater platelet and RBC needs in haplo and UCB HCT which directly contributes to increased cost of care.

Red blood cell product utilization in patients undergoing allogeneic stem cell transplantation.

BACKGROUND: The risk of transfusion reactions (TR) and the cost of blood has led to efforts to reduce blood use. We changed our practice to transfuse just one instead of two units of red blood cells (RBC) when hemoglobin ≤8 g/dL due to patient blood management (PBM) recommendations. METHODS AND MATERIALS: We compared RBC utilization in patients receiving allogeneic HCT in the 10 months before (control arm) and 13 months after implementation of this new practice (intervention arm). We used regression models to estimate the independent effect of transfusion practice, length of hospitalization, the conditioning regimen, and donor type for patients who received at least one RBC unit. The outcome variable was total number of inpatient transfusions. In addition, a survey assessed the impact of this. RESULTS: Cohorts were matched for age, primary diagnosis, graft source, and conditioning regimen. The median number of RBC units transfused/patient was identical in both arms (4; interquartile range 19 units/patient). Using the regression model, only length of stay (relative increase of 1.035 units/day; 95%CI, 1.0271.043) was an independent predictor of the number of RBC units a patient received. When data were normalized/1000 patient days, the control arm received 240 units vs the intervention arm, which received 193 units, resulting in a reduction of 47 units transfused/1000-patient-days, which was not statistically significant (p-value = 0.32). The survey of RNs showed that it positively affected the workflow. CONCLUSIONS: There was a modest reduction in RBC utilization based on units transfused/1000-patient-days. There was a positive impact on RN workflow.

The Crossmatch/Issue Ratio: Use of a Novel Quality Indicator and Results of an International Survey on RBC Crossmatching and Issuing Practices.

OBJECTIVES: To understand the worldwide scope of RBC crossmatching and issuing practices and measure efficiency using a novel quality indicator, the crossmatch/issue (C/I) ratio. METHODS: An electronic survey was disseminated to hospital transfusion services collecting details about RBC crossmatching and issuing practices. Respondents were asked to enumerate the number of RBCs crossmatched and issued at their institutions during the 2014 calendar year to calculate the C/I ratio. RESULTS: Fifty-two survey responses were received, mostly from North American transfusion services (28/52, 54%). The electronic crossmatch was the most common technique (n = 29), and most respondents performed the crossmatch at the time that an order for RBCs was received in the transfusion service (even if an order to issue the RBCs was not received). Data to calculate the C/I ratio were supplied by 22 respondents, and the mean ± SD was 1.30 ± 0.34. There was no difference in C/I ratios between services that use the electronic or serologic crossmatch techniques (P = .49). The ratio was the same at the four sites that crossmatch RBCs at the time of issue compared with the time of order receipt (mean ± SD, 1.11 ± 0.09 vs. 1.35 ± 0.36, respectively; P = .19). CONCLUSIONS: Electronic crossmatching is common, and the C/I ratio can be an indicator of efficiency.

A data-driven approach to patient blood management.

BACKGROUND: Patient blood management (PBM) has become a topic of intense interest; however, implementing a robust PBM system in a large academic hospital can be a challenge. In a joint effort between transfusion medicine and information technology, we have developed three overlapping databases that allow for a comprehensive, semiautomated approach to monitoring up-to-date red blood cell (RBC) usage in our hospital. Data derived from this work have allowed us to target our PBM efforts. STUDY DESIGN AND METHODS: Information on transfusions is collected using three databases: daily report, discharge database, and denominator database. The daily report collects data on all transfusions in the past 24 hours. The discharge database integrates transfusion data and diagnostic billing codes. The denominator database allows for rate calculations by tracking all patients with a hemoglobin test ordered. A set of algorithms is applied to automatically audit RBC transfusions. The transfusions that do not fit the algorithms' rules are manually reviewed. Data from audits are compiled into reports and distributed to medical directors. Data are also used to target education efforts. RESULTS: Since our PBM program began, the percentage of appropriate RBC orders increased from an initial 70%-80% to 90%-95%, and the overall RBC transfusions/1000 patient-days has decreased by 67% in targeted areas of the hospital. Our PBM program has shaved approximately 3% from our hospital's blood budget. CONCLUSION: Our semiautomated auditing system allows us to quickly and comprehensively analyze and track blood usage throughout our hospital. Using this technology, we have seen improvements in our hospital's PBM.

Hemolytic anemia due to passenger lymphocyte syndrome in solid malignancy patients treated with allogeneic natural killer cell products.

BACKGROUND: Allogeneic natural killer (NK) cell products for treatment of solid organ malignancies were prepared by performing T (CD3+)-cell depletion on nonmobilized apheresis mononuclear cell collections. The products were not B-cell depleted. This report details two cases of passenger lymphocyte syndrome (PLS) after NK-cell infusion. CASE REPORTS: Patient 1 is a blood group A+ 56-year-old female with Stage IV ovarian carcinoma who received NK cells from an O+ donor. On day +7 she developed new hemolytic anemia. Direct antiglobulin test (DAT) was positive for immunoglobulin G and C3, and the eluate contained anti-A. Subsequently, anti-A was identified on reverse typing. She was transfused with group O red blood cells (RBCs). By day +12 she forward typed as O with anti-A and B on reverse typing. By day +42, DAT was negative with only weak anti-A on reverse typing. Patient 2 is a blood group B+ 51-year-old female with metastatic lobular breast carcinoma who received NK cells from an O+ donor. On day +7 she developed new hemolytic anemia. DAT was positive, and the eluate contained anti-A and -B. Anti-A reactivity was due to anti-A,B. The next day she developed new anti-B on reverse typing. She was transfused with O RBCs. Anti-B titer increased to a maximum of 512 on day +12. At discharge on Day +29 her anti-B titer was still 32. CONCLUSIONS: These patients developed PLS after infusion of NK cells. Because of these cases NK-cell products are now B (CD19+)-cell depleted at our institution, and this approach is recommended for other centers.