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The Use of 3- and 4-Factor Prothrombin Complex Concentrate in Patients With Elevated INR

Mohan, Sanjay; Howland, Mary Ann; Lugassy, Daniel; Jacobson, Jessica; Su, Mark K
BACKGROUND: PCC (Kcentra(R)) is an Food and Drug Administration (FDA)-approved 4-factor PCC used for the treatment of warfarin-related coagulopathy (WRC), but it has also been used off-label to treat non-WRC. Three-factor PCC in the form of coagulation factor IX human (Bebulin(R)) has also been used for WRC and off-label to treat non-WRC. It is unclear whether the use of 3- or 4-factor PCCs is effective for the treatment of non-WRC,. OBJECTIVE: Our aim is to characterize the use of 3- and 4-factor PCCs for patients identified with a non-WRC. METHODS: A retrospective analysis of patients who received PCCs for both WRC and non-WRC between January 2012 and July 2015 was conducted. RESULTS: A total of 187 patients with elevated international normalized ratio (INR) who received PCCs were analyzed; 53.9% of patients in the WRC group and 27.7% in the non-WRC group corrected to an INR of 1.3 or less after 3- or 4-factor PCC administration. In those patients with non-WRC and who had underlying liver disease, 3- and 4-factor PCCs reduced mean INR by 0.98 and 1.43, respectively. CONCLUSION: Three and 4-factor PCCs can reduce INR in patients with WRC and in those with non-WRC secondary to liver disease.
PMID: 28468525
ISSN: 1531-1937
CID: 2546612

Addressing the risk of bacterial contamination in platelets: a hospital economic perspective

Li, Justin W; Brecher, Mark E; Jacobson, Jessica L; Harm, Sarah K; Chen, Dorothy; El-Gamil, Audrey; Dobson, Al; Mintz, Paul D
BACKGROUND: Bacterially contaminated platelets (PLTs) remain a serious risk. The Food and Drug Administration has issued draft guidance recommending hospitals implement secondary testing or transfuse PLTs that have been treated with pathogen reduction technology (PRT). The cost implications of these approaches are not well understood. STUDY DESIGN AND METHODS: We modeled incurred costs when hospitals acquire, process, and transfuse PLTs that are PRT treated with INTERCEPT (Cerus Corp.) or secondary tested with the PLT PGD Test (Verax Biomedical). RESULTS: Hospitals will spend $221.27 (30.0%) more per PRT-treated apheresis PLT unit administered compared to a Zika-tested apheresis PLT unit that is irradiated and PGD tested in hospital. This difference is reflected in PRT PLT units having: 1) a higher hospital purchase price ($100.00 additional charge compared to an untreated PLT); 2) lower therapeutic effectiveness than untreated PLTs among hematologic-oncologic patients, which contributes to additional transfusions ($96.05); or 3) fewer PLT storage days, which contributes to higher outdating cost from expired PLTs ($67.87). Only a small portion of the incremental costs for PRT-treated PLTs are offset by costs that may be avoided, including primary bacterial culture, secondary bacterial testing ($26.65), hospital irradiation ($8.50), Zika testing ($4.47), and other costs ($3.03). CONCLUSION: The significantly higher cost of PRT-treated PLTs over PGD-tested PLTs should interest stakeholders. For hospitals that outdate PLTs, savings associated with expiration extension to 7 days by adding PGD testing will likely be substantially greater than the cost of implementing PGD-testing. Our findings might usefully inform a hospital's decision to select a particular blood safety approach.
PMID: 28703862
ISSN: 1537-2995
CID: 2630692

AABB Committee Report: reducing transfusion-transmitted cytomegalovirus infections

Heddle, Nancy M; Boeckh, Michael; Grossman, Brenda; Jacobson, Jessica; Kleinman, Steven; Tobian, Aaron A R; Webert, Kathryn; Wong, Edward C C; Roback, John D
Transfusion-transmitted cytomegalovirus (TT-CMV) is often asymptomatic, but certain patient populations, such as very low birth weight neonates, fetuses requiring intrauterine transfusion, pregnant women, patients with primary immunodeficiencies, transplant recipients, and patients receiving chemotherapy or transplantation for malignant disease, may be at risk of life-threatening CMV infection. It is unclear whether leukoreduction of cellular blood components is sufficient to reduce TT-CMV or whether CMV serological testing adds additional benefit to leukoreduction. The AABB CMV Prevention Work Group commissioned a systematic review to address these issues and subsequently develop clinical practice guidelines. However, the data were of poor quality, and no studies of significant size have been performed for over a decade. Rather than creating guidelines of questionable utility, the Work Group (with approval of the AABB Board of Directors) voted to prepare this Committee Report. There is wide variation in practices of using leukoreduced components alone or combining CMV-serology and leukoreduction to prevent TT-CMV for at-risk patients. Other approaches may also be feasible to prevent TT-CMV, including plasma nucleic acid testing, pathogen inactivation, and patient blood management programs to reduce the frequency of inappropriate transfusions. It is unlikely that future large-scale clinical trials will be performed to determine whether leukoreduction, CMV-serology, or a combination of both is superior. Consequently, alternative strategies including pragmatic randomized controlled trials, registries, and collaborations for electronic data merging, nontraditional approaches to inform evidence, or development of a systematic approach to inform expert opinion may help to address the issue of CMV-safe blood components.
PMID: 26968400
ISSN: 1537-2995
CID: 2024572

Estimated Financial Impact of Complying with the FDA Draft Guidance Entitled "Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion" [Meeting Abstract]

Sorkin, E. J.; Jacobson, J. L.
ISSN: 0041-1132
CID: 2283862

The Cumulative Impact of Prospective Auditing on Decreasing Single-Donor Platelet (SDP) Usage [Meeting Abstract]

Jacobson, J. L.
ISSN: 0041-1132
CID: 2283852

A System-wide Analysis of Red Blood Cell Unit Purchases Following the Adoption of a Corporate-wide Blood Use Policy and Transfusion Guidelines [Meeting Abstract]

Jacobson, J. L.; Ford, K.
ISSN: 0041-1132
CID: 2283842

Adoption of System-wide Delivery Goals and Establishment of a Minimum Par Level Dramatically Altered Platelet-Ordering Practices [Meeting Abstract]

Sorkin, E. J.; Ford, K.; Jacobson, J. L.
ISSN: 0041-1132
CID: 2283882

Transfusion guidelines instruction course and competency exam to address house staff blood banking and transfusion medicine educational deficiencies [Meeting Abstract]

Jacobson, J L
Background/Case Studies: Most United States medical school curricula devote little attention to teaching transfusion medicine (TXNM). From the early stages of their residencies, however, physicians are expected to be able to obtain informed consent for transfusion, administer transfusions, and recognize and treat transfusion reactions. Although there are many transfusion standards designed to ensure patient safety, they also can lead to a false sense of security. The overall limited knowledge of TXNM by most physicians and the reliance on this false sense of security can adversely impact patient safety. In 2010, comprehensive TXNM education was required of all incoming house staff (HS). In 2014, the blood bank staff was able to see the HS's performance question-by-question, and the staff sought to evaluate the impact of the compulsory online education and determine which topics merit additional instruction. Study Design/Methods: An online Transfusion Guidelines tutorial and competency exam, consisting of 25 true/ false questions, was administered. All HS were required to take and pass (score > 80%) the exam. The instruction course and competency exam were accessible to all HS and members of the medical school community on the institution's advanced learning exchange. The competency exams were instantly scored, and the results were reported to the test taker. Results/ Findings: Prior to starting work on July 1, 2014, all incoming HS had taken and scored >80% on the exam. From May1, 2014 to July 1,2014, a total of 977 individuals, including the incoming HS, had completed the tutorial and taken the exam. The average score on the exam was 83.2% (20.8/25). Three questions were answered correctly by <40% of the test-takers. Two questions were answered correctly by 60-69%, 4 questions were answered correctly by 70-79%, 7 questions were answered correctly by 80-89%, and 9 questions were answered correctly by 90-100%. Questions regarding effectiveness of plasma transfusion in correcting PT (39.6%), ABO type of emergency-released RBCs (13.1%), and TA-GVHD prevention (34.6%) were answered incorrectly the most frequently (see Table). Conclusion: Formalized transfusion education for all HS must continue to be conducted. Additional instruction must be developed and deployed to improve the knowledge deficits identified by the exam. (Table Presented)
ISSN: 0041-1132
CID: 1840892

Can old dogs learn new "transfusion requirements in critical care": a survey of packed red blood cell transfusion practices among members of The American Association for the Surgery of Trauma

Sim, Vasiliy; Kao, Lillian S; Jacobson, Jessica; Frangos, Spiros; Brundage, Susan; Wilson, Chad T; Simon, Ron; Glass, Nina E; Pachter, H Leon; Todd, S Rob
BACKGROUND: The objective of this study was to characterize variations in packed red blood cell (PRBC) transfusion practices in critically ill patients and to identify which factors influence such practices. We hypothesized that significant variation in transfusion triggers exists among acute care surgeons. METHODS: A survey of PRBC transfusion practices was administered to the American Association for the Surgery of Trauma members. The scenarios examined hemoglobin thresholds for which participants would transfuse PRBCs. RESULTS: A hemoglobin threshold of less than or equal to 7 g/dL was adopted by 45% of respondents in gastrointestinal bleeding, 75% in penetrating trauma, 66% in sepsis, and 62% in blunt trauma. Acute care surgeons modified their transfusion trigger significantly in the majority of the modifications of these scenarios, often inappropriately so. CONCLUSIONS: This study documents continued evidence-practice gaps and wide variations in the PRBC transfusion practices of acute care surgeons. Numerous clinical factors altered such patterns despite a lack of supporting evidence (for or against).
PMID: 26025750
ISSN: 1879-1883
CID: 1656362

The Impact of a System-wide Policy Change Requiring CcEeK Antigen Matching for RBC Transfusions in Patients with Sickle Cell Disease [Meeting Abstract]

Jacobson, JL; Ford, K
ISSN: 1537-2995
CID: 1989402