Adjusted versus actual body weight dosing of 4-factor prothrombin complex concentrate in obese patients with warfarin-associated major bleeding

Smetana, Keaton S.; Ziemba, Rachel; May, Casey C.; Erdman, Michael; Matre, Edward T. Van; Jones, G. Morgan

doi:10.1007/s11239-018-1771-6

Cited by 14 publications

(9 citation statements)

References 14 publications

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“…Secondary end points observed in this analysis are consistent with previous trials and provide additional support for the safety of aPCC. Incidence of thrombotic events in this study was lower than in the previous analysis by Htet et al 22 (1% vs 5%) but similar to the rates observed by Smetana et al 5 (1% vs 2%). Neither of the aforementioned analyses reported time to initiation of VTE prophylaxis, and it is likely that institutional protocols regarding type and timing of VTE prophylaxis are widely variable.…”

Section: Discussionsupporting

confidence: 85%

“…4 This leaves a gap in the literature as to how PCC should be dosed in obese patients and if alternative dosing methods (ie, adjusted body weight) might be effective. A recent study published by Smetana et al 5 evaluated the use of nonactivated, 4-factor PCC in obese patients (body mass index [BMI] > 30 kg/m 2 ) and compared dosing on actual body weight with a 100-kg cap to adjusted body weight. 5 The investigators concluded that achievement of goal INR was significantly lower in the adjusted body weight group compared with the actual body weight group (36% vs 68%; P = 0.006), suggesting that using an adjusted body weight is less effective; however, this study did not evaluate bleeding outcomes, so it is difficult to extrapolate whether these findings were clinically significant.…”

Section: Introductionmentioning

confidence: 99%

“…A recent study published by Smetana et al 5 evaluated the use of nonactivated, 4-factor PCC in obese patients (body mass index [BMI] > 30 kg/m 2 ) and compared dosing on actual body weight with a 100-kg cap to adjusted body weight. 5 The investigators concluded that achievement of goal INR was significantly lower in the adjusted body weight group compared with the actual body weight group (36% vs 68%; P = 0.006), suggesting that using an adjusted body weight is less effective; however, this study did not evaluate bleeding outcomes, so it is difficult to extrapolate whether these findings were clinically significant. Although this study adds to the small body of literature specifically addressing PCC in obese patients, it is important to note that these findings were with nonactivated, 4-factor PCC.…”

Section: Introductionmentioning

confidence: 99%

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Impact of Obesity on Warfarin Reversal With Fixed-Dose Factor VIII Inhibitor Bypassing Activity (aPCC)

et al. 2020

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Background: Data are limited addressing anticoagulant reversal in obese patients using activated prothrombin complex concentrate (aPCC). Objective: Assess the impact of obesity on INR reversal with fixed aPCC dosing. Methods: Institutional review board–approved, retrospective cohort conducted in a large academic medical center. Patients 18 years or older who received fixed-dose aPCC for warfarin-associated hemorrhage were included. Patients who received aPCC for any other indications or who had no follow-up INR after aPCC administration were excluded. Patients with an INR of 5 or greater received 1000 units aPCC, whereas those with INR less than 5 received 500 units aPCC, per institutional protocol. Patients were stratified into obese and nonobese based on body mass index. Primary end point was INR reversal, defined as repeat INR of 1.4 or less within 4 hours following aPCC treatment, without a repeated dose. Secondary end points included percentage change in INR, proportion of patients requiring an additional dose of aPCC, bleeding complications, thrombotic complications, hospital length of stay, and in-hospital mortality. Results: 259 patients were included, of whom 83 were obese (32%). A significantly higher proportion of nonobese patients achieved an INR of 1.4 or less within 4 hours of treatment (169 [96.02%] vs 69 [83.13%]; P = 0.0004). There were no differences in any secondary end points. Conclusion and Relevance: When fixed-dose aPCC is used for warfarin reversal, obesity is associated with a significantly lower rate of INR reversal, without increased bleeding. This study adds to the limited amount of literature on aPCC dosing in obesity.

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Section: Discussionsupporting

confidence: 85%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Impact of Obesity on Warfarin Reversal With Fixed-Dose Factor VIII Inhibitor Bypassing Activity (aPCC)

et al. 2020

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“…Achievement of the target INR was lower in the adjusted weight group versus actual weight group (36% vs 68%; p = 0.006), with no differences in mortality or hospital stay, indicating 4F-PCC should be dosed according to the manufacturer’s guidelines in obese patients until further data are available. 44…”

Section: Resultsmentioning

confidence: 99%

Optimal Dosage and Administration Practices for Vitamin K Antagonist Reversal With 4-Factor Prothrombin Complex Concentrate

Rhoney

Chester

Darsey

2020

Clin Appl Thromb Hemost

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Expert consensus and international guidelines recommend urgent co-administration of vitamin K and 4-factor prothrombin complex concentrates (4F-PCCs) to rapidly reverse VKA-related bleeding. This narrative review examined real-world evidence and strategies to optimize international normalized ratio (INR) reversal, hemostasis, and outcomes in patients receiving 4F-PCC in this setting. Key determinants for success include the appropriate use of alternative dosing and administration strategies, such as fixed dosing and increased infusion speed, adherence to institutional guidelines, and removing significant institutional barriers to reduce time to treatment. In the opinion of authors, minimizing the time to treatment with 4F-PCCs is of paramount importance when treating patients with VKA-related bleeding. Practices that safely and feasibly shorten the time to administration should be included in guidelines for institutions responsible for anticoagulant care, and adhered to in centers that perform invasive procedures on patients receiving VKA therapy. Further studies are required to optimize use of 4F-PCC, particularly in relation to the ideal dosing strategy and the role of INR.

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“…Observational cohort studies appear to be the most achievable and interesting study design to pharmacists . Consequently, pharmacist‐led practice and education‐based research networks have been established and leveraged to conduct research in multiple pharmacy specialties, representing a way for pharmacists to become more involved in conducting multicenter research . The advantages of these networks are numerous and include bringing together practitioners and researchers to collaborate on practice‐related projects, facilitating collaborations that may be maintained beyond a single project, and enhancing the sample size and generalizability of findings .…”

Section: Introductionmentioning

confidence: 99%

How‐to guide for effectively performing and coordinating multicenter observational research as a clinical pharmacist

Hammond¹,

Rech

2019

J Am Coll Clin Pharm

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While single‐center research serves multiple purposes for the provision of patient care and identification of testable hypotheses, the importance of multicenter research is well established. The purpose of this “how‐to” guide is to assist pharmacists with the various steps in performing and coordinating multicenter, observational research. The steps that are reviewed include identifying a precise and appropriate research question; determining the expected final products or deliverables from the project and the timeline needed to satisfactorily achieve each step in the process toward these deliverables; establishing the research team structure and recognition of project contributions; navigating the institutional review board approval and data sharing and storage processes; collecting, cleaning, and analyzing data; evaluating additional project management considerations; avoiding and resolving pitfalls of multicenter research; and wrapping up the project. Resources are provided to encourage and support pharmacist principal investigators in their research efforts.

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Adjusted versus actual body weight dosing of 4-factor prothrombin complex concentrate in obese patients with warfarin-associated major bleeding

Cited by 14 publications

References 14 publications

Impact of Obesity on Warfarin Reversal With Fixed-Dose Factor VIII Inhibitor Bypassing Activity (aPCC)

Impact of Obesity on Warfarin Reversal With Fixed-Dose Factor VIII Inhibitor Bypassing Activity (aPCC)

Optimal Dosage and Administration Practices for Vitamin K Antagonist Reversal With 4-Factor Prothrombin Complex Concentrate

How‐to guide for effectively performing and coordinating multicenter observational research as a clinical pharmacist

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