Comparison of Hemostatic Outcomes in Patients Receiving Fixed-Dose vs. Weight-Based 4-Factor Prothrombin Complex Concentrate

Use and effectiveness of a two‐level initiation strategy for fixed‐dose prothrombin complex concentrate according to the initial international normalized ratio in an emergency department in Japan

“…As we previously demonstrated, 14 an extremely low fixed dose of 500 IU is likely inadequate for successful OAT reversal in patients with moderate INR elevation (initial INR > 2.5); however, these doses (25–50 IU/kg) may be excessive in some patients, thereby increasing costs and the risk of thrombogenicity. Recent fixed‐dose PCC protocols for OAT reversal that exhibited reasonable efficacy adopted a relatively higher dose (1,500–2,000 IU) than our institutional protocol 21–23 . According to our previous results, 14 the efficacy for normalization of INR using a fixed PCC dose of 500 IU could not be confirmed in Japanese patients.…”

“…Recent fixed-dose PCC protocols for OAT reversal that exhibited reasonable efficacy adopted a relatively higher dose (1,500-2,000 IU) than our institutional protocol. [21][22][23] According to our previous results, 14 the efficacy for normalization of INR using a fixed PCC dose of 500 IU could not be confirmed in Japanese patients. In this study, we used a fixed PCC dose of 1,000 IU in patients with initial INR over 2.5 and achieved good laboratory responses.…”

Retrospective Analysis of the Real-World Utilization of 4-Factor Prothrombin Complex Concentrate and Plasma in Oral Anticoagulant-Associated Bleeding in US Hospitals

“…However, utilizing 4F-PCC may circumvent the need for extra dosing, 50 and fixed dosing of 4F-PCC instead of weight-based dosing may be more cost-effective, while still as effective at controlling bleeding and restoring hemostasis across varied clinical settings for VKA reversal. 34,51–54 Despite small cohort studies reporting hemostatic efficacy for low-dose 4F-PCC in DOAC-associated bleeding, 33 higher doses are still required within this setting. 21 Reducing blood product usage within clinical settings can alleviate the burden of supplying clinical demand that can make use of alternative, sometimes better recommended treatment options, as highlighted throughout the pandemic, 48,49 in addition to donor exposure and associated risks of blood product transfusions for the individual patient.…”

Use of Prothrombin Complex Concentrate in Oral Anticoagulant-Associated Major Bleeding

“…All of these studies are limited by their retrospective nature and small sample sizes, and vary widely in study design, doses of PCC used, population included, outcomes evaluated, and overall results. 46,[48][49][50][51][52] Based on these low-quality studies, use of low-dose PCC may be a viable option for factor Xa inhibitor reversal and may be particularly useful as a future cost-saving measure or in cases where supply of PCC is limited. There remains a substantial need for prospective, randomized trials to evaluate what the ideal dose of PCC for factor Xa inhibitor-related bleeding is.…”

“…This has led to the emergence of studies evaluating lower dosing regimens for factor Xa inhibitor reversal. All of these studies are limited by their retrospective nature and small sample sizes, and vary widely in study design, doses of PCC used, population included, outcomes evaluated, and overall results 46,48–52. Based on these low-quality studies, use of low-dose PCC may be a viable option for factor Xa inhibitor reversal and may be particularly useful as a future cost-saving measure or in cases where supply of PCC is limited.…”