Erratum to: Prothrombin Complex Concentrate for Major Bleeding on Factor Xa Inhibitors: A Prospective Cohort Study

Schulman, Sam; Gross, Peter L.; Ritchie, Bruce; Nahirniak, Susan; Lin, Yulia; Lieberman, Lani; Carrier, Marc; Crowther, Mark; Ghosh, Indy; Lazo‐Langner, Alejandro; Zondag, Michelle

doi:10.1055/s-0038-1675417

Cited by 54 publications

(78 citation statements)

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“…On the full-text review, 14 case series met inclusion criteria for this systematic review without exclusions. [18][19][20][21][22][23][24][25][26][27][28][29][30][31] An additional nine case series available as abstracts only were included in the sensitivity analysis only. [32][33][34][35][36][37][38][39][40] Characteristics of case series The impact factor of journals in which case series were published ranged from 0.0420 to 16.562 (median, 2.873) (online supplemental eTable 1).…”

Section: Literature Searchmentioning

confidence: 99%

Quality evaluation of case series describing four-factor prothrombin complex concentrate in oral factor Xa inhibitor-associated bleeding: a systematic review

et al. 2020

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IntroductionAs oral factor Xa (oFXa) inhibitor use has increased, so has publication of case series describing related bleeding managed with four-factor prothrombin complex concentrate (4F-PCC).ObjectiveThis review aimed to identify case series describing 4F-PCC management of oFXa inhibitor-related bleeding and appraise their methodological and reporting quality.DesignWe searched Medline and EMBASE (1 January 2011 to 31 May 2020) to identify series of ≥10 patients with oFXa inhibitor-related major bleeding given off-label 4F-PCC. Case series were evaluated using a validated tool adapted for this topic. The tool addressed patient selection, bleed/outcome ascertainment, causal/temporal association and reporting.ResultsWe identified 14 case series. None had ≥100 patients (range=13–84), three were prospective, two detailed appropriate inclusion criteria and four noted consecutive inclusion. While 12 series provided clear/appropriate methods for diagnosis of intracranial haemorrhage (ICH); none did so for extracranial bleeds and it was not clear whether bleeding was adjudicated in any. Haemostatic effectiveness, thrombosis and mortality were together evaluated in 12 series, but only seven used validated methods to evaluate/diagnosis haemostasis in ICH, six in gastrointestinal bleeds, five in other bleeds and three in thrombosis. Independent adjudication of haemostasis (n=1) and thrombosis (n=2) was infrequent. Thirty-day follow-up for mortality and thrombosis was noted in five and seven series. Anticoagulation measurement/levels in at least some patients were conveyed in three series. Few series provided data on anticoagulant agent/dose (n=4), time from anticoagulant (n=4), time-to-reversal (n=7), baseline (n=7) or change (n=0) in neurologic function.ConclusionsAlthough many case series describe off-label use of 4F-PCC for oFXa inhibitor-related bleeding, methodological flaws and/or poor reporting necessitates caution in interpretation.

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Section: Literature Searchmentioning

confidence: 99%

Quality evaluation of case series describing four-factor prothrombin complex concentrate in oral factor Xa inhibitor-associated bleeding: a systematic review

et al. 2020

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“…Several studies have demonstrated good hemostatic efficacy and safety outcomes of PCC in treating apixaban-and rivaroxaban-associated major bleedings. [5][6][7][8][9][10][11] This analysis is a retrospective review conducted at a single health system. Fifty-nine charts were reviewed, and 48 were included in the efficacy and safety analysis.…”

Section: Discussionmentioning

confidence: 99%

“…14 Previous studies by Majeed et al and Schulman et al in which PCC was also used for major bleeding in patients on fXa inhibitors, demonstrated similar efficacy results of 73% and 69%, respectively. 5,6 In addition, more recent retrospective analyses 14…”

Section: Discussionmentioning

confidence: 99%

“…4 Several studies have revealed 65 -93% hemostatic efficacy in varying dosing schemes of 4F-PCC in managing fXa inhibitors-related bleeds. [5][6][7][8][9][10][11] The efficacy and safety data of andexanet alfa in clinical practice are insufficient, and the available trials comparing AA versus 4F-PCC in patients with an apixaban-or rivaroxabanrelated bleeds show mixed results. In a retrospective review comparing AA versus 4F-PCC in adult patients with fXarelated ICH, Barra and colleagues reports 88.9% of good or excellent hemostatis in AA group versus 60% of that in 4F-PCC.…”

Section: Introductionmentioning

confidence: 99%

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A Retrospective Review of Four-Factor Prothrombin Complex Concentrate for Factor Xa Inhibitor-Related Bleedings

Hitchcock

Smith

et al. 2021

Journal of Pharmacy Practice

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Background: The use of factor Xa inhibitors has grown in popularity; however, the risk of major bleeding events requires for the appropriate reversal agent. The recent approved agent for factor Xa inhibitor reversal, andexanet alfa, has limited clinical efficacy and safety data, and it can be a financial burden on healthcare systems due to its high cost. Four-factor prothrombin complex concentrate (4F-PCC) has been utilized off label in patients with factor Xa inhibitor-related bleedings. Objective: The aim of this study was to assess the safety and efficacy of 4F-PCC in managing factor Xa inhibitor-related bleedings. Methods: This is an observational, retrospective review of 4F-PCC usage in treating factor Xa inhibitor-related bleeds from May 2014 to December 2018 at a single health system. Efficacy was evaluated using the assessment criteria described by Sarode et al. Secondary outcomes analyzed included thromboembolic events, length of stay, mortality, and discharge disposition. Results: Fifty-nine patient charts were reviewed, and 48 patients were included in the study analysis. The administration of 4F-PCC achieved effective hemostasis in 33 patients (68%), and effective hemostasis was achieved in 12 patients (86%) who had intracranial hemorrhage and did not receive any surgical intervention. Thromboembolic events occurred in 4 patients within 30 days from 4F-PCC use. A majority of patients (85.4%) were discharged from the hospital to home or long-term care; 7 patients (14.6%) expired in the hospital. Conclusion: Efficacy was achieved in over half of the patient population in this cohort who received 4F-PCC for factor Xa inhibitor-related bleeding events.

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“…PCC can effectively restore haemostasis in patients requiring urgent treatment of bleeding related to DOACs as was shown in multiple clinical studies. The UPRATE study investigated the effectiveness of 4F-PCC to treat bleeding associated with FXa inhibitors in two cohorts (Sweden and Canada) and showed comparable haemostatic effectiveness in both groups (69% and 68% of patients, respectively); the authors suggested that 4F-PCC could become an effective and relatively affordable option for management of DOAC-associated bleeding [ 61 , 62 ]. Furthermore, a retrospective study of 4F-PCC in patients with major bleeding and a need for treatment of FXa inhibitor-associated bleeding reported excellent or good haemostasis in 89% of cases [ 63 ].…”

Section: Bleeding In Patients On Oral Anticoagulantsmentioning

confidence: 99%

Management of Coagulopathy in Bleeding Patients

Hofer

Schlimp

Casu

et al. 2021

JCM

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Early recognition of coagulopathy is necessary for its prompt correction and successful management. Novel approaches, such as point-of-care testing (POC) and administration of coagulation factor concentrates (CFCs), aim to tailor the haemostatic therapy to each patient and thus reduce the risks of over- or under-transfusion. CFCs are an effective alternative to ratio-based transfusion therapies for the correction of different types of coagulopathies. In case of major bleeding or urgent surgery in patients treated with vitamin K antagonist anticoagulants, prothrombin complex concentrate (PCC) can effectively reverse the effects of the anticoagulant drug. Evidence for PCC effectiveness in the treatment of direct oral anticoagulants-associated bleeding is also increasing and PCC is recommended in guidelines as an alternative to specific reversal agents. In trauma-induced coagulopathy, fibrinogen concentrate is the preferred first-line treatment for hypofibrinogenaemia. Goal-directed coagulation management algorithms based on POC results provide guidance on how to adjust the treatment to the needs of the patient. When POC is not available, concentrate-based management can be guided by other parameters, such as blood gas analysis, thus providing an important alternative. Overall, tailored haemostatic therapies offer a more targeted approach to increase the concentration of coagulation factors in bleeding patients than traditional transfusion protocols.

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Erratum to: Prothrombin Complex Concentrate for Major Bleeding on Factor Xa Inhibitors: A Prospective Cohort Study

Cited by 54 publications

References 0 publications

Quality evaluation of case series describing four-factor prothrombin complex concentrate in oral factor Xa inhibitor-associated bleeding: a systematic review

Quality evaluation of case series describing four-factor prothrombin complex concentrate in oral factor Xa inhibitor-associated bleeding: a systematic review

A Retrospective Review of Four-Factor Prothrombin Complex Concentrate for Factor Xa Inhibitor-Related Bleedings

Management of Coagulopathy in Bleeding Patients

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