Four-factor prothrombin complex concentrate improves thrombin generation and prothrombin time in patients with bleeding complications related to rivaroxaban: a single-center pilot trial

Schenk, Bettina; Goerke, Stephanie; Beer, Ronny; Helbok, Raimund; Fries, Dietmar; Bachler, Mirjam

doi:10.1186/s12959-017-0158-9

Cited by 27 publications

(24 citation statements)

References 21 publications

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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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“…We present a small subgroup of patients with DOAC‐related bleeding, which was controlled in 78·8% and showed INR normalisation in 66·7%. Some studies report that PCC can swiftly and effectively be used in patients receiving anti‐Xa inhibitors (Schenk et al, ).…”

Section: Discussionmentioning

confidence: 99%

Safety and effectiveness of a prothrombin complex concentrate in approved and off‐label indications

Marcos-Jubilar

García-Erce

Martínez‐Calle

et al. 2019

Transfusion Medicine

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Objective: To evaluate the effectiveness and safety of prothrombin complex concentrates (PCCs) in approved and off-label indications.Background: PCCs are approved for the urgent reversal of vitamin K antagonists (VKAs). Data concerning the efficacy, safety and dosing for off-label indications are limited, but they are included in massive bleeding protocols. Methods:This was a retrospective review of cases treated with four-factor PCCs (4F-PCCs) between January 2009 and 2016. Efficacy end-points include: (i) VKA reversal efficacy assessed by international normalised ratio (INR) normalisation (<1·5) and (ii) clinical efficacy as bleeding cessation and/or decreased number of transfused blood components and 24-h mortality in bleeding coagulopathy. The safety end-point is the incidence of thromboembolic events. Results:A total of 328 patients were included (51·8% male, median age 78 years old). Indications were as follows: VKA reversal (66·6%), bleeding coagulopathy (30·5%) and direct anticoagulant (DOAC) reversal due to bleeding (2·5%). VKA reversal was effective in 97·1% of patients, and 76·5% demonstrated complete reversal (INR < 1·5); only 34·3% patients needed hemoderivatives. Prior to emergency procedures, PCCs achieved global responses in 83% of patients, with no bleeding complication during intervention. DOAC reversal was effective in 88·9% of patients. Bleeding cessation was associated with the dose administered (P = 0·002). In coagulopathy bleeding, haemorrhage cessation, established by the International Society of Thrombosis and Haemostais (ISTH) definition, occurred in 56·7% of massive bleeding events and in 42·5% of The administration of prothrombin complex concentrates is useful in approved and off-label indications for life-threatening bleeding and should be incorporated in massive bleeding protocols. other coagulopathies; 24-h mortality was 30%, mainly related to active bleeding. Ten thrombotic episodes were observed (3·1%).Conclusion: 4F-PCC was effective as adjuvant treatment with an acceptable safety profile, not only for the emergent reversal of VKAs but also for refractory coagulopathy associated with major bleeding.

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“…Still, its risks should be kept in mind, because PCC is known to generate substantial amounts of thrombin, which may be associated with an increased risk of thromboembolic complications. 84…”

Section: Platelet Concentratementioning

confidence: 99%

Optimizing Perioperative Blood and Coagulation Management During Cardiac Surgery

Meesters

Heymann

2019

Anesthesiology Clinics

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Major blood loss remains common in cardiac surgery with an incidence of up to 15%. 1,2 Bleeding leads to anemia and blood product transfusion, and can lead to the need for rethoracotomy, which are all independently associated with an adverse outcome (Fig. 1). 3,4 Patient blood management is the bundle of measures to Disclosure Statement: M.I. Meesters does not have any disclosures. C. von Heymann discloses that he has received honoraria for lectures and consultancy work, travel reimbursements and research grants related to the topic of this article from CSL Behring, Novo Nordisk, Ferring GmbH, and Shire over the last 3 years.

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Four-factor prothrombin complex concentrate improves thrombin generation and prothrombin time in patients with bleeding complications related to rivaroxaban: a single-center pilot trial

Cited by 27 publications

References 21 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

Safety and effectiveness of a prothrombin complex concentrate in approved and off‐label indications

Optimizing Perioperative Blood and Coagulation Management During Cardiac Surgery

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