Audit of warfarin reversal using a new Octaplex reduced dose protocol

Hirri, H. M.; Green, P.J.

doi:10.1016/j.transci.2014.08.024

Cited by 12 publications

(6 citation statements)

References 9 publications

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“…However, adherence to the protocol was poor, as the medical team did not regularly consult it in emergency situations (the protocol was followed exactly in only 40.2% of patients). 41…”

Section: Resultsmentioning

confidence: 99%

“…40 Alternative dosing algorithms have been proposed, including regimens based on bodyweight alone, or the indication for administration. 41 Indeed, an audit of warfarin reversal assessing a 3-level dosing protocol (2000 IU for CNS bleeds, 1500 IU for other bleeds and 1000 IU prior to invasive procedures) found the INR was reversed to 1.5 in 84% (56/67) of patients, suggesting a simple protocol can be effective. However, adherence to the protocol was poor, as the medical team did not regularly consult it in emergency situations (the protocol was followed exactly in only 40.2% of patients).…”

Section: Alternative Dosing Strategiesmentioning

confidence: 99%

“…However, adherence to the protocol was poor, as the medical team did not regularly consult it in emergency situations (the protocol was followed exactly in only 40.2% of patients). 41 A thrombin generation assay (TGA)-based calculation is an experimental approach to monitoring VKA treatment, bleeding risk, and 4F-PCC reversal of VKA-related bleeding. TGA-based calculations may be superior to INR-based calculations (based on the linear relationship between hemorrhagepredictive TGA parameters and 4F-PCC dose for the whole therapeutic range versus the exponential relationship demonstrated for INR and dose).…”

Section: Alternative Dosing Strategiesmentioning

confidence: 99%

See 2 more Smart Citations

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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“…However, adherence to the protocol was poor, as the medical team did not regularly consult it in emergency situations (the protocol was followed exactly in only 40.2% of patients). 41…”

Section: Resultsmentioning

confidence: 99%

Section: Alternative Dosing Strategiesmentioning

confidence: 99%

Section: Alternative Dosing Strategiesmentioning

confidence: 99%

See 1 more Smart Citation

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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“…Based on the findings from this trial and local audits, a prospective, observational study was conducted in 67 patients assessing the use of a protocol for fixed‐dose 4F‐PCC (Octaplex) based on indication for VKA reversal, with patients receiving 2000 IU for ICH, 1500 IU for ECH, and 1000 IU for invasive procedures . However, the protocol was adhered to in only 40% of patients, with 24% receiving a larger dose and 36% receiving a smaller dose than indicated per protocol.…”

Section: ‐Iu Fixed‐dose Protocolsmentioning

confidence: 99%

Fixed‐Dose Four‐Factor Prothrombin Complex Concentrate for Vitamin K Antagonist Reversal: Does One Dose Fit All?

2019

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Four-factor prothrombin complex concentrate (4F-PCC) has emerged as the preferred option for emergent reversal of vitamin K antagonists (VKAs); however, the optimal dosing strategy is unknown.Although several studies have attempted to determine the optimal dose of 4F-PCC using a variety of dosing regimens, no dosing strategy has been found to be superior. Many of these studies have evaluated a low, fixed dose of 4F-PCC rather than individualized dosing as recommended in product labeling. The purpose of this review was to evaluate the efficacy and safety of various fixed-dose strategies of 4F-PCC for emergent VKA reversal and to assess limitations of the existing literature. A search of the PubMed database was performed from the earliest available date through 2018 for relevant articles describing fixed-dose 4F-PCC for VKA reversal. Reference lists of relevant articles were also manually reviewed. Most currently available studies are primarily observational and heterogeneous in design. A very low fixed dose of 500 IU is likely inadequate for successful VKA reversal, but increased fixed doses of 1000-1500 IU have found some degree of success and may be considered for VKA reversal. However, many of these studies consistently identified a trend toward international normalized ratio (INR) reversal failure in patients presenting with high baseline INR values or intracranial hemorrhage, suggesting that higher 4F-PCC doses are needed in these patients. Available studies are underpowered to determine whether a dose-dependent association with thrombotic risk exists. Additional large, randomized studies are needed to determine the optimal dosing strategy and ascertain the role for fixed-dose 4F-PCC. KEY WORDS prothrombin complex concentrates, warfarin, hemorrhage, hemostasis.

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“…38 Several studies demonstrated fixed doses of 1,000, 1,500, or 2,000 units to be effective at INR correction. [39][40][41][42][43] However, a recent study in patients with intracranial bleeding demonstrated a fixed dosing strategy of 1,000 units was not as effective as variable dosing in achieving an INR 1.5. 44 Fixed weight-based doses of 25 and 30 units/kg have also been reported with effective INR correction.…”

Section: Phytonadione (Vitamin K1)mentioning

confidence: 99%

Reversal of Oral Anticoagulants for Intracerebral Hemorrhage Patients: Best Strategies

Fuh

Sin

Goldstein

et al. 2017

Semin Respir Crit Care Med

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In patients with acute intracerebral hemorrhage (ICH), one of the major concerns is ongoing bleeding or ICH expansion. Anticoagulated patients are at higher risk of ongoing expansion and worse outcome. It may be that rapid anticoagulation reversal can reduce the risk of expansion and improve clinical outcome. For those taking coumarins, the best available evidence suggests that intravenous vitamin K combined with four-factor prothrombin complex concentrate (4F-PCC) is the most rapid and effective regimen to restore hemostasis. For those on dabigatran, the highest quality data available for reversal are for idarucizumab, although it is not yet clear whether patients derive clinical benefit from this reversal. In the absence or failure of idarucizumab, activated prothrombin complex concentrate (aPCC) is recommended. For those on factor Xa inhibitors, the ideal reversal agent is not clear. Many providers use 4F-PCC or aPCC, but more specific agents are in clinical trials and may soon be available. In addition, the half-lives of the non-vitamin K antagonists are relatively short compared with warfarin, and so some patients may not have a clinically relevant coagulopathy at the time of presentation. Overall, the optimal reversal agent, when one is required, is a function of which anticoagulant the patient is taking.

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Audit of warfarin reversal using a new Octaplex reduced dose protocol

Cited by 12 publications

References 9 publications

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

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

Fixed‐Dose Four‐Factor Prothrombin Complex Concentrate for Vitamin K Antagonist Reversal: Does One Dose Fit All?

Reversal of Oral Anticoagulants for Intracerebral Hemorrhage Patients: Best Strategies

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