The Role of FEIBA in Reversing Novel Oral Anticoagulants in Intracerebral Hemorrhage

Dibu, Jamil; Weimer, Jonathan M.; Ahrens, Christine; Manno, Edward M.; Frontera, Jennifer A.

doi:10.1007/s12028-015-0213-y

Cited by 59 publications

(47 citation statements)

References 29 publications

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“…17 Case reports of using FFP or PCC to treat excess rivaroxaban ingestion have shown modest success in improving laboratory coagulation parameters. 18–20 However, the correction of coagulation tests by PCC, FFP, or recombinant factor VII activated does not imply the reversal of the clinical anticoagulation effect of the drug. There is no evidence that FFP or PCC controls NOAC-associated bleeding in humans.…”

Section: Noac Reversalmentioning

confidence: 99%

Management of Patients on Non–Vitamin K Antagonist Oral Anticoagulants in the Acute Care and Periprocedural Setting: A Scientific Statement From the American Heart Association

Raval¹,

Cigarroa²,

Chung³

et al. 2017

Circulation

224

147

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Non–vitamin K oral anticoagulants (NOACs) are now widely used as alternatives to warfarin for stroke prevention in atrial fibrillation and management of venous thromboembolism. In clinical practice, there is still widespread uncertainty on how to manage patients on NOACs who bleed or who are at risk for bleeding. Clinical trial data related to NOAC reversal for bleeding and perioperative management are sparse, and recommendations are largely derived from expert opinion. Knowledge of time of last ingestion of the NOAC and renal function is critical to managing these patients given that laboratory measurement is challenging because of the lack of commercially available assays in the United States. Idarucizumab is available as an antidote to rapidly reverse the effects of dabigatran. At present, there is no specific antidote available in the United States for the oral factor Xa inhibitors. Prothrombin concentrate may be considered in life-threatening bleeding. Healthcare institutions should adopt a NOAC reversal and perioperative management protocol developed with multidisciplinary input.

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Section: Noac Reversalmentioning

confidence: 99%

Management of Patients on Non–Vitamin K Antagonist Oral Anticoagulants in the Acute Care and Periprocedural Setting: A Scientific Statement From the American Heart Association

Raval¹,

Cigarroa²,

Chung³

et al. 2017

Circulation

224

147

View full text Add to dashboard Cite

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“…64 In one case report of parietal CNS bleeding (20 cm 3 ) in a patient receiving dabigatran, a FEIBA dose of 50 IU/kg administered 12 hours after the last dabigatran dose and 8 hours from ICH onset prevented expansion of the hematoma without any related complications. 67 In one case of massive cardiac bleeding due to septal perforation during an ablation attempt, low-dose FEIBA (26 IU/ kg) was noted to stop the bleeding by the end of the 15-minute infusion. 63 Observation from the pericardial window noted a substantial slowing of the bleeding after approximately 8 IU/kg of FEIBA had been infused, suggesting that lower doses may be effective, which is consistent with suggestions by Marlu et al 47 Furthermore, there was no evidence of a thrombotic event in this patient.…”

Section: S19mentioning

confidence: 99%

“…This patient had elevated rivaroxaban levels and was given an additional 25 IU/kg of aPCC as a precautionary measure. 67 In another single-center retrospective analysis, 18 patients with ICH taking either rivaroxaban (n = 16) or apixaban (n = 2) received PCC4 (Kcentra) at doses of 2124-4770 IU (mean dose, 3177 IU). Favorable outcomes at 90 days were noted in 6 of the 18 patients, with only 1 demonstrating bleeding progression on repeat computerized tomography.…”

Section: 69mentioning

confidence: 99%

Current knowledge on assessing the effects of and managing bleeding and urgent procedures with direct oral anticoagulants

Dager

Hellwig

2016

American Journal of Health-System Pharmacy

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purpose. Current knowledge on managing major bleeding events with available hemostatic agents, including their combined use with potential reversal agents, in patients taking direct oral anticoagulant (DoaCs) is reviewed.Summary. over the past five years, a new generation of oral agents, the DoaCs, has emerged as commonly used anticoagulants for stroke prevention in non-valvular atrial fibrillation, and treatment or secondary prevention of venous thromboembolism. management of a bleeding event in the setting of DoaC therapy should take into account the relative risks of bleeding and thrombosis, which will determine the degree of anticoagulant reversal required. In the setting of a major (critical) bleeding event associated with notable blood loss, management may include transfusions of blood products to sustain the function of organ systems, and the availability of specific reversal agents will provide additional options for bleeding management. beyond withholding the DoaC and providing supportive management that addresses any factors contributing to the bleeding event, clinicians may desire to expedite the removal of any anticoagulation effects. In general, this is accomplished by either removing or neutralizing the anticoagulant or by independently establishing hemostasis. Conclusion.With or without reversal agents, patients may require supportive management such as mechanical pressure, volume support, transfusions of blood products, and, depending on the situation, surgery to repair the bleeding source. specific reversal agents are currently under development or have recently been approved for the urgent management of bleeding events or the facilitation of invasive procedures in patients receiving DoaCs.Am J Health-Syst Pharm. 2016; 73(suppl 2):s14-26

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“…There are, however, several case reports where aPCC has been administrated to patients on DOACs, and in these cases an increased risk of thromboembolism was not observed. In the reported cases aPCC (FEIBA) in doses of 30‐55 IU/kg was administrated to patients on DOACs with intracranial bleeding or abdominal aneurysm where immediate surgery was needed …”

Section: Discussionmentioning

confidence: 99%

The reversal effect of prothrombin complex concentrate (PCC), activated PCC and recombinant activated factor VII in apixaban‐treated patients in vitro

Schultz

Tran

Bjørnsen

et al. 2017

Research and Practice in Thrombosis and Haemostasis

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Essentials An antidote for apixaban is not yet available.We tested the effect of different haemostatic agents to reverse the apixaban effect in vitro.Activated prothrombin complex concentrate (aPCC) was superior to prothrombin complex concentrate and recombinant activated factor VII.Even low doses of aPCC reversed the apixaban effect completely in vitro. BackgroundThe number of patients under treatment with FXa inhibitors is increasing, but there is no concensus on how to reverse their anticoagulant effect in case of a life‐threatening bleeding. A specific antidote is not yet commercially available. Prothrombin complex concentrate (PCC), activated PCC (aPCC) and recombinant factor VIIa (rFVIIa) are suggested available reversal agents.ObjectivesTo find the most effective reversal agent to apixaban and to determine the optimal dose.Patients/Methods PCC, aPCC, and rFVIIa at concentrations imitating 80%, 100%, and 125% of suggested therapeutic doses were added to blood drawn from apixaban‐treated patients (n=30). aPCC was also tested in a 50% dose. Samples from healthy subjects (n=40) were used as controls. Thromboelastometry in whole blood (WB) and thrombin generation in platelet‐poor plasma (PPP) were measured to assess the reversal effect.Results aPCC shortened clotting time (CT) in WB, and increased the peak thrombin concentration and velocity index in PPP to a greater extent than PCC and rFVIIa. No significant differences were seen between rFVIIa and aPCC on thrombin generation lag time, or between PCC and aPCC on endogenous thrombin potential (ETP). The 50% dose of aPCC had a slightly inferior effect, but was comparable to the other reversal agents.ConclusionsIn this in vitro study the 80% dose of aPCC (40 IU/kg) reversed the anticoagulant effect of apixaban more effectively than the corresponding dose of rFVIIa and PCC both in WB (CT) and PPP (peak, ETP).

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The Role of FEIBA in Reversing Novel Oral Anticoagulants in Intracerebral Hemorrhage

Abstract: In this small case series, reversal of NOAC with FEIBA was not associated with ICH expansion or any thrombotic or hemorrhagic complications.

Cited by 59 publications

References 29 publications

Management of Patients on Non–Vitamin K Antagonist Oral Anticoagulants in the Acute Care and Periprocedural Setting: A Scientific Statement From the American Heart Association

Management of Patients on Non–Vitamin K Antagonist Oral Anticoagulants in the Acute Care and Periprocedural Setting: A Scientific Statement From the American Heart Association

Current knowledge on assessing the effects of and managing bleeding and urgent procedures with direct oral anticoagulants

The reversal effect of prothrombin complex concentrate (PCC), activated PCC and recombinant activated factor VII in apixaban‐treated patients in vitro

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