Correction of INR by prothrombin complex concentrate and vitamin K in patients with warfarin related hemorrhagic complication

Yasaka, Masahiro; Sakata, Toshiyuki; Minematsu, Kazuo; Naritomi, Hiroaki

doi:10.1016/s0049-3848(02)00402-4

Cited by 151 publications

(92 citation statements)

References 21 publications

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“…In a chart review study of 17 patients presenting with hemorrhagic complications (15 with ICH), vitamin K monotherapy was less effective for rapid INR reversal than PCC with or without concomitant vitamin K. 63 Vitamin K monotherapy may be considered in certain clinical scenarios, such as in patients with left ventricular assist devices, where continuous anticoagulation is required. However, if more rapid INR reduction is required, as is very often the case, coadministration of PCC and vitamin K would be more appropriate.…”

Section: Safetymentioning

confidence: 99%

“…42,62, 63 The largest of these studies compared outcomes in 50 patients treated with (n=22) or without (n=28) PCC. 42 Rapid INR reversal with PCC was more effective in preventing hematoma expansion, poor outcomes and in-hospital mortality, with lower rates for each outcome observed in those treated with PCC vs. control (P=0.017, P=0.045 and P=0.042, respectively).…”

Section: Treatment Of Vka-associated Ich In Japanmentioning

confidence: 99%

“…No TEEs occurred in 2 of the Japanese studies that reported safety outcomes. 62, 63 In a prospective, observational cohort analysis of treatment regimens for warfarin reversal in patients with ICH, 3/11 TEEs occurred in patients treated with PCC. 64 In 1 case, the TEE occurred >90 days after the ICH and the patient had been re-anticoagulated; VKA therapy had not been resumed in the other 2 patients at the time of the TEE.…”

Section: Treatment Of Vka-associated Ich In Japanmentioning

confidence: 99%

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Prothrombin Complex Concentrate for Vitamin K Antagonist-Associated Intracranial Hemorrhage　― Global Evidence and the Japanese Perspective ―

Yasaka

Brainsky

Toyoda

2017

Circ J

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Patients receiving vitamin K antagonists (VKAs) are at increased risk of bleeding. Intracranial hemorrhage (ICH) is a major cause of morbidity and mortality in this population, and is a particular concern among Japanese clinicians, given reports of an elevated risk of this bleeding type in patients of Asian ethnicity. Patients with VKA-associated ICH require rapid international normalized ratio (INR) reversal, and treatment guidelines suggest the use of prothrombin complex concentrates (PCCs) or plasma for this purpose. Although European and US guidelines recommend PCCs for the treatment of VKA-associated major bleeding, they do not make a specific recommendation in the setting of ICH, owing to the lack of comparative evidence. In contrast, Japanese guidelines recommend the use of PCCs rather than plasma for VKA reversal in patients with ICH; however, these agents are not currently licensed in Japan for this indication. Here we review the available evidence on the use of PCCs for the treatment of VKA-associated ICH, both globally and specifically in Japanese settings. Overall, the evidence reviewed here supports the use of PCC for rapid VKA reversal in these patients.

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Section: Safetymentioning

confidence: 99%

Section: Treatment Of Vka-associated Ich In Japanmentioning

confidence: 99%

Section: Treatment Of Vka-associated Ich In Japanmentioning

confidence: 99%

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Prothrombin Complex Concentrate for Vitamin K Antagonist-Associated Intracranial Hemorrhage　― Global Evidence and the Japanese Perspective ―

Yasaka

Brainsky

Toyoda

2017

Circ J

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“…Failure to administer vitamin K may cause the INR to rise, usually 12 to 24 hours after initial treatment because the half-life of warfarin far exceeds the half-life of the administered coagulation factor complexes. 54 Recombinant FVIIa (rFVIIa) has been used in patients with acute intracerebral hemorrhage who were not receiving anticoagulant therapy. 55,56 Although earlier results were promising, 55 a larger randomized trial failed to confirm rFVIIa reduced mortality.…”

Section: Management Of Patients Who Require Urgent Reversal Of Anticomentioning

confidence: 99%

Management of Excessive Anticoagulant Effect Due to Vitamin K Antagonists

Dentali

Crowther²

2008

Hematology

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Coagulation factor replacement is required given the need to urgently correct the INR; however, vitamin K should not be forgotten since it is required to antagonize the effect of warfarin, preventing "rebound" anticoagulation after transfused coagulation factors are consumed. This paper will review the evidence supporting various treatment modalities and will provide suggestions for treatment. Future advances in this area will likely focus on evaluations of the relative merits of FFP and PCCs.

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“…In contrast, the lower volumes of PCC can generally be administered within 10 to 60 min [16][17][18][19][20][21][22][23][24][25][26][27]. Consequently, international normalized ratio (INR) can be very rapidly decreased with PCC, and critical time can be saved under emergency circumstances [24].…”

Section: Introductionmentioning

confidence: 99%

Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate

et al. 2009

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Prothrombin complex concentrate (PCC) infusion is preferred for emergency reversal of coumarin therapy. Rapid infusion can potentially save crucial time; however, the possible impact of high infusion speed on PCC safety and effectiveness has not been delineated. In a prospective multinational clinical trial with 43 patients receiving PCC (Beriplex® P/N) for emergency reversal of coumarin therapy, infusion speeds were selected by the investigators. In a twophase statistical analysis, the influence of baseline patient variables and dose on selected infusion speed was assessed. Then, the effect of infusion speed on reduction in international normalized ratio (INR) and on thrombogenicity marker pharmacokinetics was evaluated. Infusion speed ranged widely from 2.0 to 40.0 mL min −1 with a median of 7.5 mL min −1 . Selection of infusion speed was not significantly influenced by gender, age, body mass index, presence of acute bleeding, indication for coumarin therapy, baseline INR, or PCC dose. Infusion speed was higher by a median of 2.2 mL min −1 (95% confidence interval, 1.0-4.3 mL min −1 ) among patients receiving Beriplex P/N volumes ≥80 mL compared with smaller infusion volumes. Infusion speed did not affect INR attained 30 min following PCC infusion. None of the evaluated thrombogenicity marker pharmacokinetic parameters was affected by infusion speed. Infusions in one patient with questionable hemostatic efficacy and another with a possibly PCC-related thromboembolic event were at moderate and slow speeds, respectively. This study provides the first direct evidence that Beriplex® P/N can be rapidly infused for emergency coumarin therapy reversal without altering safety or effectiveness.

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Correction of INR by prothrombin complex concentrate and vitamin K in patients with warfarin related hemorrhagic complication

Cited by 151 publications

References 21 publications

Prothrombin Complex Concentrate for Vitamin K Antagonist-Associated Intracranial Hemorrhage　― Global Evidence and the Japanese Perspective ―

Prothrombin Complex Concentrate for Vitamin K Antagonist-Associated Intracranial Hemorrhage　― Global Evidence and the Japanese Perspective ―

Management of Excessive Anticoagulant Effect Due to Vitamin K Antagonists

Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate

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Correction of INR by prothrombin complex concentrate and vitamin K in patients with warfarin related hemorrhagic complication

Cited by 151 publications

References 21 publications

Prothrombin Complex Concentrate for Vitamin K Antagonist-Associated Intracranial Hemorrhage ― Global Evidence and the Japanese Perspective ―

Prothrombin Complex Concentrate for Vitamin K Antagonist-Associated Intracranial Hemorrhage ― Global Evidence and the Japanese Perspective ―

Management of Excessive Anticoagulant Effect Due to Vitamin K Antagonists

Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate

Contact Info

Product

Resources

About

Prothrombin Complex Concentrate for Vitamin K Antagonist-Associated Intracranial Hemorrhage　― Global Evidence and the Japanese Perspective ―

Prothrombin Complex Concentrate for Vitamin K Antagonist-Associated Intracranial Hemorrhage　― Global Evidence and the Japanese Perspective ―