Rapid warfarin reversal

A 3-factor prothrombin complex concentrate and recombinant factor VIIa cocktail for intracerebral hemorrhage: Clinical article

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Abstract

Object. Intracerebral hemorrhage (ICH) is the most serious bleeding complication of vitamin K antagonist (VKA) therapy, carrying a high mortality. Rapid reversal of VKA in ICH is critical. Plasma therapy, the standard of care in the US, is not optimal. The ideal prothrombin complex concentrate (PCC) containing all vitamin K-dependent factors (VKDFs) is not available in the US. Therefore, the authors developed a Trauma Coumadin Protocol (TCP) consisting of a 3-factor PCC available in the US (which contains insufficient factor VII [FVII]) with a low-dose recombinant FVIIa to rapidly reverse VKA. Methods. Forty-six patients treated with the TCP were retrospectively analyzed. Fourteen patients had pre- and post-TCP plasma samples collected to assess their VKDF increment. Eleven patients had measurable intraparenchymal hematomas, which were evaluated for expansion. Results. The mean pre- and post-TCP international normalized ratios (INRs) were 3.4 (median 2.9) and 1.0 (median 0.9), respectively. Once corrected, INR was maintained at < 1.3 during a patient's hospital stay. The pre-TCP median values of FII, FVII, FIX, and FX were 28%, 21%, 45%, and 20%, respectively; post-TCP median values increased to 144%, 417%, 102%, and 143%, respectively. Four of the 11 patients with measurable intraparenchymal hemorrhage had expansion at 24 hours after TCP. One patient probably (8 hours post-TCP) and 1 patient possibly (3 days post-TCP) had thrombotic complications. Conclusions. The TCP was very effective in rapidly reversing VKA-associated coagulopathy; however, this protocol should be used cautiously in patients at high risk for thrombosis.

Original languageEnglish (US)
Pages (from-to)491-497
Number of pages7
JournalJournal of Neurosurgery
Volume116
Issue number3
DOIs
StatePublished - Mar 2012

Fingerprint

Cerebral Hemorrhage
Warfarin
Vitamin K
Wounds and Injuries
Factor VII
International Normalized Ratio
recombinant FVIIa
prothrombin complex concentrates
Hemorrhage
Standard of Care
Hematoma
Length of Stay
Thrombosis
Mortality

Keywords

  • Concentrate
  • Fresh-frozen plasma
  • International normalized ratio
  • Intracerebral hemorrhage
  • Prothrombin complex
  • Vitamin k
  • Warfarin

ASJC Scopus subject areas

  • Clinical Neurology
  • Surgery

Cite this

@article{375318a7da2d4e90925c9dda46ec2ffe,
title = "Rapid warfarin reversal: A 3-factor prothrombin complex concentrate and recombinant factor VIIa cocktail for intracerebral hemorrhage: Clinical article",
abstract = "Object. Intracerebral hemorrhage (ICH) is the most serious bleeding complication of vitamin K antagonist (VKA) therapy, carrying a high mortality. Rapid reversal of VKA in ICH is critical. Plasma therapy, the standard of care in the US, is not optimal. The ideal prothrombin complex concentrate (PCC) containing all vitamin K-dependent factors (VKDFs) is not available in the US. Therefore, the authors developed a Trauma Coumadin Protocol (TCP) consisting of a 3-factor PCC available in the US (which contains insufficient factor VII [FVII]) with a low-dose recombinant FVIIa to rapidly reverse VKA. Methods. Forty-six patients treated with the TCP were retrospectively analyzed. Fourteen patients had pre- and post-TCP plasma samples collected to assess their VKDF increment. Eleven patients had measurable intraparenchymal hematomas, which were evaluated for expansion. Results. The mean pre- and post-TCP international normalized ratios (INRs) were 3.4 (median 2.9) and 1.0 (median 0.9), respectively. Once corrected, INR was maintained at < 1.3 during a patient's hospital stay. The pre-TCP median values of FII, FVII, FIX, and FX were 28{\%}, 21{\%}, 45{\%}, and 20{\%}, respectively; post-TCP median values increased to 144{\%}, 417{\%}, 102{\%}, and 143{\%}, respectively. Four of the 11 patients with measurable intraparenchymal hemorrhage had expansion at 24 hours after TCP. One patient probably (8 hours post-TCP) and 1 patient possibly (3 days post-TCP) had thrombotic complications. Conclusions. The TCP was very effective in rapidly reversing VKA-associated coagulopathy; however, this protocol should be used cautiously in patients at high risk for thrombosis.",
keywords = "Concentrate, Fresh-frozen plasma, International normalized ratio, Intracerebral hemorrhage, Prothrombin complex, Vitamin k, Warfarin",
author = "Ravi Sarode and Kar{\'e}n Matevosyan and Ramesh Bhagat and Cynthia Rutherford and Christopher Madden and Beshay, {Joseph E.}",
year = "2012",
month = "3",
doi = "10.3171/2011.11.JNS11836",
language = "English (US)",
volume = "116",
pages = "491--497",
journal = "Journal of Neurosurgery",
issn = "0022-3085",
publisher = "American Association of Neurological Surgeons",
number = "3",

}

TY - JOUR

T1 - Rapid warfarin reversal

T2 - A 3-factor prothrombin complex concentrate and recombinant factor VIIa cocktail for intracerebral hemorrhage: Clinical article

AU - Sarode, Ravi

AU - Matevosyan, Karén

AU - Bhagat, Ramesh

AU - Rutherford, Cynthia

AU - Madden, Christopher

AU - Beshay, Joseph E.

PY - 2012/3

Y1 - 2012/3

N2 - Object. Intracerebral hemorrhage (ICH) is the most serious bleeding complication of vitamin K antagonist (VKA) therapy, carrying a high mortality. Rapid reversal of VKA in ICH is critical. Plasma therapy, the standard of care in the US, is not optimal. The ideal prothrombin complex concentrate (PCC) containing all vitamin K-dependent factors (VKDFs) is not available in the US. Therefore, the authors developed a Trauma Coumadin Protocol (TCP) consisting of a 3-factor PCC available in the US (which contains insufficient factor VII [FVII]) with a low-dose recombinant FVIIa to rapidly reverse VKA. Methods. Forty-six patients treated with the TCP were retrospectively analyzed. Fourteen patients had pre- and post-TCP plasma samples collected to assess their VKDF increment. Eleven patients had measurable intraparenchymal hematomas, which were evaluated for expansion. Results. The mean pre- and post-TCP international normalized ratios (INRs) were 3.4 (median 2.9) and 1.0 (median 0.9), respectively. Once corrected, INR was maintained at < 1.3 during a patient's hospital stay. The pre-TCP median values of FII, FVII, FIX, and FX were 28%, 21%, 45%, and 20%, respectively; post-TCP median values increased to 144%, 417%, 102%, and 143%, respectively. Four of the 11 patients with measurable intraparenchymal hemorrhage had expansion at 24 hours after TCP. One patient probably (8 hours post-TCP) and 1 patient possibly (3 days post-TCP) had thrombotic complications. Conclusions. The TCP was very effective in rapidly reversing VKA-associated coagulopathy; however, this protocol should be used cautiously in patients at high risk for thrombosis.

AB - Object. Intracerebral hemorrhage (ICH) is the most serious bleeding complication of vitamin K antagonist (VKA) therapy, carrying a high mortality. Rapid reversal of VKA in ICH is critical. Plasma therapy, the standard of care in the US, is not optimal. The ideal prothrombin complex concentrate (PCC) containing all vitamin K-dependent factors (VKDFs) is not available in the US. Therefore, the authors developed a Trauma Coumadin Protocol (TCP) consisting of a 3-factor PCC available in the US (which contains insufficient factor VII [FVII]) with a low-dose recombinant FVIIa to rapidly reverse VKA. Methods. Forty-six patients treated with the TCP were retrospectively analyzed. Fourteen patients had pre- and post-TCP plasma samples collected to assess their VKDF increment. Eleven patients had measurable intraparenchymal hematomas, which were evaluated for expansion. Results. The mean pre- and post-TCP international normalized ratios (INRs) were 3.4 (median 2.9) and 1.0 (median 0.9), respectively. Once corrected, INR was maintained at < 1.3 during a patient's hospital stay. The pre-TCP median values of FII, FVII, FIX, and FX were 28%, 21%, 45%, and 20%, respectively; post-TCP median values increased to 144%, 417%, 102%, and 143%, respectively. Four of the 11 patients with measurable intraparenchymal hemorrhage had expansion at 24 hours after TCP. One patient probably (8 hours post-TCP) and 1 patient possibly (3 days post-TCP) had thrombotic complications. Conclusions. The TCP was very effective in rapidly reversing VKA-associated coagulopathy; however, this protocol should be used cautiously in patients at high risk for thrombosis.

KW - Concentrate

KW - Fresh-frozen plasma

KW - International normalized ratio

KW - Intracerebral hemorrhage

KW - Prothrombin complex

KW - Vitamin k

KW - Warfarin

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U2 - 10.3171/2011.11.JNS11836

DO - 10.3171/2011.11.JNS11836

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VL - 116

SP - 491

EP - 497

JO - Journal of Neurosurgery

JF - Journal of Neurosurgery

SN - 0022-3085

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