Skip to main content
Erschienen in: Neurocritical Care 1/2017

27.02.2017 | Original Article

Safety and Effectiveness of Factor VIII Inhibitor Bypassing Activity (FEIBA) and Fresh Frozen Plasma in Oral Anticoagulant-Associated Intracranial Hemorrhage: A Retrospective Analysis

verfasst von: Ellen B. Yin, Benedict Tan, Thuy Nguyen, Miguel Salazar, Kimberly Putney, Pramod Gupta, Jose I. Suarez, Eric M. Bershad

Erschienen in: Neurocritical Care | Ausgabe 1/2017

Einloggen, um Zugang zu erhalten

Abstract

Background

Oral anticoagulant (OAT)-associated intracranial hemorrhage (ICH) is a life-threatening emergency for which prothrombin complex concentrates (PCC) are considered first-line reversal agents. The only approved PCC in the USA for warfarin-associated ICH is non-activated PCC. Little data are available regarding the safety and effectiveness of factor VIII inhibitor bypassing activity (FEIBA) which is an activated prothrombin complex concentrate (aPCC). The aim of this analysis was to assess the safety and effectiveness of FEIBA compared to fresh frozen plasma (FFP) for reversal of OAT-associated ICH.

Methods

Data were retrospectively collected to compare coagulation markers and in-hospital clinical outcomes in patients who received aPCC with or without FFP versus FFP alone for the reversal of OAT-associated ICH.

Results

Eighty-four patients met inclusion criteria; 50 patients received FFP alone, and 34 patients received FEIBA (mean dose 20 U/kg) with or without FFP for OAT-associated ICH. The proportion of diagnosed thrombotic events during hospitalization was similar in both groups (8% in the FFP group vs. 12% in the FEIBA group; P = 0.56). Median time to INR < 1.5 was achieved faster in the FEIBA group versus the FFP group (0.5 h [IQR 0.5–1.] vs. 10 h [IQR 5–16.3], respectively; P < 0.001) reflecting a trend toward shorter median time to neurosurgical intervention. Hematoma expansion, length of stay, and all-cause mortality were similar between both groups.

Conclusions

Administration of FEIBA does not appear to increase the risk of thrombotic events compared with FFP. FEIBA administration resulted in faster INR reversal with a trend toward shorter time to neurosurgical intervention. However, there was no difference in hematoma expansion, mortality or length of stay.
Literatur
1.
Zurück zum Zitat Steiner T, Rosand J, Diringer M. Intracerebral hemorrhage associated with oral anticoagulant therapy: current practices and unresolved questions. Stroke. 2006;27:256–62.CrossRef Steiner T, Rosand J, Diringer M. Intracerebral hemorrhage associated with oral anticoagulant therapy: current practices and unresolved questions. Stroke. 2006;27:256–62.CrossRef
2.
Zurück zum Zitat Bershad E, Suarez J. Prothrombin complex concentrates for oral anticoagulant therapy-related intracranial hemorrhage: a review of the literature. Neurocrit Care. 2010;12:403–13.CrossRefPubMed Bershad E, Suarez J. Prothrombin complex concentrates for oral anticoagulant therapy-related intracranial hemorrhage: a review of the literature. Neurocrit Care. 2010;12:403–13.CrossRefPubMed
3.
Zurück zum Zitat Dowlatshahi D, Butcher KS, Asdaghi N, Nahirniak S, Bernbaum ML, Guilivi A, et al. Poor prognosis in warfarin-associated intracranial hemorrhage despite anticoagulation reversal. Stroke. 2012;43:1812–7.CrossRefPubMed Dowlatshahi D, Butcher KS, Asdaghi N, Nahirniak S, Bernbaum ML, Guilivi A, et al. Poor prognosis in warfarin-associated intracranial hemorrhage despite anticoagulation reversal. Stroke. 2012;43:1812–7.CrossRefPubMed
4.
Zurück zum Zitat Wojcik C, Schymik M, Cure E. Activated prothrombin complex concentrate factor VIII inhibitor bypassing activity (FEIBA) for the reversal of warfarin-induced coagulopathy. Int J Emerg Med. 2009;2:217–25.CrossRefPubMedPubMedCentral Wojcik C, Schymik M, Cure E. Activated prothrombin complex concentrate factor VIII inhibitor bypassing activity (FEIBA) for the reversal of warfarin-induced coagulopathy. Int J Emerg Med. 2009;2:217–25.CrossRefPubMedPubMedCentral
5.
Zurück zum Zitat Desmurs-Clavel H, Huchon C, Chatard B, Negrier C, Dargaud Y. Reversal of the inhibitory effect of fondaparinux on thrombin generation by rFVIIa, aPCC, and PCC. Thromb Res. 2009;123:796–8.CrossRefPubMed Desmurs-Clavel H, Huchon C, Chatard B, Negrier C, Dargaud Y. Reversal of the inhibitory effect of fondaparinux on thrombin generation by rFVIIa, aPCC, and PCC. Thromb Res. 2009;123:796–8.CrossRefPubMed
6.
Zurück zum Zitat Turecek PL, Varadi K, Gritsch H, Schwarz HP. FEIBA: mode of action. Haemophilia. 2004;10(Suppl 2):3–9.CrossRefPubMed Turecek PL, Varadi K, Gritsch H, Schwarz HP. FEIBA: mode of action. Haemophilia. 2004;10(Suppl 2):3–9.CrossRefPubMed
7.
Zurück zum Zitat Awad N, Cocchio C. Activated prothrombin complex concentrates for the reversal of anticoagulant-associated coagulopathy. Pharm Ther. 2013;38(11):696–701. Awad N, Cocchio C. Activated prothrombin complex concentrates for the reversal of anticoagulant-associated coagulopathy. Pharm Ther. 2013;38(11):696–701.
8.
9.
Zurück zum Zitat Lankiewicz MW, Hays J, Friedman KD, Tinkoff G, Blatt PM. Urgent reversal of warfarin with prothrombin complex concentrate. J Thromb Haemost. 2006;4:967–70.CrossRefPubMed Lankiewicz MW, Hays J, Friedman KD, Tinkoff G, Blatt PM. Urgent reversal of warfarin with prothrombin complex concentrate. J Thromb Haemost. 2006;4:967–70.CrossRefPubMed
10.
Zurück zum Zitat Pabinger I, Tiede A, Kalina U, Knaub S, Germann R, Ostermann H. Beriplex P/N anticoagulation reversal study group. Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate: a prospective clinical trial of emergency anticoagulation reversal. Ann Hematol. 2010;89:967–70.CrossRef Pabinger I, Tiede A, Kalina U, Knaub S, Germann R, Ostermann H. Beriplex P/N anticoagulation reversal study group. Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate: a prospective clinical trial of emergency anticoagulation reversal. Ann Hematol. 2010;89:967–70.CrossRef
11.
Zurück zum Zitat Bagot CN, Cregg R, Patel RK, Shariff A, Arya R. Perioperative myocardial infarction in a patient receiving low-dose prothrombin complex concentrates. Thromb Haemost. 2007;98:1141–2.PubMed Bagot CN, Cregg R, Patel RK, Shariff A, Arya R. Perioperative myocardial infarction in a patient receiving low-dose prothrombin complex concentrates. Thromb Haemost. 2007;98:1141–2.PubMed
12.
Zurück zum Zitat Imberti D, Barillari G, Biasioli C, Bianchi M, Contino L, Duce R, et al. Prothrombin complex concentrates for urgent anticoagulation reversal in patients with intracranial hemorrhage. Pathophysiol Haemost Thromb. 2007;36:256–65. Imberti D, Barillari G, Biasioli C, Bianchi M, Contino L, Duce R, et al. Prothrombin complex concentrates for urgent anticoagulation reversal in patients with intracranial hemorrhage. Pathophysiol Haemost Thromb. 2007;36:256–65.
13.
Zurück zum Zitat Teasdale G, Jennett B. Assessment of coma and impaired consciousness. Lancet. 1974;304(7872):81–4.CrossRef Teasdale G, Jennett B. Assessment of coma and impaired consciousness. Lancet. 1974;304(7872):81–4.CrossRef
14.
Zurück zum Zitat Brott T, Adams HP, Olinger C, Marler JR, Barsan WG, Biller J, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989;20(7):864–70.CrossRefPubMed Brott T, Adams HP, Olinger C, Marler JR, Barsan WG, Biller J, et al. Measurements of acute cerebral infarction: a clinical examination scale. Stroke. 1989;20(7):864–70.CrossRefPubMed
15.
Zurück zum Zitat Van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJA, Van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988;19:604–7.CrossRefPubMed Van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJA, Van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988;19:604–7.CrossRefPubMed
16.
Zurück zum Zitat Charlson ME, Pompei P, Ales K, Ronald MC. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373–83.CrossRefPubMed Charlson ME, Pompei P, Ales K, Ronald MC. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373–83.CrossRefPubMed
17.
Zurück zum Zitat Hemphill JC, Bonovich DC, Besmertis L, Manley GT, Johnston SC. The ICH score: a simple, reliable grading scale for intracerebral hemorrhage. Stroke. 2001;32(4):891–7.CrossRefPubMed Hemphill JC, Bonovich DC, Besmertis L, Manley GT, Johnston SC. The ICH score: a simple, reliable grading scale for intracerebral hemorrhage. Stroke. 2001;32(4):891–7.CrossRefPubMed
18.
Zurück zum Zitat Kothari RU, Brott T, Broderick JP, Barsan WG, Sauerbeck LR, Zuccarello M, et al. The ABCs of measuring intracerebral hemorrhage volumes. Stroke. 1996;27:1304–5.CrossRefPubMed Kothari RU, Brott T, Broderick JP, Barsan WG, Sauerbeck LR, Zuccarello M, et al. The ABCs of measuring intracerebral hemorrhage volumes. Stroke. 1996;27:1304–5.CrossRefPubMed
19.
Zurück zum Zitat Stewart WS, Pettit H. Experiences with an activated 4-factor prothrombin complex concentrate (FEIBA) for reversal of warfarin-related bleeding. Am J Emerg Med. 2013;31(8):1251–4.CrossRefPubMed Stewart WS, Pettit H. Experiences with an activated 4-factor prothrombin complex concentrate (FEIBA) for reversal of warfarin-related bleeding. Am J Emerg Med. 2013;31(8):1251–4.CrossRefPubMed
20.
Zurück zum Zitat Hickey M, Gatien M, Taljaard M, Aujnarain A, Giulivi A, Perry JJ. Outcomes of urgent warfarin reversal with frozen plasma versus prothrombin complex concentrate in the emergency department. Circulation. 2013;128:360–4.CrossRefPubMed Hickey M, Gatien M, Taljaard M, Aujnarain A, Giulivi A, Perry JJ. Outcomes of urgent warfarin reversal with frozen plasma versus prothrombin complex concentrate in the emergency department. Circulation. 2013;128:360–4.CrossRefPubMed
21.
Zurück zum Zitat Evans G, Luddington R, Baglin T. Beriplex P/N reverses severe warfarin-induced overanticoagulation immediately and completely in patients presenting with major bleeding. Br J Haematol. 2001;115:998–1001.CrossRefPubMed Evans G, Luddington R, Baglin T. Beriplex P/N reverses severe warfarin-induced overanticoagulation immediately and completely in patients presenting with major bleeding. Br J Haematol. 2001;115:998–1001.CrossRefPubMed
22.
Zurück zum Zitat Chapman SA, Irwin ED, Beal AL, Kulinski NM, Hutson KE, Thorson MA. Prothrombin complex concentrate versus standard therapies for INR reversal in trauma patients receiving warfarin. Ann Pharmacother. 2011;45(7–8):869–75.CrossRefPubMed Chapman SA, Irwin ED, Beal AL, Kulinski NM, Hutson KE, Thorson MA. Prothrombin complex concentrate versus standard therapies for INR reversal in trauma patients receiving warfarin. Ann Pharmacother. 2011;45(7–8):869–75.CrossRefPubMed
23.
Zurück zum Zitat Cabral KP, Fraser GL, Duprey J, Gibbons BA, Hayes T, Florman JE, Seder DB. Prothrombin complex concentrates to reverse warfarin-induced coagulopathy in patients with intracranial bleeding. Clin Neurol Neurosurg. 2013;115(6):770–4.CrossRefPubMed Cabral KP, Fraser GL, Duprey J, Gibbons BA, Hayes T, Florman JE, Seder DB. Prothrombin complex concentrates to reverse warfarin-induced coagulopathy in patients with intracranial bleeding. Clin Neurol Neurosurg. 2013;115(6):770–4.CrossRefPubMed
24.
Zurück zum Zitat Huttner HB, Schellinger PD, Hartmann M, Kohrmann M, Juettler E, Wikner J, et al. Hematoma growth and outcome in treated neurocritical care patients with intracerebral hemorrhage related to oral anticoagulant therapy: comparison of acute treatment strategies using vitamin K, fresh frozen plasma, and prothrombin complex concentrates. Stroke. 2006;37(6):1465–70.CrossRefPubMed Huttner HB, Schellinger PD, Hartmann M, Kohrmann M, Juettler E, Wikner J, et al. Hematoma growth and outcome in treated neurocritical care patients with intracerebral hemorrhage related to oral anticoagulant therapy: comparison of acute treatment strategies using vitamin K, fresh frozen plasma, and prothrombin complex concentrates. Stroke. 2006;37(6):1465–70.CrossRefPubMed
25.
Zurück zum Zitat Frontera JA, Gordon E, Zach V, Jovine M, Uchino K, Hussain M, Aledort L. Reversal of coagulopathy using prothrombin complex concentrates is associated with improved outcome compared to fresh frozen plasma in warfarin-associated intracranial hemorrhage. Neurocrit Care. 2014;21:397–406.CrossRefPubMed Frontera JA, Gordon E, Zach V, Jovine M, Uchino K, Hussain M, Aledort L. Reversal of coagulopathy using prothrombin complex concentrates is associated with improved outcome compared to fresh frozen plasma in warfarin-associated intracranial hemorrhage. Neurocrit Care. 2014;21:397–406.CrossRefPubMed
26.
Zurück zum Zitat Edavettal M, Rogers A, Rogers F, Horst M, Leng W. Prothrombin complex concentrate accelerates international normalized ratio reversal and diminishes the extension of intracranial hemorrhage in geriatric trauma patients. Am Surg. 2014;80(4):372–6.PubMed Edavettal M, Rogers A, Rogers F, Horst M, Leng W. Prothrombin complex concentrate accelerates international normalized ratio reversal and diminishes the extension of intracranial hemorrhage in geriatric trauma patients. Am Surg. 2014;80(4):372–6.PubMed
27.
Zurück zum Zitat Kuwashiro T, Yasaka M, Itabashi R, Nakagaki H, Miyashita F, Naritomi H, Minematsu K. Effect of prothrombin complex concentrate on hematoma enlargement and clinical outcome in patients with anticoagulant-associated intracerebral hemorrhage. Cerebrovasc Dis. 2001;31(2):170–6.CrossRef Kuwashiro T, Yasaka M, Itabashi R, Nakagaki H, Miyashita F, Naritomi H, Minematsu K. Effect of prothrombin complex concentrate on hematoma enlargement and clinical outcome in patients with anticoagulant-associated intracerebral hemorrhage. Cerebrovasc Dis. 2001;31(2):170–6.CrossRef
28.
Zurück zum Zitat Kuramatsu J, Gerner S, Schellinger P, Glahn J, Endres M, Sobseky J, Flechsenhar J, et al. Anticoagulant reversal, blood pressure levels, and anticoagulant resumption in patients with anticoagulation-related intracerebral hemorrhage. JAMA. 2015;313(8):824–36.CrossRefPubMed Kuramatsu J, Gerner S, Schellinger P, Glahn J, Endres M, Sobseky J, Flechsenhar J, et al. Anticoagulant reversal, blood pressure levels, and anticoagulant resumption in patients with anticoagulation-related intracerebral hemorrhage. JAMA. 2015;313(8):824–36.CrossRefPubMed
29.
Zurück zum Zitat Hemphill JC, Greenberg S, Anderson C, Becker K, Bendok BR, Cushman M, et al. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2015;46:1–30.CrossRef Hemphill JC, Greenberg S, Anderson C, Becker K, Bendok BR, Cushman M, et al. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2015;46:1–30.CrossRef
Metadaten
Titel
Safety and Effectiveness of Factor VIII Inhibitor Bypassing Activity (FEIBA) and Fresh Frozen Plasma in Oral Anticoagulant-Associated Intracranial Hemorrhage: A Retrospective Analysis
verfasst von
Ellen B. Yin
Benedict Tan
Thuy Nguyen
Miguel Salazar
Kimberly Putney
Pramod Gupta
Jose I. Suarez
Eric M. Bershad
Publikationsdatum
27.02.2017
Verlag
Springer US
Erschienen in
Neurocritical Care / Ausgabe 1/2017
Print ISSN: 1541-6933
Elektronische ISSN: 1556-0961
DOI
https://doi.org/10.1007/s12028-017-0383-x

Weitere Artikel der Ausgabe 1/2017

Neurocritical Care 1/2017 Zur Ausgabe

Leitlinien kompakt für die Neurologie

Mit medbee Pocketcards sicher entscheiden.

Seit 2022 gehört die medbee GmbH zum Springer Medizin Verlag

Hirnblutung unter DOAK und VKA ähnlich bedrohlich

17.05.2024 Direkte orale Antikoagulanzien Nachrichten

Kommt es zu einer nichttraumatischen Hirnblutung, spielt es keine große Rolle, ob die Betroffenen zuvor direkt wirksame orale Antikoagulanzien oder Marcumar bekommen haben: Die Prognose ist ähnlich schlecht.

Thrombektomie auch bei großen Infarkten von Vorteil

16.05.2024 Ischämischer Schlaganfall Nachrichten

Auch ein sehr ausgedehnter ischämischer Schlaganfall scheint an sich kein Grund zu sein, von einer mechanischen Thrombektomie abzusehen. Dafür spricht die LASTE-Studie, an der Patienten und Patientinnen mit einem ASPECTS von maximal 5 beteiligt waren.

Schwindelursache: Massagepistole lässt Otholiten tanzen

14.05.2024 Benigner Lagerungsschwindel Nachrichten

Wenn jüngere Menschen über ständig rezidivierenden Lagerungsschwindel klagen, könnte eine Massagepistole der Auslöser sein. In JAMA Otolaryngology warnt ein Team vor der Anwendung hochpotenter Geräte im Bereich des Nackens.

Schützt Olivenöl vor dem Tod durch Demenz?

10.05.2024 Morbus Alzheimer Nachrichten

Konsumieren Menschen täglich 7 Gramm Olivenöl, ist ihr Risiko, an einer Demenz zu sterben, um mehr als ein Viertel reduziert – und dies weitgehend unabhängig von ihrer sonstigen Ernährung. Dafür sprechen Auswertungen zweier großer US-Studien.

Update Neurologie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.