Prothrombin complex concentrates for urgent anticoagulation reversal in patients with intracranial haemorrhage

D. Imberti, G. Barillari, C. Biasioli, M. Bianchi, L. Contino, R. Duce, M. D'Incà, L. Mameli, L. Pinna, W. Ageno

Research output: Contribution to journalArticle

31 Citations (Scopus)

Abstract

Background: Intracranial haemorrhage (ICH) is a serious and potentially fatal complication of oral anticoagulant therapy (OAT). Prothrombin complex concentrates (PCCs) produce a rapid and effective reversal of OAT effects, but little evidence exists on their efficacy and safety in the management of ICH in patients on OAT. Aim:To evaluate the efficacy and safety of PCCs for the rapid reversal of OAT in patients with ICH. Methods: Patients suffering from acute ICH while receiving OAT were eligible for this prospective cohort study if their international normalized ratio (INR) was ≥2.0. Stratified 35-50 IU kg -1 PCC doses were infused based on initial INR. Results: A total of 92 patients (50 males; mean age 74 years, range 34-92 years) were included. The median INR at presentation was 3.3 (range 2-9). At 30 min after PCC administration the median INR was 1.4 (range 0.9-3.1), declining to ≤1.5 in 75% of patients. The benefit of PCC was maintained for a long time, since in 98% of all post-infusion time points through 96 h the median INR remained ≤1.5 (median 1.19; range 0.9-2.3). During hospitalization neither thrombotic complications nor significant adverse events were observed and 11 patients died (11.9%). None of the deaths was judged to be related to PCC administration. Conclusions: PCC administration is an effective, rapid and safe treatment for the urgent reversal of OAT in patients with ICH. Broader use of PCC in this clinical setting appears to be appropriate.

Original languageEnglish
Pages (from-to)259-265
Number of pages7
JournalPathophysiology of Haemostasis and Thrombosis
Volume36
Issue number5
DOIs
Publication statusPublished - 2008

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Intracranial Hemorrhages
International Normalized Ratio
Anticoagulants
Therapeutics
Safety Management
prothrombin complex concentrates
Hospitalization
Cohort Studies
Prospective Studies
Safety

Keywords

  • Intracranial haemorrhage
  • Oral anticoagulants
  • Prothrombin complex concentrates

ASJC Scopus subject areas

  • Hematology
  • Physiology (medical)

Cite this

Prothrombin complex concentrates for urgent anticoagulation reversal in patients with intracranial haemorrhage. / Imberti, D.; Barillari, G.; Biasioli, C.; Bianchi, M.; Contino, L.; Duce, R.; D'Incà, M.; Mameli, L.; Pinna, L.; Ageno, W.

In: Pathophysiology of Haemostasis and Thrombosis, Vol. 36, No. 5, 2008, p. 259-265.

Research output: Contribution to journalArticle

Imberti, D, Barillari, G, Biasioli, C, Bianchi, M, Contino, L, Duce, R, D'Incà, M, Mameli, L, Pinna, L & Ageno, W 2008, 'Prothrombin complex concentrates for urgent anticoagulation reversal in patients with intracranial haemorrhage', Pathophysiology of Haemostasis and Thrombosis, vol. 36, no. 5, pp. 259-265. https://doi.org/10.1159/000252822
Imberti, D. ; Barillari, G. ; Biasioli, C. ; Bianchi, M. ; Contino, L. ; Duce, R. ; D'Incà, M. ; Mameli, L. ; Pinna, L. ; Ageno, W. / Prothrombin complex concentrates for urgent anticoagulation reversal in patients with intracranial haemorrhage. In: Pathophysiology of Haemostasis and Thrombosis. 2008 ; Vol. 36, No. 5. pp. 259-265.
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AU - Imberti, D.

AU - Barillari, G.

AU - Biasioli, C.

AU - Bianchi, M.

AU - Contino, L.

AU - Duce, R.

AU - D'Incà, M.

AU - Mameli, L.

AU - Pinna, L.

AU - Ageno, W.

PY - 2008

Y1 - 2008

N2 - Background: Intracranial haemorrhage (ICH) is a serious and potentially fatal complication of oral anticoagulant therapy (OAT). Prothrombin complex concentrates (PCCs) produce a rapid and effective reversal of OAT effects, but little evidence exists on their efficacy and safety in the management of ICH in patients on OAT. Aim:To evaluate the efficacy and safety of PCCs for the rapid reversal of OAT in patients with ICH. Methods: Patients suffering from acute ICH while receiving OAT were eligible for this prospective cohort study if their international normalized ratio (INR) was ≥2.0. Stratified 35-50 IU kg -1 PCC doses were infused based on initial INR. Results: A total of 92 patients (50 males; mean age 74 years, range 34-92 years) were included. The median INR at presentation was 3.3 (range 2-9). At 30 min after PCC administration the median INR was 1.4 (range 0.9-3.1), declining to ≤1.5 in 75% of patients. The benefit of PCC was maintained for a long time, since in 98% of all post-infusion time points through 96 h the median INR remained ≤1.5 (median 1.19; range 0.9-2.3). During hospitalization neither thrombotic complications nor significant adverse events were observed and 11 patients died (11.9%). None of the deaths was judged to be related to PCC administration. Conclusions: PCC administration is an effective, rapid and safe treatment for the urgent reversal of OAT in patients with ICH. Broader use of PCC in this clinical setting appears to be appropriate.

AB - Background: Intracranial haemorrhage (ICH) is a serious and potentially fatal complication of oral anticoagulant therapy (OAT). Prothrombin complex concentrates (PCCs) produce a rapid and effective reversal of OAT effects, but little evidence exists on their efficacy and safety in the management of ICH in patients on OAT. Aim:To evaluate the efficacy and safety of PCCs for the rapid reversal of OAT in patients with ICH. Methods: Patients suffering from acute ICH while receiving OAT were eligible for this prospective cohort study if their international normalized ratio (INR) was ≥2.0. Stratified 35-50 IU kg -1 PCC doses were infused based on initial INR. Results: A total of 92 patients (50 males; mean age 74 years, range 34-92 years) were included. The median INR at presentation was 3.3 (range 2-9). At 30 min after PCC administration the median INR was 1.4 (range 0.9-3.1), declining to ≤1.5 in 75% of patients. The benefit of PCC was maintained for a long time, since in 98% of all post-infusion time points through 96 h the median INR remained ≤1.5 (median 1.19; range 0.9-2.3). During hospitalization neither thrombotic complications nor significant adverse events were observed and 11 patients died (11.9%). None of the deaths was judged to be related to PCC administration. Conclusions: PCC administration is an effective, rapid and safe treatment for the urgent reversal of OAT in patients with ICH. Broader use of PCC in this clinical setting appears to be appropriate.

KW - Intracranial haemorrhage

KW - Oral anticoagulants

KW - Prothrombin complex concentrates

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