Association of prothrombin complex concentrates administration and hematoma enlargement in NOAC-related intracerebral hemorrhage

Abstract

Objective: To investigate parameters associated with hematoma enlargement in non-vitamin-K-antagonist-anticoagulant(NOAC)-related intracerebral hemorrhage(ICH).

Methods: Retrospective cohort study including individual patient data of 190 patients with NOAC-associated ICH over a 5-year-period(2011-2015) at 19 Departments of Neurology across Germany. Primary outcome was the association of PCC-administration with hematoma enlargement. Subanalyses were calculated for blood-pressure management and its association with the primary outcome. Secondary outcomes include associations with in-hospital mortality and functional outcome at 3 months assessed using the modified Rankin scale.

Results: The study population for analysis of primary and secondary outcomes consisted of 146 NOAC-ICH-patients with available follow-up imaging. Hematoma enlargement occurred in 49/146(33.6%) patients with NOAC-related ICH. Parameters associated with hematoma enlargement were blood pressure above 160mmHg within 4hours and – in case of factor-Xa-inhibitor-ICH – anti-Xa-levels on admission. PCC-administration prior to follow-up imaging was not significantly associated with a reduced rate of hematoma enlargement neither in overall NOAC-related ICH nor in patients with factor-Xa-inhibitor intake (RR(95%CI):NOAC 1.150(0.632-2.090);factor-Xa-inhibitor: 1.057(0.565-1.977)), regardless of PCC-dosage given or time interval until imaging or treatment. Systolic blood pressure levels<160mmHg within 4 hours after admission were significantly associated with a reduction in the proportion of patients with hematoma enlargement (RR(95%CI):1.057(0.565-1.977)). PCC-administration had no effect on mortality and functional outcome neither at discharge nor at 3months.

Interpretation: In contrast to blood-pressure control, PCC-administration was not associated with a reduced rate of hematoma enlargement in NOAC-related ICH. Our findings support the need of further investigations exploring new hemostatic reversal strategies for patients with factor-Xa-inhibitor-related ICH. This article is protected by copyright. All rights reserved.

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