Adverse events following international normalized ratio reversal in intracerebral hemorrhage
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Supporting information
Supporting information
Author(s)
Type
Journal Article
Abstract
Background: Prothrombin complex concentrates (PCCs) are frequently used to reverse the effect of vitamin K antagonists (VKAs) in patients with non-traumatic intracerebral hemorrhage (ICH). However, information on the rate of thromboembolic events (TEs) and allergic events after PCC therapy in VKA-ICH patients is limited. Methods: Consecutive VKA-ICH patients treated with PCC at our institution between December 2004 and June 2014 were included into this retrospective observational study. We recorded international normalized ratio (INR) values before and after PCC treatment, baseline clinical characteristics including the premorbid modified Rankin Scale (pmRS) score, TE and allergic event that occurred during the hospital stay. All events were classified by 3 reviewers as being ‘related', ‘probably related', ‘possibly related', ‘unlikely related' or ‘not related' to treatment with PCC. To identify factors associated with TEs, log-rank analyses were applied. Results: Two hundred and five patients were included. Median INR was 2.8 (interquartile range (IQR) 2.2-3.8) before and 1.3 (IQR 1.2-1.4) after PCC treatment and a median of 1,500 IU PCC (IQR 1,000-2,500) was administered. Nineteen TEs were observed (9.3%); none were classified ‘related' but 9 were classified as ‘possibly' or ‘probably related' to PCC infusion (4.4%). One allergic reaction (0.5%), ‘unlikely related' to PCC, was observed. In the whole cohort, PCC doses >2,000-3,000 IU, ICH volumes >40 ml, National Institute of Health Stroke Scale values >10 and a pmRS >2 were associated with the development of TEs (p = 0.031, p = 0.034, p = 0.050 and p = 0.036, respectively). Conclusions: Overall, INR reversal with PCC appears safe. Though no clear relationship between higher PCC dosing and TEs was observed, PCC doses between >2,000 and 3,000 IU and higher morbidity at ICH onset were associated with TEs. Hence, individual titration of PCC to avoid exposure to unnecessarily high doses using point-of-care devices should be prospectively explored.
Date Issued
2016-08-19
Date Acceptance
2016-07-26
Citation
Cerebrovascular Diseases, 2016, 42 (5-6), pp.446-454
ISSN
1015-9770
Publisher
Karger Publishers
Start Page
446
End Page
454
Journal / Book Title
Cerebrovascular Diseases
Volume
42
Issue
5-6
Copyright Statement
© 2016 S. Karger AG, Basel.
Sponsor
St Marys Development Trust
St Marys Development Trust
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000390030800017&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Grant Number
RE:SOBELL CHAIR
N/A
Subjects
Science & Technology
Life Sciences & Biomedicine
Clinical Neurology
Peripheral Vascular Disease
Neurosciences & Neurology
Cardiovascular System & Cardiology
Prothrombin complex concentrate
Vitamin K antagonists
Intracerebral hemorrhage
Reversal treatment
Thromboembolic event
Allergic reaction
PROTHROMBIN COMPLEX CONCENTRATE
ASSOCIATION/AMERICAN-STROKE-ASSOCIATION
HEALTH-CARE PROFESSIONALS
VITAMIN-K ANTAGONISTS
FRESH-FROZEN PLASMA
ANTICOAGULATION REVERSAL
INTRACRANIAL HEMORRHAGE
THROMBOEMBOLIC EVENTS
ORAL ANTICOAGULATION
HEMATOMA EXPANSION
Publication Status
Published