Cargando…

Use of Idarucizumab for dabigatran reversal: Emergency department experience in two cases with subdural haematoma

INTRODUCTION: Idarucizumab is the first effective humanized monoclonal antibody fragment developed specifically as a reversal agent for dabigatran, a Direct Oral Anticoagulant. Despite recent trials demonstrating reversal of clinically relevant bleeding, there is a paucity of data on use outside the...

Descripción completa

Detalles Bibliográficos
Autores principales: Edwards, Gail, Roman, Cristina, Jithoo, Rondhir, Mitra, Biswadev
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5887121/
https://www.ncbi.nlm.nih.gov/pubmed/29644298
http://dx.doi.org/10.1016/j.tcr.2017.12.003
_version_ 1783312234226647040
author Edwards, Gail
Roman, Cristina
Jithoo, Rondhir
Mitra, Biswadev
author_facet Edwards, Gail
Roman, Cristina
Jithoo, Rondhir
Mitra, Biswadev
author_sort Edwards, Gail
collection PubMed
description INTRODUCTION: Idarucizumab is the first effective humanized monoclonal antibody fragment developed specifically as a reversal agent for dabigatran, a Direct Oral Anticoagulant. Despite recent trials demonstrating reversal of clinically relevant bleeding, there is a paucity of data on use outside the trial setting. This manuscript describes the use of Idarucizumab to reverse dabigatran in two patients presenting to the emergency department of a major tertiary hospital with acute traumatic subdural haematomas (SDH). METHODS: Patients were identified through retrospective review of medication dispensing systems and electronic medical records. RESULTS: Two cases of Idarucizumab use were identified. Case 1 was of a 63-year-old male who presented following a motorcycle crash. Case 2 was of a 77-year-old male who presented with a 3-week history of ataxia and recurrent falls. Both patients were taking dabigatran for atrial fibrillation (AF). CT Brain revealed acute SDH with clinical indications for urgent surgical evacuation. Serum dabigatran levels were obtained on arrival in the emergency department with levels of 155 ng/ml and 110 ng/ml (reference range 117–275 ng/ml). Idarucizumab for dabigatran reversal was commenced; Case 1 received 5 g Idarucizumab as an intravenous bolus dose, while Case 2 received 5 g Idarucizumab as two 2.5 g intravenous infusions. Serum dabigatran levels for Cases 1 and 2 were 0 ng/ml at 75 min and 340 min post Idarucizumab administration respectively. Both patients proceeded to craniotomy with evacuation of the SDH. There was no extension of the SDH in either case. Anticoagulation was withheld until outpatient clinic review, and both patients transferred for rehabilitation prior to discharge home. CONCLUSION: Idarucizumab was clinically effective for reversing dabigatran, resulting in undetectable serum levels, and should be considered in patients presenting to hospital with clinically significant bleeding associated with dabigatran therapy.
format Online
Article
Text
id pubmed-5887121
institution National Center for Biotechnology Information
language English
publishDate 2017
publisher Elsevier
record_format MEDLINE/PubMed
spelling pubmed-58871212018-04-11 Use of Idarucizumab for dabigatran reversal: Emergency department experience in two cases with subdural haematoma Edwards, Gail Roman, Cristina Jithoo, Rondhir Mitra, Biswadev Trauma Case Rep Article INTRODUCTION: Idarucizumab is the first effective humanized monoclonal antibody fragment developed specifically as a reversal agent for dabigatran, a Direct Oral Anticoagulant. Despite recent trials demonstrating reversal of clinically relevant bleeding, there is a paucity of data on use outside the trial setting. This manuscript describes the use of Idarucizumab to reverse dabigatran in two patients presenting to the emergency department of a major tertiary hospital with acute traumatic subdural haematomas (SDH). METHODS: Patients were identified through retrospective review of medication dispensing systems and electronic medical records. RESULTS: Two cases of Idarucizumab use were identified. Case 1 was of a 63-year-old male who presented following a motorcycle crash. Case 2 was of a 77-year-old male who presented with a 3-week history of ataxia and recurrent falls. Both patients were taking dabigatran for atrial fibrillation (AF). CT Brain revealed acute SDH with clinical indications for urgent surgical evacuation. Serum dabigatran levels were obtained on arrival in the emergency department with levels of 155 ng/ml and 110 ng/ml (reference range 117–275 ng/ml). Idarucizumab for dabigatran reversal was commenced; Case 1 received 5 g Idarucizumab as an intravenous bolus dose, while Case 2 received 5 g Idarucizumab as two 2.5 g intravenous infusions. Serum dabigatran levels for Cases 1 and 2 were 0 ng/ml at 75 min and 340 min post Idarucizumab administration respectively. Both patients proceeded to craniotomy with evacuation of the SDH. There was no extension of the SDH in either case. Anticoagulation was withheld until outpatient clinic review, and both patients transferred for rehabilitation prior to discharge home. CONCLUSION: Idarucizumab was clinically effective for reversing dabigatran, resulting in undetectable serum levels, and should be considered in patients presenting to hospital with clinically significant bleeding associated with dabigatran therapy. Elsevier 2017-12-29 /pmc/articles/PMC5887121/ /pubmed/29644298 http://dx.doi.org/10.1016/j.tcr.2017.12.003 Text en © 2017 The Authors http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Article
Edwards, Gail
Roman, Cristina
Jithoo, Rondhir
Mitra, Biswadev
Use of Idarucizumab for dabigatran reversal: Emergency department experience in two cases with subdural haematoma
title Use of Idarucizumab for dabigatran reversal: Emergency department experience in two cases with subdural haematoma
title_full Use of Idarucizumab for dabigatran reversal: Emergency department experience in two cases with subdural haematoma
title_fullStr Use of Idarucizumab for dabigatran reversal: Emergency department experience in two cases with subdural haematoma
title_full_unstemmed Use of Idarucizumab for dabigatran reversal: Emergency department experience in two cases with subdural haematoma
title_short Use of Idarucizumab for dabigatran reversal: Emergency department experience in two cases with subdural haematoma
title_sort use of idarucizumab for dabigatran reversal: emergency department experience in two cases with subdural haematoma
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5887121/
https://www.ncbi.nlm.nih.gov/pubmed/29644298
http://dx.doi.org/10.1016/j.tcr.2017.12.003
work_keys_str_mv AT edwardsgail useofidarucizumabfordabigatranreversalemergencydepartmentexperienceintwocaseswithsubduralhaematoma
AT romancristina useofidarucizumabfordabigatranreversalemergencydepartmentexperienceintwocaseswithsubduralhaematoma
AT jithoorondhir useofidarucizumabfordabigatranreversalemergencydepartmentexperienceintwocaseswithsubduralhaematoma
AT mitrabiswadev useofidarucizumabfordabigatranreversalemergencydepartmentexperienceintwocaseswithsubduralhaematoma