Idarucizumab administration in emergency situations: the Munich Registry of Reversal of Pradaxa® in clinical routine (MR REPAIR)

J Neurol. 2019 Nov;266(11):2807-2811. doi: 10.1007/s00415-019-09492-w. Epub 2019 Aug 2.

Abstract

Objectives: To evaluate daily life management and functional outcome of Idarucizumab administration in case of emergency situations in patients with Dabigatran treatment.

Design: Multicenter observational registry study.

Setting: All hospitals with full neurological departments (n = 6) in Munich, Germany INCLUDED PATIENTS: All patients treated with Idarucizumab from 01/2016 to 03/2019.

Analyzed data: Indication and application of Idarucizumab, demographics and clinical parameters, and further interventions and treatments; clinical outcome was assessed with the modified Rankin scale (mRS) at 3 months after Idarucizumab administration RESULTS: Idarucizumab was administered to 32 patients for severe bleeding complications and ischemic strokes, more precisely for the following specific indications: intracranial bleeding (17 patients, 53%), ischemic stroke (8 patients, 25%), gastrointestinal bleeding (3 patients, 9%), femoral fracture, aortic dissection, and abdominal trauma and ileus (1 patient each, 3%). Additional coagulation management was performed in 7 patients (22%). Nine patients (28%) underwent emergency surgery. Seven patients (22%) received Idarucizumab before intravenous thrombolysis due to ischemic stroke and 4 of these 7 patients (13%) received mechanical thrombectomy in addition. Indication was mainly based on the history of Dabigatran intake and was irrespective of laboratory testing. At follow-up, 25% of the investigated patients had a mRS 0-2, while 25% had an unfavorable outcome (mRS 4-5). Mortality was 31%.

Conclusion: In our study, we have shown that the administration of Idarucizumab is a rare intervention and restricted to patients with severe bleeding complications or ischemic stroke. The clinical outcome of patients who received Idarucizumab in emergency situations was poor.

Keywords: Acute stroke; Dabigatran; Emergency; Emergency surgery; Idarucizumab; Intracerebral hemorrhage; Ischemic stroke; Oral anticoagulation.

Publication types

  • Multicenter Study
  • Observational Study

MeSH terms

  • Antibodies, Monoclonal, Humanized / therapeutic use*
  • Brain Ischemia / complications
  • Brain Ischemia / drug therapy
  • Dabigatran / antagonists & inhibitors
  • Emergency Medical Services / methods*
  • Germany
  • Hemorrhage / drug therapy
  • Humans
  • Registries
  • Stroke / drug therapy
  • Stroke / etiology

Substances

  • Antibodies, Monoclonal, Humanized
  • idarucizumab
  • Dabigatran