PB0986 - Efficacy and safety of prothrombin complex concentrate for major bleeding in patients treated with direct Factor-Xa inhibitors

Tuesday, July 12, 2022

6:30 PM – 7:30 PM

Location: Exhibition

Presentation Format: In-Person

Presenting Author(s)

Rachel E. Clapham, MPharm

Anticoagulation Pharmacist
King's College Hospital NHS Foundation Trust
London, England, United Kingdom

Co-Author(s)

Victoria Speed, PhD

Specialist Anticoagulation Pharmacist
King's College Hospital NHS Foundation Trust
London, England, United Kingdom
KN

Kelly Nwankiti

Patient Blood Manager
Kings College Hospital
London, England, United Kingdom
Rosalind A. Byrne

Principal Pharmacist Anticoagulation
King's College Hospital NHS Foundation Trust
London, England, United Kingdom
JP

Jignesh P. Patel

Reader and Honorary Consultant Pharmacist in Anticoagulation
King's College Hospital NHS Foundation Trust
London, England, United Kingdom
Julia Czuprynska, MBBS MRCP FRCPath

Haematology Consultant
King's College Hospital
London, England, United Kingdom
RP

Raj K. Patel

Haematology Consultant
Kings College Hospital
London, England, United Kingdom
Roopen Arya, MA PhD FRCP FRCPath

Professor of Thrombosis and Haemostasis
King's College Hospital NHS Foundation Trust
London, England, United Kingdom
Lara N. Roberts, MD

Haematology Consultant
King's College Hospital NHS Foundation Trust
London, England, United Kingdom

Background: Treatment options for the reversal of direct Factor-Xa inhibitors have been limited due to the lack of antidote. Our current practice for the management of a major bleed is to use prothrombin complex concentrate (PCC).

Aims: To determine the efficacy and safety of PCC in patients treated with direct Factor-Xa inhibitors who present with major bleeding.

Methods: Patients issued with PCC between January 2019 and May 2021 were identified from blood bank records. The electronic patient record (EPR, Allscripts) was reviewed to identify use in patients on direct Factor-Xa inhibitors with major bleeding. Primary outcomes were 30-day mortality, re-bleeding and thrombosis.

Results: PCC was issued to 105 patients, of which 48 (45.7%) received PCC for major bleeding associated with direct factor Xa inhibitor use. Intracranial haemorrhage (ICH) was the most common indication for PCC reversal (see Table 1 for patient characteristics). Prior to admission, 7 patients were on concomitant antiplatelet or non-steroidal anti-inflammatory medications. 17/48 (35.4%) patients had a Xa-inhibitor drug level taken prior to receiving PCC. Nearly half of the patients received weight-based PCC with a median dose of 2000 units i.e. 23.4 units/kg (range 1000 -2500 units). 5/45 (11.1%) patients died, however major bleeding was listed as the cause of death for just three patients (ICH, GI bleed and large abdominal wall haematoma). There was one episode of re-bleeding where the patient developed an acute-on chronic subdural haematoma at 30 days. There were no thromboembolic events within 30-days of receiving PCC. 57.8% (26/45) of patients restarted anticoagulation after a median 14 days (range 1-301 days) and 10/26 (38.5%) of these were following ICH.

Conclusion(s): Our rates of mortality, re-bleeding and thrombosis were lower compared to current literature and suggest PCC to be a safe and effective option in the management of major bleeding in patients treated with direct Factor Xa inhibitors.