Ashley Milkovits, PharmD, BCCCP
Ashley Milkovits, PharmD, BCCCP
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
Disclosure information not submitted.
.jpg "Miranda Thomas photo")
Hasan Kazmi, PharmD, BCPS, BCCP
Hasan Kazmi, PharmD, BCPS, BCCP
Carilion Roanoke Memorial Hospital, United States
Disclosure information not submitted.
Title: Evaluation of ECMO Bivalirudin Protocol
Introduction/Hypothesis: Traditionally, unfractionated heparin (UFH) was the systemic anticoagulant used during extracorporeal membrane oxygenation (ECMO). Recently, there has been increasing evidence to use bivalirudin, a direct thrombin inhibitor (DTI), due to fewer complications than with UFH. A medication use evaluation of all ECMO patients who received bivalirudin was previously conducted at Carilion, which resulted in a P&T approved addition of an ECMO Addendum in the pharmacy-directed DTI Protocol. The intent of this study was to evaluate the efficacy and safety of bivalirudin for systemic anticoagulation during ECMO support post protocol initiation.
Methods: This was a retrospective, single-center, quasi-experimental, pre-post study. The pre-group data collected previously was utilized. The post-protocol group was identified using a report from the electronic health record for adult patients on ECMO support for at least 24 hours and who received bivalirudin between May 1, 2019 and June 30, 2021.
Results: There were 38 patients in the pre- and 35 patients in the post-group. The primary outcome, median time to two consecutive aPTTs within therapeutic range for the initial goal range, was 8.9 hours in the pre- and 14.2 hours in the post-group (p=0.517). Removing nine COVID-19 patients from analysis, the median time in the post-group was 8.6 hours (p=0.615). After obtaining two consecutive therapeutic aPTTs, the median percentage of aPTTs that were outside the therapeutic range was 14.3%. There was no difference in a subgroup of patients with renal failure. The incidence of hemoglobin drop at least 3 g/dL was higher in the pre-group (23.7% vs. 11.4%, p=0.172). Major bleeding and systemic VTE occurred in 31.4% and 5.7% of the post-group, respectively. There was less circuit VTE in the post-group (89.5% vs. 68.6%, p=0.027). In a subgroup analysis of patients with and without COVID-19 in the post-group, the primary outcome was higher in patients with COVID-19 (26.5 vs. 14.2 hours, p=0.018). The median number of dose adjustments until the goal aPTT was achieved was also higher in COVID-19 patients (4 vs. 2, p=0.017).
Conclusions: Bivalirudin dosing is safe and effective after initiation of a pharmacy-driven protocol. Patients with COVID-19 on ECMO took longer to reach two consecutive aPTTs within therapeutic range.