Dabigatran, an alternative to warfarin for prevention of stroke with non-valvular atrial fibrillation (AF), offers advantages of a fixed dosage, minimal laboratory monitoring and limited medication interactions. Dabigatran requires dosage adjustment in renal dysfunction and is contraindicated if severe dysfunction. No identified dabigatran reversal agent exists.
Methods: As part of an ongoing quality initiative, novel anticoagulant associated adverse events (AE) are monitored at a dedicated neuroscience hospital.
Results: 5 cases of intracranial bleeding associated with dabigatran occurred from 12/2011-4/2012. All patients were on anticoagulation for AF, the most common dose of dabigatran was 150 mg BID. Mean admission values were as follows: age 83.2 yrs (range 79-90), serum creatinine 1.48 mg/dL (range 0.9- 3.5), creatinine clearance 45.6 mL/min (18-59) and aPTT 49 seconds (range 32- 60). Strategies for the management of bleeding included withholding dabigatran, supportive care, administration of blood products and hemodialysis, when required. Dialysis was initiated on 3 patients. One patient had 3 dialysis sessions in an effort to normalize coagulation assays and had transfusions with 10 units of platelets and 4 units of fresh frozen plasma in an effort to stabilize bleeding. One patient died. Mean time for aPTT to normalize when abnormal on admission was 30.8 hours (range 21-37).
Conclusions: Appropriate patient selection is required to prevent dabigatran associated AE, especially in the setting of advanced age and kidney dysfunction. aPTT values may remain prolonged for extended periods, despite efforts to normalize. Hospitals need a defined management plan for major bleeding associated with novel anticoagulants.
Recommended CitationPerez, MD, Alejandro; Thomson, Lynda; and Merli, MD, Geno J., "Management of intracranial bleeding associated with dabigatran use in a neuroscience hospital" (2013). Department of Pharmacology and Experimental Therapeutics Faculty Papers. Paper 43.