rivaroxaban and Hematoma--Subdural

To report 3 cases of subdural bleeding associated with rivaroxaban managed by 3-factor prothrombin complex concentrate (PCC3).. Case 1 presented with a 1-cm thick subdural hematoma (SDH) 12 hours after her last dose of rivaroxaban. Case 2 presented with a right 1-cm acute right SDH with 2 to 3 mm of midline shift 24 hours after his last dose of rivaroxaban. Case 3 presented with a 1.8-cm thick right cerebral convexity hematoma 12 hours after her last dose of rivaroxaban. All patients received 23 to 35 units/kg PCC3 with 1 to 3 units of fresh frozen plasm (FFP) and demonstrated no progression in lesions measured by repeat computed tomography (CT). Two patients were discharged to rehabilitation facilities and 1 patient ultimately died due to the location of the lesion.. Rivaroxaban has no specific antidote. Current bleeding management strategies are based on expert opinion. The risks and benefits for differing strategies are unclear, and no clinical experience has been reported to date. These cases begin to illuminate differences among choices for managing bleeding associated with Xa inhibitors.. In this case series, 25 to 35 units/kilogram PCC3 and FFP 1 to 3 units ceased rivaroxaban-associated bleeding without thrombogenic complications.

Topics: Aged; Aged, 80 and over; Animals; Blood Coagulation Factors; Disease Management; Factor Xa Inhibitors; Female; Hematoma, Subdural; Hemorrhage; Humans; Male; Rivaroxaban

Since the approval of the oral factor Xa inhibitors, there have been concerns regarding the ability to neutralize their anticoagulant effects after intracranial hemorrhage (ICH). Multiple guidelines suggest using prothrombin complex concentrates (PCCs) in these patients on the basis of research that includes a limited number of patients with ICH. Given this, we aimed to evaluate the safety and efficacy of PCCs for factor Xa inhibitor-related ICH in a large, multicenter cohort of patients.. This was a multicenter, retrospective, observational cohort study of patients with apixaban- or rivaroxaban-related ICH who received PCCs between January 1, 2015, and March 1, 2019. The study had 2 primary analysis groups: safety and hemostatic efficacy. The safety analysis evaluated all patients meeting inclusion criteria for the occurrence of a thrombotic event, which were censored at hospital discharge or 30 days after PCC administration. Patients with intracerebral, subarachnoid, or subdural hemorrhages who had at least 1 follow-up image within 24 hours of PCC administration were assessed for hemostatic efficacy. The primary efficacy outcome was the percentage of patients with excellent or good hemostasis on the basis of the modified Sarode criteria. Secondary outcomes included an evaluation of in-hospital mortality, length of stay, infusion-related reactions, and thrombotic event occurrence during multiple predefined periods.. A total of 663 patients were included and assessed for safety outcomes. Of these, 433 patients met criteria for hemostatic efficacy evaluation. We observed excellent or good hemostasis in 354 patients (81.8% [95% CI, 77.9-85.2]). Twenty-five (3.8%) patients had a total of 26 thrombotic events, of which 22 occurred in the first 14 days after PCC administration. One patient had documentation of an infusion-related reaction. For the full cohort of patients, in-hospital mortality was 19.0%, and the median intensive care unit and hospital lengths of stay were 2.0 and 6.0 days, respectively.. Administration of PCCs after apixaban- and rivaroxaban-related ICH provided a high rate of excellent or good hemostasis (81.8%) coupled with a 3.8% thrombosis rate. Randomized, controlled trials evaluating the clinical efficacy of PCCs in patients with factor Xa inhibitor-related ICH are needed.

Topics: Aged; Blood Coagulation Factors; Factor Xa Inhibitors; Female; Hematoma, Subdural; Hemostasis; Hemostatics; Hospital Mortality; Humans; Intracranial Thrombosis; Length of Stay; Male; Middle Aged; Pyrazoles; Pyridones; Retrospective Studies; Risk Factors; Rivaroxaban; Subarachnoid Hemorrhage; Time Factors; Treatment Outcome; United States

Topics: Aged; Atrial Fibrillation; Blood Coagulation Tests; Factor Xa Inhibitors; Hematoma, Subdural; Hemorrhage; Humans; Male; Prothrombin Time; Rivaroxaban

Topics: Accidental Falls; Aged; Antibodies, Monoclonal, Humanized; Anticoagulants; Factor Xa; Female; Headache; Hematoma, Subdural; Humans; Radiography; Recombinant Proteins; Rivaroxaban; Stroke; Withholding Treatment

The management of life-threatening bleeding associated with rivaroxaban remains a challenge for physicians due to the lack of evidence about clinically effective options for anticoagulation reversal. We report a favorable outcome in a patient receiving rivaroxaban prophylaxis, who developed a spontaneous subdural hematoma treated by a surgical evacuation and administration of 4-factor prothrombin complex concentrate. Classical coagulation variables were associated with impaired thrombin generation. Reversal with prothrombin complex concentrates improved all thrombin generation measures. Thrombin generation tests may be suitable for assessing the clinical utility of reversal drugs on rivaroxaban-induced coagulopathy.

Topics: Aged; Anticoagulants; Blood Coagulation; Blood Coagulation Factors; Blood Coagulation Tests; Cerebral Hemorrhage; Factor Xa Inhibitors; Hematoma, Subdural; Humans; Male; Rivaroxaban; Thrombin

Topics: Accidental Falls; Aged; Anticoagulants; Blood Coagulation; Blood Coagulation Factors; Coma; Female; Glasgow Coma Scale; Hematoma, Subdural; Humans; Morpholines; Rivaroxaban; Thiophenes; Ultrasonography, Doppler, Transcranial