Background: 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. Methods: 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. Results: 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. Conclusions: 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.
There was no significant difference in unfavorable discharge disposition among neurosurgery ICU patients who were smokers treated with NRT, smokers not treated with NRT, and nonsmokers not treated with NRT.
Introduction: Opioid overuse in postoperative patients is a worrisome trend, and potential alternatives exist which warrant investigation. Nonsteroidal anti-inflammatory drug use in treating postoperative cranial surgery pain has been hampered by concern for inadequate pain control and increased risk of hemorrhagic complications. A safe and effective alternative to opioid-based pain management is critical to improving postoperative care. Objective: The objective of this retrospective study was to determine whether an NSAID-based opioid-sparing pain management protocol (OSP) is effective in analgesic control of less invasive cranial surgery patients at 6-, 12-, and 24-hour postoperatively. Secondary aims included investigating differences in hemorrhagic complications. Methods: Five hundred sixty-six consecutive patients who underwent cranial surgery before and after implementation of the celecoxib-based OSP were eligible. Propensity score matching was used to match patients in each cohort. Results: The opioid-sparing cohort had lower pain scores at 6 hours (3.45 vs 4.19, P 5 0.036), 12 hours (3.21 vs 4.00, P 5 0.006), and 24 hours (2.90 vs 3.59, P 5 0.010). Rates of postoperative hemorrhage were not significantly different (5% intervention vs 8% control, P 5 0.527). The opioid-sparing pain management protocol provided comparable or better pain control in the first 24 hours after less invasive cranial surgery. Hemorrhage rates did not change with the use of an NSAID-based OSP. Conclusion: An effective alternative to the current standard opioid-based pain management is feasible for less invasive cranial surgery. Determinations of hemorrhage risk and more complex cranial surgery will require larger prospective randomized trials.
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