Annals of Pharmacotherapy, Ahead of Print.
Background:Intracranial hemorrhage (ICH) exclusion criteria in the landmark four-factor prothrombin complex concentrate (4F-PCC) trial have not been incorporated into clinical practice and incremental predictive ability is unknown.Objectives:Evaluate the association of meeting at least 1 ICH exclusion criterion with the composite end point in-hospital mortality and modified Rankin Scale [mRS] score 5 or 6. Determine the number and combination of criteria associated with poor outcomes.Methods:Retrospective review of adult ICH patients who received 4F-PCC for anticoagulant reversal. Patient demographics, ICH exclusion criteria, in-hospital mortality, disability, and disposition were collected. χ2 Analysis and logistic regression were used to assess differences between patients with and without ICH exclusion criteria.Results:Data from 167 patients were analyzed: 103 (61.7%) met at least 1 ICH exclusion criterion. The composite end point occurred more in those with at least 1 ICH exclusion criterion (74.8% vs 39%; P < 0.0001). Presence of 2 or more ICH exclusion criteria was associated with higher odds of the composite end point, higher mRS score, and long-term care facility disposition (P < 0.0001). Glasgow Coma Scale score <7 and at least 1 other ICH exclusion criterion had negative effects on composite end point and mortality: 95% to 100% and 85% to 100%, respectively.Conclusion and Relevance:Patients meeting at least 1 ICH exclusion criterion had greater death/disability compared with those who did not. More ICH exclusion criteria were associated with higher rates of death, disability, and worse disposition. These data may aid in developing optimal 4F-PCC use criteria.
Background:Intracranial hemorrhage (ICH) exclusion criteria in the landmark four-factor prothrombin complex concentrate (4F-PCC) trial have not been incorporated into clinical practice and incremental predictive ability is unknown.Objectives:Evaluate the association of meeting at least 1 ICH exclusion criterion with the composite end point in-hospital mortality and modified Rankin Scale [mRS] score 5 or 6. Determine the number and combination of criteria associated with poor outcomes.Methods:Retrospective review of adult ICH patients who received 4F-PCC for anticoagulant reversal. Patient demographics, ICH exclusion criteria, in-hospital mortality, disability, and disposition were collected. χ2 Analysis and logistic regression were used to assess differences between patients with and without ICH exclusion criteria.Results:Data from 167 patients were analyzed: 103 (61.7%) met at least 1 ICH exclusion criterion. The composite end point occurred more in those with at least 1 ICH exclusion criterion (74.8% vs 39%; P < 0.0001). Presence of 2 or more ICH exclusion criteria was associated with higher odds of the composite end point, higher mRS score, and long-term care facility disposition (P < 0.0001). Glasgow Coma Scale score <7 and at least 1 other ICH exclusion criterion had negative effects on composite end point and mortality: 95% to 100% and 85% to 100%, respectively.Conclusion and Relevance:Patients meeting at least 1 ICH exclusion criterion had greater death/disability compared with those who did not. More ICH exclusion criteria were associated with higher rates of death, disability, and worse disposition. These data may aid in developing optimal 4F-PCC use criteria.
