Background: Recombinant and plasma-derived factor products, such as activated factor seven (rFVIIa) and four-factor prothrombin complex concentrate (4-factor PCC), have been used off-label for bleeding after cardiac surgery, but little evidence has been published regarding their efficacy and safety.
Objective: To determine whether there is a difference in chest tube output in patients who have received 4-factor PCC or rFVIIa for critical postoperative bleeding associated with cardiovascular surgery.
Methods: A retrospective chart review was conducted utilizing the electronic medical record system at a 657-bed community, tertiary care hospital in Nashville, Tennessee. Nonpregnant patients ≥18 years of age experiencing significant bleeding during cardiac surgery who received either PCC or rFVIIa perioperatively or postoperatively between April 2015 through December 2016 were eligible for inclusion. Patients were excluded if they received 4-factor PCC or rFVIIa for any indication other than bleeding during cardiac surgery or if they received both agents.
Results: Data conclude that there is no significant difference in chest tube output 24 hours postoperatively between patients treated with 4-factor PCC or rFVIIa. There was no difference in bleeding, thromboembolic events, or re-exploration between the rFVIIa and 4-factor PCC groups, but there was a difference in units of fresh frozen plasma administered and hospital length of stay.
Conclusion: 4-Factor PCC may be an equally efficacious alternative to rFVIIa for patients experiencing significant bleeding during cardiac surgery. There is no difference in chest tube output; therefore, there is no difference in bleeding-either at 24 hours postoperatively or total.
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http://dx.doi.org/10.1177/1060028017752365 | DOI Listing |
Neurohospitalist
January 2025
Department of Neurology, Division of Neurocritical Care, University of North Carolina, Chapel Hill, NC, USA.
Background/objectives: There is currently no consensus regarding the optimal strategy for reversal of anticoagulation in life-threatening hemorrhage associated with factor XIa (FXIa) inhibitors.
Methods: For this clinical case report, informed consent was obtained from surrogate.
Results And Discussion: Here, we present the case of an 82-year-old female who sustained a large subdural hematoma after a fall.
Clin Exp Emerg Med
January 2025
Department of Pharmacy Practice, Faculty of Pharmacy, King Abdulaziz University, Jeddah, Saudi Arabia.
Objectives: The objective of this systematic review and meta-analysis is to evaluate the efficacy, safety, time to INR reversal, total volume of 4-factor prothrombin complex concentrate (PCC) administered of fixed-dose versus weight-based dosing strategies in patients requiring urgent warfarin reversal, with specific focus on clinical outcomes such as hemostatic efficacy, thromboembolic events, and mortality rates.
Methods: A comprehensive systematic review was conducted using the PubMed, Embase, and Cochrane databases from inception through October 2023. We searched for randomized clinical trials or observational studies that compared efficacy or safety outcomes of fixed-dose vs.
Blood Coagul Fibrinolysis
January 2025
Department of Anesthesiology, Rush University Medical Center, Chicago, Illinois, USA.
Ann Pharmacother
November 2024
Department of Pharmacy, Houston Methodist Hospital, Houston, TX, USA.
Background: Rates of in-hospital venous thromboembolism (VTE) in the intracranial hemorrhage (ICH) population post oral anticoagulation (AC) reversal are as high as 10%. Guidelines recommend the initiation of prophylactic AC 24 to 48 hours post ICH; however, there is no guidance regarding optimal VTE prophylaxis post-reversal.
Objective: This study aimed to identify the incidence of thromboembolism post oral AC reversal in patients presenting with ICH and describe VTE prophylaxis timing and agent selection.
J Thromb Thrombolysis
October 2024
Department of Clinical Pharmacy and Outcomes Sciences, College of Pharmacy, University of South Carolina, 715 Sumter Street-CLS 316A, Columbia, SC, 29208, USA.
Multiple agents exist for the reversal of oral Factor Xa inhibitor (FXa) associated bleeding, including Coagulation FXa Recombinant, Inactivated zhzo (andexanet alfa) and 4-factor prothrombin complex concentrate (4F-PCC). While classified as a 3F-PCC product, Profilnine contains up to 35 IU of Factor VII (per 100 IU of Factor IX) in addition to therapeutic levels of Factors II, IX, and X, and has demonstrated a similar impact on prothrombin time and blood product usage in non-warfarin related bleeding. This was a retrospective, multicenter study at four medical centers of adult patients who presented with major bleeding associated with oral FXa inhibitors and received either 4F-PCC (n = 64) or 3F-PCC (n = 61).
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