Title: The Incidence and Timing of Venous Thromboembolism After 4-Factor Prothrombin Complex Concentrate Administration in Trauma Patients
Authors: Gregory Gurin, Sharon Jordan, Aysu Erdemir
Grand Strand Medical Center – Myrtle Beach, SC
Background/Purpose: Non-activated 4-factor prothrombin complex concentrate (4F-PCC) has been increasingly utilized in trauma patients for hemostasis. This class of medication and the trauma population can increase the risk of thromboembolic complications, necessitating safe and effective prophylaxis. This study is designed to examine the relationship between incidence and timing of venous thromboembolism (VTE) with delayed prophylaxis after 4F-PCC administration in trauma patients.
Methodology: This retrospective study analyzed 2,664 patients aged ≥18 years admitted through the emergency department for traumatic injury and received ≥1 dose of 4F-PCC within 24 hours of arrival. Patients were noted to have high-risk trauma features that include traumatic brain injury, spinal cord injury, long bone fracture, pelvic fracture, and solid organ injury. The primary outcome was the incidence and timing of in-hospital venous thromboembolism. Secondary outcomes included in-hospital mortality, intensive care unit (ICU) admission, ICU length of stay (LOS), and 30-day mortality rate.
Results: Among patients in the final analytical cohort that received chemoprophylaxis, VTE occurred in 103 (3.9%) cases. VTE occurred in 5.1% of patients receiving delayed prophylaxis (>48 hours) compared with 2.4% of those receiving prophylaxis within 48 hours. Male sex (HR = 2.05, p < 0.001), history of VTE (HR = 5.59, p < 0.001) and solid organ injury (HR =2.43, p = 0.011) was associated with an increased risk of developing VTE. In survivors, the same risk factors increase the risk of VTE in addition to spinal cord injury (HR = 3.3, p = 0.017) and increased Elixhauser comorbidity score (HR = 1.16, p = 0.004). Concurrent use of pro-hemostatic agents (tranexamic acid and desmopressin) did not increase the risk of VTE. The median time from 4F-PCC administration to VTE was 135.1 hours (57.4-234.9 hours). Delayed prophylaxis was not associated with a higher risk of in-hospital mortality (HR 1.07; 95% CI 0.84–1.36; p = 0.60) or 30-day mortality (OR 1.10; 95% CI 0.86–1.39; p = 0.46). Delayed prophylaxis was associated with a 2.12-fold increase in the odds of ICU admission (OR = 2.12; 95% CI, 1.63–2.76; p < 0.001). Among patients with any ICU stay, delayed prophylaxis was associated with 60% longer ICU length of stay (IRR = 1.60; 95% CI, 1.46–1.76; p < 0.001). These results represent multivariable adjustments using major demographic and baseline clinical variables.
Conclusions: Delayed pharmacological VTE prophylaxis after 4F-PCC administration in trauma patients was not associated with higher risk of VTE or mortality. However, delayed prophylaxis was associated with increased ICU admission rates and longer ICU LOS. Although 4F-PCC was not associated with increased VTE risk or mortality, current medical management should continue to prioritize VTE prophylaxis once hemostasis has been achieved to minimize complications.
Contact email: [email protected]“This research was supported (in whole or in part) by HCA Healthcare and/or an HCA Healthcare affiliated entity. The views expressed in this publication represent those of the author(s) and do not necessarily represent the official views of HCA Healthcare or any of its affiliated entities.”
