A Systems-Based Approach to Improve Fibrinogen Testing and Treatment of Low Fibrinogen in Patients Receiving Massive Transfusions: A Quality Improvement Initiative

Background: Uncontrolled hemorrhage is the most common treatable cause of death and four of every ten trauma patients die as a results of exsanguination, or its late effects (Curry et al. Scand J Trauma 2014). There is an increasing understanding of the state of acute coagulopathy and the role that fibrinogen plays in major hemorrhage (Wikkelso A et al. Cochrane Syst Rev 2013). Fibrinogen is a critical protein for hemostasis and clot formation. Low fibrinogen is a risk factor for hemorrhage in patients with major hemorrhage including surgical, obstetrics and trauma patients. Observational studies have reported improved survival with higher fibrinogen:RBC transfusion ratios in trauma.At Regions Hospital, St. Paul, MN, the Transfusion Committee observed that many patients receiving massive transfusions did not have fibrinogen activity tested.

Aim: To improve fibrinogen testing and treatment of low fibrinogen in patients receiving massive transfusions by using a hospital-wide, electronic medical record (EMR)-based Massive Transfusion Protocol (MTP) order set. Outcomes, including survival and transfusion requirements will also be evaluated.

Methods: Retrospective analysis of data from existing databases identified 127 patients who had massive hemorrhage as defined by activation of the massive transfusion protocol (MTP) at Regions Hospital between 2014-2016. We performed chart reviews to assess fibrinogen replacement practice 6 months before (n=68) and 6 months (n=59) after implementation of an EMR-based MTP order set in a quality improvement model. The order set automatically orders fibrinogen activity, in addition to hemoglobin, platelet count, INR, and PTT. Once the order set is activated, it will alert the provider to a low fibrinogen activity result using a best practice alert. The alert then directs therapy by opening the order for administration of cryoprecipitate. To evaluate the impact of this order set on fibrinogen testing and clinical outcomes, we constructed multivariable logistic regression models.

Results: During the study period, 127 patients had the MTP activated. The median age was 51 years and 67% were male. The majority of MTPs were activated for trauma (57%) located primarily in ED (64%). The common admitting diagnoses were motor vehicle accident (29%), heart surgery/procedure (18%), or GI bleed (16%). The admitting hemoglobin, platelet count, INR, and PTT were similar pre and post-intervention. Prior to the use of the MTP order set, only 32% of patients receiving the MTP had fibrinogen tested. Of the patients with a fibrinogen activity tested, over one-third had a low fibrinogen and of those 56% did not receive cryoprecipitate. Fibrinogen testing increased after the intervention (61% vs 32%, p=0.001), and among patients with low fibrinogen, transfusion of cryoprecipitate occurred more often (70% vs 44%, p=0.370). Blood transfusion requirements for red blood cells (7.0 vs 9.9, p=0.133), fresh-frozen plasma (4.9 vs 6.7, p=0.063), and platelets (1.2 vs 1.6, p=0.068) decreased post-intervention. In multivariate analysis, patients were approximately 3 times more likely to have fibrinogen activity tested after the intervention (OR 3.06, p=0.003). Deaths within 24 hours of MTP were more likely to occur among patients in the pre-intervention period (OR=1.45; 95% CI 0.42-5.00) and those with low fibrinogen (OR=1.34; 95% CI 0.26-7.08), however, due to the limited number of events, these estimates did not reach statistical significance.

Conclusions: A systems-based approach with a hospital-wide EMR order set for the MTP improved the testing for and treatment of low fibrinogen in patients with massive hemorrhage. This resulted in a trend towards improved outcomes. We did not achieve 100% fibrinogen testing after the intervention because the MTP can still be activated without using the order set, and this will be corrected in a future update. The treatment of patients with traumatic hemorrhage remains challenging and varies widely between trauma centers. Standardized treatment, automation of lab ordering, and the use of alerts can help providers improve the quality of care and clinical outcomes for patients.