Rotational thromboelastometry for the transfusion management of postpartum hemorrhage after cesarean or vaginal delivery: A single-center randomized controlled trial

Postpartum hemorrhage (PPH) continues to be the leading cause of preventable maternal morbidity and mortality worldwide. Despite ample availability of resources in the United States, a database analysis demonstrated an increase in PPH from 2010 to 2014, from 2.9 to 3.2% [1]. Early detection of coagulopathy and tailored transfusion management may mitigate PPH and associated morbidity, as low fibrinogen (<200 mg/dL) at PPH onset predicts the progression to severe PPH and need for interventional procedures [2,3]. Rotational thromboelastometry (ROTEM®) point-of-care (POC) testing enables rapid assessment of global coagulation with specific detection of low-fibrinogen states and hyperfibrinolysis [4]. In addition to normal ROTEM® reference ranges for pregnant women that have been established for clinical use [5], [6], [7], [8], [9], [10], [11], prophylactic administration of fibrinogen concentrate is not indicated [12] and impactful ROTEM® thresholds for fibrinogen replacement are being defined [13,14].

Use of ROTEM® during PPH has demonstrated that coagulopathy is relatively rare and cannot be predicted solely by volume of blood lost [15]. Replacing a fixed-ratio massive transfusion protocol (“shock pack”) with a ROTEM®-based algorithm for fibrinogen replacement lowered the use of allogeneic blood products and improved transfusion-related patient outcomes after PPH [16]. However, contemporary practice precludes the empiric use of fixed ratio massive transfusion for PPH, and the effectiveness of ROTEM® for PPH has not been compared to empiric management in a randomized controlled setting. In this single center randomized controlled trial (RCT), we report the impact of ROTEM® on the transfusion management of PPH after cesarean delivery (CD) or vaginal delivery (VD). The primary aim was to compare the total number of blood products transfused in the intervention group compared to standard of care. Secondary aims were to compare transfusion-associated morbidity between groups. We hypothesized that ROTEM® use during PPH would lower total blood product transfusion number (including packed red blood cells [PRBC], fresh frozen plasma [FFP], platelets, cryoprecipitate, fibrinogen concentrate, or cell salvage units). Secondary outcomes included number of each product type transfused, transfusion-associated morbidity (i.e., hysterectomy rate, need for intensive care unit [ICU] admission, transfusion-associated circulatory overload [TACO], transfusion-related acute lung injury [TRALI]), and length of stay.

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