Biotherapies, Cellular Therapies, and Immunotherapies
Susan M. Shea, n/a (she/her/hers)
University of Pittsburgh Department of Surgery
Pittsburgh, Pennsylvania, United States
Fibrinogen (FGN) supplementation is associated with improved outcomes in traumatically bleeding patients. Cryoprecipitate (cryo), a hemostatic adjunct given to replace FGN, contains other plasma proteins that may augment hemostatic resuscitation. Lyophilization of cryo (lyo-cryo) offers logistical benefits including long-term storage and immediate availability which could improve outcomes.
Study
Design/Methods: Fresh Frozen Plasma units were cold precipitated, pooled, and stored frozen or lyophilized, resulting in cryo or lyo-cryo, respectively. In vitro studies simulating hemostatic resuscitation in a model of trauma induced coagulopathy involved collecting healthy human blood and diluting 3:2 volumetrically with sterile normal saline. Healthy undiluted controls (n=17) and dilutional controls (n=7) were examined. For product testing, coagulopathic blood samples were mixed 10:1 volumetrically with cryo, lyo-cryo, or lactated ringer’s (LR) simulating theoretical fibrinogen supplementation of 1 mg/mL or crystalloid-only resuscitation (n=3/group). Samples were assessed via rotational thromboelastometry. Clot formation time (CFT) and maximum clot firmness (MCF) were observed via activation with tissue factor (TF) (EXTEM) or with TF and cytochalasin D (FIBTEM) to examine fibrinogen contribution with platelet inhibition. Statistics were run via one-way ANOVA and Tukey multiple comparisons test at 95% confidence interval.
Results/Findings:
Results are presented as mean +/- standard deviation in Table 1. Dilutional coagulopathy resulted in significantly impaired increases in EXTEM CFT and decreases in EXTEM MCF compared to healthy controls. When mixed with cryo and lyo-cryo, CFT was significantly improved compared to dilutional controls, however LR was not. A similar but not statistically significant trend was observed with MCF. In fibrinogen contributions alone, CFT and MCF significantly improved with cryo and lyo-cryo resuscitation compared to coagulopathy alone, coagulopathy mixed with LR, and even healthy controls in CFT specifically.
Conclusions: Lyophilized products provide logistical advantages and show no significant differences compared to non-lyophilized cryo. Further studies are needed to determine potential benefits in other coagulopathy models in addition to clinical trials.