BACKGROUND There is a resurgence in the use of low‐titer group O whole blood (LTOWB) for hemorrhagic shock. We hypothesized the use of LTOWB compared to component therapy (CT) would be independently associated with improved 24‐hour mortality. STUDY DESIGN AND METHODS In this prospective observational study, trauma patients 18 years of age or older with massive transfusion protocol activations were included from August 17, 2018, to May 14, 2019. The primary outcome was 24‐hour mortality. Secondary outcomes included 72‐hour blood product totals, multiple organ dysfunction scores (MODS), and 28‐day mortality. Multivariable logistic regression (MVLR) and Cox regression were performed to determine independent associations. RESULTS There were no clinically meaningful differences in measures of injury severity between study groups (CT, n = 42; LTOWB, n = 44). There was no difference in MODS between study groups. The unadjusted mortality was not statistically different between the study groups (9/42 [21%] for CT vs. 7/44 [16%] for LTOWB; p = 0.518). In the MVLR model, LTOWB increased the odds of 24‐hour survival by 23% (odds ratio 0.81, 95% confidence interval 0.69‐0.96; p = 0.017). Adjusted survival curve analysis indicated improved survival at both 24 hours and 28 days for LTOWB patients (p < 0.001). Further stratification showed an association between LTOWB use and survival when maximum clot firmness (MCF) was 60 mm or less (p = 0.009). CONCLUSIONS The use of LTOWB is independently associated with improved 24‐hour and 28‐day survival, and does not increase organ dysfunction at 72 hours. Use of LTOWB most impacted survival of patients with reduced clot firmness (MCF ≤60 mm). Collectively, these data support the clinical use and continued study of LTOWB for hemostatic resuscitation.
BACKGROUND There is renewed interest in the use of whole blood (WB) for resuscitation of patients in hemorrhagic shock. Leukoreduction with platelet‐sparing filters and pathogen reduction may be used to improve the safety profile of WB, yet the effects of leukoreduction and pathogen reduction on WB hemostatic function are not well characterized. STUDY DESIGN AND METHODS Blood from 32 healthy group O donors was divided into treatment groups (n = 8 for each group): untreated, pathogen reduced (PR+), leukoreduced using an in‐line filter (LR+), or PR+LR+. Units were stored without agitation for 21 days between 1° and 6°C, with sampling on days 0 (pre‐ and post‐treatments), 1, 3, 5, 10, 15, and 21 for hemostatic function as assessed by thromboelastometry, thrombin generation, platelet activation factors, and platelet impedance aggregometry. RESULTS From day 3 (D3) to D15 of storage, platelet count was reduced in PR+/LR+ units compared to PR−/LR− units. From D10 to D21 of storage, maximum clot firmness (MCF) was reduced in PR+/LR+ units compared to PR−/LR− units. From D3 to D21 of storage, platelet aggregation was reduced in PR+/LR+ units compared to PR−/LR− units. Total thrombin generation was similar in all groups from D0 to D21. CONCLUSIONS The combination of LR with a platelet‐sparing filter and PR significantly reduces hemostatic function compared to either treatment alone or untreated WB. The clinical consequences of LR and PR of WB in patients with severe bleeding should be examined in trials before both are used in combination in patients.
BACKGROUND Conventional platelet (PLT) storage at room temperature under continuous agitation results in a limited shelf life (5 days) and an increased risk of bacterial contamination. However, both of these aspects can be ameliorated by cold storage. Preliminary work has suggested that PLTs can be cold stored for up to 3 weeks, while preserving their metabolic activity longer than in PLTs stored at room temperature. As such, in the present study, we hypothesized that the metabolic phenotypes of PLTs stored at 4°C for 3 weeks could be comparable to that of room temperature–stored PLTs at 22°C for 5 days. Study Design and Methods Metabolomics analyses were performed on nine apheresis PLT concentrates stored either at room temperature (22°C) for 5 days or refrigerated conditions (4°C) for up to 3 weeks. RESULTS Refrigeration did not impact the rate of decline in glutamine or the intracellular levels of Krebs cycle metabolites upstream to fumarate and malate. It did, however, decrease oxidant stress (to glutathione and purines) and slowed down the activation of the pentose phosphate pathway, glycolysis, and fatty acid metabolism (acyl‐carnitines). CONCLUSION The overall metabolic phenotypes of 4°C PLTs at Storage Day 10 are comparable to PLTs stored at 22°C at the end of their 5‐day shelf life, while additional changes in glycolysis, purine, and fatty acid metabolism are noted by Day 21.
Background: The hemostatic properties of tranexamic acid (TXA) are well described, but the immunological effects of TXA administration after traumatic injury have not been thoroughly examined. We hypothesized TXA would reduce monocyte activation in bleeding trauma patients with severe injury. Methods: This was a single center, double-blinded, randomized controlled trial (RCT) comparing placebo to a 2 g or 4 g intravenous TXA bolus dose in trauma patients with severe injury. Fifty patients were randomized into each study group. The primary outcome was a reduction in monocyte activation as measured by human leukocyte antigen-DR isotype (HLA-DR) expression on monocytes 72 h after TXA administration. Secondary outcomes included kinetic assessment of immune and hemostatic phenotypes within the 72 h window post-TXA administration. Results: The trial occurred between March 2016 and September 2017, when data collection ended. 149 patients were analyzed (placebo, n = 50; 2 g TXA, n = 49; 4 g TXA, n = 50). The fold change in HLA-DR expression on monocytes [reported as median (Q1-Q3)] from pre-TXA to 72 h post-TXA was similar between placebo [0.61 (0.51-0.82)], 2 g TXA [0.57 (0.47-0.75)], and 4 g TXA [0.57 (0.44-0.89)] study groups (p = 0.82). Neutrophil CD62L expression was reduced in the 4 g TXA group [fold change:
Background Fibrinogen concentrates and cryoprecipitate are currently used for fibrinogen supplementation in bleeding patients with dysfibrinogenemia. Both products provide an abundant source of fibrinogen but take greater than 10 min to prepare for administration. Fibrinogen concentrates lack coagulation factors (i.e., factor VIII [FVIII], factor XIII [FXIII], von Willebrand factor [VWF]) important for robust hemostatic function. Cryoprecipitate products contain these factors but have short shelf lives (<6 h). Pathogen reduction (PR) of cryoprecipitate would provide a shelf‐stable immediately available adjunct containing factors important for rescuing hemostatic dysfunction. Study Design and Methods Hemostatic adjunct study products were psoralen‐treated PR‐cryoprecipitated fibrinogen complex (PR‐Cryo FC), cryoprecipitate (Cryo), and fibrinogen concentrates (FibCon). PR‐Cryo FC and Cryo were stored for 10 days at 20–24°C. Adjuncts were added to coagulopathies (dilutional, 3:7 whole blood [WB]:normal saline; or lytic, WB + 75 ng/ml tissue plasminogen activator), and hemostatic function was assessed by rotational thromboelastometry and thrombin generation. Results PR of cryoprecipitate did not reduce levels of FVIII, FXIII, or VWF. PR‐Cryo FC rescued dilutional coagulopathy similarly to Cryo, while generating significantly more thrombin than FibCon, which also rescued dilutional coagulopathy. Storage out to 10 days at 20–24°C did not diminish the hemostatic function of PR‐Cryo FC. Discussion PR‐Cryo FC provides similar and/or improved hemostatic rescue compared to FibCon in dilutional coagulopathies, and this rescue ability is stable over 10 days of storage. In hemorrhaging patients, where every minute delay is associated with a 5% increase in mortality, the immediate availability of PR‐Cryo FC has the potential to improve outcomes.
Background Screening for the risk of thromboembolism (TE) due to tranexamic acid (TXA) in patients with severe traumatic injury has not been performed in randomized clinical trials. Our objective was to determine if TXA dose was independently‐associated with thromboembolism. Study Design and Methods This is a secondary analysis of a single‐center, double‐blinded, randomized controlled trial comparing placebo to a 2‐g or 4‐g intravenous TXA bolus dose in trauma patients with severe injury. We used multivariable discrete‐time Cox regression models to identify associations with risk for thromboembolic events within 30 days post‐enrollment. Event curves were created using discrete‐time Cox regression. Results There were 50 patients in the placebo group, 49 in the 2‐g, and 50 in the 4‐g TXA group. In adjusted analyses for thromboembolism, a 2‐g dose of TXA had an hazard ratio (HR, 95% confidence interval [CI]) of 3.20 (1.12–9.11) (p = .029), and a 4‐g dose of TXA had an HR (95% CI) of 5.33 (1.94–14.63) (p = .001). Event curves demonstrated a higher probability of thromboembolism for both doses of TXA compared to placebo. Other parameters independently associated with thromboembolism include time from injury to TXA administration, body mass index, and total blood products transfused. Discussion In patients with severe traumatic injury, there was a dose‐dependent increase in the risk of at least one thromboembolic event with TXA. TXA should not be withheld, but thromboembolism screening should be considered for patients receiving a dose of at least 2‐g TXA intravenously for traumatic hemorrhage.
Aim: Central venous access ports (CVAP) are often required to deliver chemotherapy to cancer patients. Arm-sited CVAP are an alternative to traditional chest-sited CVAP, but their durability and complication rates have not been thoroughly compared. Methods: A retrospective analysis at a single institution was conducted of all patients who had a chest port inserted for chemotherapy over a 30-month period and compared to patients who had an arm port inserted over a subsequent 30-month period. The minimum follow-up period in patients who did not die from cancer was 6 months. The primary endpoint was successful use of the port, defined as a patient completing chemotherapy without a complication prompting removal of the port. Results: The success rate was not significantly different between arm port (92 patients) or chest port (49 patients) groups (88 vs 92%). There were no significant differences between infective or thrombotic complications in the two groups. Conclusion: Arm CVAP were found to be equivalent in durability and complications compared to chest CVAP for chemotherapy administration at a regional oncology unit.
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