ImportanceOptimal transfusion strategies in traumatic hemorrhage are unknown. Reports suggest a beneficial effect of 4-factor prothrombin complex concentrate (4F-PCC) on blood product consumption.ObjectiveTo investigate the efficacy and safety of 4F-PCC administration in patients at risk of massive transfusion.Design, Setting, and ParticipantsDouble-blind, randomized, placebo-controlled superiority trial in 12 French designated level I trauma centers from December 29, 2017, to August 31, 2021, involving consecutive patients with trauma at risk of massive transfusion. Follow-up was completed on August 31, 2021.InterventionsIntravenous administration of 1 mL/kg of 4F-PCC (25 IU of factor IX/kg) vs 1 mL/kg of saline solution (placebo). Patients, investigators, and data analysts were blinded to treatment assignment. All patients received early ratio-based transfusion (packed red blood cells:fresh frozen plasma ratio of 1:1 to 2:1) and were treated according to European traumatic hemorrhage guidelines.Main Outcomes and MeasuresThe primary outcome was 24-hour all blood product consumption (efficacy); arterial or venous thromboembolic events were a secondary outcome (safety).ResultsOf 4313 patients with the highest trauma level activation, 350 were eligible for emergency inclusion, 327 were randomized, and 324 were analyzed (164 in the 4F-PCC group and 160 in the placebo group). The median (IQR) age of participants was 39 (27-56) years, Injury Severity Score was 36 (26-50 [major trauma]), and admission blood lactate level was 4.6 (2.8-7.4) mmol/L; prehospital arterial systolic blood pressure was less than 90 mm Hg in 179 of 324 patients (59%), 233 patients (73%) were men, and 226 (69%) required expedient hemorrhage control. There was no statistically or clinically significant between-group difference in median (IQR) total 24-hour blood product consumption (12 [5-19] U in the 4F-PCC group vs 11 [6-19] U in the placebo group; absolute difference, 0.2 U [95% CI, −2.99 to 3.33]; P = .72). In the 4F-PCC group, 56 patients (35%) presented with at least 1 thromboembolic event vs 37 patients (24%) in the placebo group (absolute difference, 11% [95% CI, 1%-21%]; relative risk, 1.48 [95% CI, 1.04-2.10]; P = .03).Conclusions and RelevanceAmong patients with trauma at risk of massive transfusion, there was no significant reduction of 24-hour blood product consumption after administration of 4F-PCC, but thromboembolic events were more common. These findings do not support systematic use of 4F-PCC in patients at risk of massive transfusion.Trial RegistrationClinicalTrials.gov Identifier: NCT03218722
BACKGROUNDVeno-venous extracorporeal membrane oxygenation (vv-ECMO) has been progressively integrated into the standards of care for severe acute respiratory distress syndrome (ARDS). [1][2][3] Although initiation criteria are still under debate, the efficiency of ECMO in extreme physiologic conditions is fully demonstrated by gas exchanges and the ability to
Background:The aim of this study was to assess the interdependence of extracorporeal blood flow (Qec) and gas flow (GF) in predicting CO 2 removal and reduction of minute mechanical ventilation under extracorporeal respiratory support.Methods: All patients who benefited from V-V ECMO and high-flow ECCO 2 R in our intensive care unit over a period of 18 months were included. CO 2 removal was calculated from inlet/outlet blood port gases during the first 7 days of oxygenator use. The relationship between the Qec × GF product (named decarboxylation index and expressed in L 2 /min 2 ) and CO 2 removal or expired minute mechanical ventilation reduction ( EC MV ratio) was studied using linear regression models.Results: Eighteen patients were analyzed, corresponding to 24 oxygenators and 261 datasets. CO 2 removal was 393 ml/min (IQR, 310-526) for 1.8 m 2 oxygenators and 179 ml/min (IQR, 165-235) for 1.3 m 2 oxygenators. The decarboxylation index was associated linearly with CO 2 removal (R 2 = 0.62 and R 2 = 0.77 for the two oxygenators, respectively) and EC MV ratio (R 2 = 0.72 and R 2 = 0.62, respectively). The 20L 2 /min 2 value (considering Qec = 2 L/min and GF = 10 L/min) was associated with an EC MV ratio between 61% and 29% for 1.8 m 2 oxygenators, and between 62% and 38% for 1.3 m 2 oxygenators. Conclusion:The decarboxylation index is a simple parameter to predict CO 2 removal and EC MV ratio under extracorporeal respiratory support.
Background The bicaval drainage under veno-venous extracorporeal membrane oxygenation (VV ECMO) was compared in present experimental study to the inferior caval drainage in terms of systemic oxygenation. Method Two mathematical models were built to simulate the inferior vena cava-to-right atrium (IVC → RA) route and the bicaval drainage-to-right atrium return (IVC + SVC → RA) route using the following parameters: cardiac output (QC), IVC flow/QC ratio, venous oxygen saturation, extracorporeal pump flow (QEC), and pulmonary shunt (PULM-Shunt) to obtain pulmonary artery oxygen saturation (SPAO2) and systemic blood oxygen saturation (SaO2). Results With the IVC → RA route, SPAO2 and SaO2 increased linearly with QEC/QC until the threshold of the IVC flow/QC ratio, beyond which the increase in SPAO2 reached a plateau. With the IVC + SVC → RA route, SPAO2 and SaO2 increased linearly with QEC/QC until 100% with QEC/QC = 1. The difference in required QEC/QC between the two routes was all the higher as SaO2 target or PULM-Shunt were high, and occurred all the earlier as PULM-Shunt were high. The required QEC between the two routes could differ from 1.0 L/min (QC = 5 L/min) to 1.5 L/min (QC = 8 L/min) for SaO2 target = 90%. Corresponding differences of QEC for SaO2 target = 94% were 4.7 L/min and 7.9 L/min, respectively. Conclusion Bicaval drainage under ECMO via the IVC + SVC → RA route gave a superior systemic oxygenation performance when both QEC/QC and pulmonary shunt were high. The VV-V ECMO configuration (IVC + SVC → RA route) might be an attractive rescue strategy in case of refractory hypoxaemia under VV ECMO.
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