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Intra Articular Injection Of Autologous Microfat And Platelet-Rich Plasma In The Treatment Of Knee Osteoarthritis: A Double Blind Randomized Comparative Study
Louis ML, Gravier Dumonceau R, Jouve E, Cohen M, Djouri R, Richardet N, Jourdan E, Giraudo L, Dumoulin C, Grimaud F, et al
Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association. 2021
Abstract
PURPOSE Compare a single abdominal microfat (MF) injection mixed or not with PRP Low Dose (LD) or High Dose (HD) in order to improve MRI parameters and alleviate pain and enhance functional capacity in knee osteoarthritis (OA). METHODS Patients with symptomatic grade 2 to 4 knee OA according to the International Cartilage Repair Society MRI classification were selected. They were prospectively assessed at baseline, at 3 and 6 months of follow-up. The primary endpoint was the change in maximum of value of cartilage relaxation time in T2 mapping sequences (T2max) at 3 months. Secondary endpoints were MRI grade severity and joint space assessment, WOMAC score, pain evaluation, knee range of motion and patient's satisfaction. Adverse events were also collected. The complete cell counts and growth factors content of injected products were assessed to analyze their potential relationship with MRI/clinical outcomes. RESULTS Three groups of 10 patients received a single injection of 10 cc of a mix (1:1) containing either MF-Saline, MF-PRP LD or MF-PRP HD. T2max did not change significantly over the time for any of the groups. All treatments significantly improved knee functional status and symptoms relief at 3 and 6 months. All patients were responders in the MF/PRP HD at 3 months and significantly higher compared to MF/PRP LD. Half of the injected PRP in the MF/PRP LD group displayed RBCs contamination over 8% which was correlated with an impairment of T2max. CONCLUSION A single intra articular injection of MF with or without PRP is safe and may offer a significant clinical improvement in patients with OA.
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Blood transfusion and ischaemic outcomes according to anemia and bleeding in patients with non-ST-segment elevation acute coronary syndromes: Insights from the TAO randomized clinical trial
Deharo P, Ducrocq G, Bode C, Cohen M, Cuisset T, Mehta SR, Pollack CV, Wiviott SD, Rao SV, Jukema JW, et al
Int J Cardiol. 2020
Abstract
BACKGROUND The benefits and risks of blood transfusion in patients with acute myocardial infarction who are anemic or who experience bleeding are debated. We sought to study the association between blood transfusion and ischemic outcomes according to haemoglobin nadir and bleeding status in patients with NST-elevation myocardial infarction (NSTEMI). METHODS The TAO trial randomized patients with NSTEMI and coronary angiogram scheduled within 72h to heparin plus eptifibatide versus otamixaban. After exclusion of patients who underwent coronary artery bypass surgery, patients were categorized according to transfusion status considering transfusion as a time-varying covariate. The primary ischemic outcome was the composite of all-cause death or MI within 180 days of randomization. Subgroup analyses were performed according to pre-transfusion hemoglobin nadir and bleeding status. RESULTS 12,547 patients were enrolled. Among these, blood transfusion was used in 489 (3.9%) patients. Patients who received transfusion had a higher rate of death or MI (29.9% vs. 8.1%, p<0.01). This excess risk persisted after adjustment on GRACE score and nadir of hemoglobin (HR 3.36 95%CI 2.63-4.29 p<0.01). Subgroup analyses showed that blood transfusion was associated with a higher risk in patients without overt bleeding (adjusted HR 6.25 vs. 2.85; p-interaction 0.001) as well as in those with hemoglobin nadir > 9.0 g/dl (HR 4.01; p-interaction<0.0001). CONCLUSION In patients with NSTEMI, blood transfusion was associated with an overall increased risk of ischaemic events. However, this was mainly driven by patients without overt bleeding and those hemoglobin nadir > 9.0g/dl. This suggests possible harm of transfusion in those groups.
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Dynamic Impact of Transfusion Ratios on Outcomes in Severely Injured Patients: Targeted Machine Learning Analysis of the PROPPR Randomized Clinical Trial
Nguyen M, Pirracchio R, Kornblith LZ, Callcut R, Fox EE, Wade CE, Schreiber M, Holcomb JB, Coyle J, Cohen M, et al
J Trauma Acute Care Surg. 2020
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Abstract
BACKGROUND Massive transfusion protocols to treat post-injury hemorrhage are based on pre-defined blood product transfusion ratios followed by goal-directed transfusion based on patient's clinical evolution. However, it remains unclear how these transfusion ratios impact patient outcomes over time from injury. METHODS The Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) is a phase 3, randomized controlled trial, across 12 level-I trauma centers in North America. From 2012 to 2013, 680 severely injured patients required massive transfusion. We used semi-parametric machine learning techniques and causal inference methods to augment the intent-to-treat analysis of PROPPR, estimating the dynamic relationship between transfusion ratios and outcomes: mortality and hemostasis at different time-points during the first 24 hours after admission. RESULTS In the intention-to-treat analysis, the 1:1:1 group tended to have decreased mortality, but with no statistical significance. For patients in whom hemostasis took longer than 2 hours, the 1:1:1 ratio was associated with a higher probability of hemostasis, statistically significant from the 4 hour on. In the per-protocol, actual-transfusion-ratios-received analysis, during four successive time intervals, no significant association was found between the actual ratios and mortality. When comparing patient groups who received both high plasma:PRBC and high platelet:PRBC ratios to the group of low ratios in both, the relative risk of achieving hemostasis was 2.49 (95% CI = 1.19-5.22) during the 3 hour after admission, suggesting a significant beneficial impact of higher transfusion ratios of plasma and platelets on hemostasis. CONCLUSIONS Our results suggest that the impact of transfusion ratios on hemostasis is dynamic. Overall, the transfusion ratios had no significant impact on mortality over time. However, receiving higher ratios of platelets and plasma relative to red blood cells hastens hemostasis in subjects who have yet to achieve hemostasis within 3 hours after hospital admission. LEVEL OF EVIDENCE Prognostic, level III.
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A comparison of resuscitation intensity (RI) and critical administration threshold (CAT) in predicting early mortality among bleeding patients: a multicenter validation in 680 major transfusion patients
Meyer DE, Cotton BA, Fox EE, Stein D, Holcomb JB, Cohen M, Inaba K, Rahbar E
The Journal of Trauma and Acute Care Surgery. 2018;85((4):):691-696
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Abstract
BACKGROUND To address deficiencies associated with the classic definition of massive transfusion, Critical Administration Threshold and Resuscitation Intensity were developed to better quantify the overall severity of illness and predict the need for transfusions and early mortality. We sought to evaluate these as more appropriate replacements for MT in defining mortality risk in patients undergoing major transfusions. METHODS Patients predicted to receive MT at 12 Level-1 trauma centers were randomized in the PROPPR trial. MT: ≥10U RBC in 24 hours; CAT+: ≥3U RBC in the first hour; and RI: total products in the first 30 minutes (1U RBC, 1U plasma, 1000mL crystalloid, 500mL colloid each valued at 1U). RI was evaluated as a continuous variable and dichotomized as RI4+, where RI≥4 U. Each metric was evaluated for its ability to predict mortality at 3, 6, and 24 hours, and at 30 days. RESULTS Of the 680 patients, 301 patients met MT definition, 521 were CAT+, and 445 were RI4+. Of those that died, 23% never reached MT threshold, but all were captured by CAT+ and RI4+. The 3-hr (9 vs. 9%), 6-hr (14 vs. 14%), 24-hr (17 vs. 18%), and 30-day mortality rates (28 vs. 29%) were similar between CAT+ and RI4+ patients. When RI was evaluated as a continuous variable, each unit increase was associated with a 20% increase in hemorrhage-related mortality (OR 1.20, 95% CI [1.15-1.29], p<0.05).CONCLUSIONBoth RI and CAT are valid surrogates for early mortality in patients undergoing major transfusion, capturing patients omitted by the MT definition. CAT+ showed the best sensitivity; RI4+ demonstrated better specificity and good PPV and NPV. While CAT+ may be suited for patients receiving a RBC-dominant resuscitation, RI4+ is more comprehensive. RI can also be used as a continuous variable to provide quantitative as well qualitative risk of death.LEVEL OF EVIDENCELevel III, Prognostic.