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Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19: A Randomized Clinical Trial
Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, Kong Y, Ren L, Wei Q, Mei H, et al
Jama. 2020
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Abstract
Importance: Convalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed. Objective: To evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19. Design, Setting, and Participants: Open-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020. The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation). The trial was terminated early after 103 of a planned 200 patients were enrolled. Intervention: Convalescent plasma in addition to standard treatment (n = 52) vs standard treatment alone (control) (n = 51), stratified by disease severity. Main Outcomes and Measures: Primary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]). Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours. Results: Of 103 patients who were randomized (median age, 70 years; 60 [58.3%] male), 101 (98.1%) completed the trial. Clinical improvement occurred within 28 days in 51.9% (27/52) of the convalescent plasma group vs 43.1% (22/51) in the control group (difference, 8.8% [95% CI, -10.4% to 28.0%]; hazard ratio [HR], 1.40 [95% CI, 0.79-2.49]; P = .26). Among those with severe disease, the primary outcome occurred in 91.3% (21/23) of the convalescent plasma group vs 68.2% (15/22) of the control group (HR, 2.15 [95% CI, 1.07-4.32]; P = .03); among those with life-threatening disease the primary outcome occurred in 20.7% (6/29) of the convalescent plasma group vs 24.1% (7/29) of the control group (HR, 0.88 [95% CI, 0.30-2.63]; P = .83) (P for interaction = .17). There was no significant difference in 28-day mortality (15.7% vs 24.0%; OR, 0.65 [95% CI, 0.29-1.46]; P = .30) or time from randomization to discharge (51.0% vs 36.0% discharged by day 28; HR, 1.61 [95% CI, 0.88-2.93]; P = .12). Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87.2% of the convalescent plasma group vs 37.5% of the control group (OR, 11.39 [95% CI, 3.91-33.18]; P < .001). Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care. Conclusion and Relevance: Among patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days. Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference. Trial Registration: Chinese Clinical Trial Registry: ChiCTR2000029757.
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Effect of Convalescent Plasma Therapy on Time to Clinical Improvement in Patients With Severe and Life-threatening COVID-19
Li L, Zhang W, Hu Y, Tong X, Zheng S, Yang J, Kong Y, Ren L, Wei Q, Mei H, et al
Jama. 2020
Abstract
ImportanceConvalescent plasma is a potential therapeutic option for patients with coronavirus disease 2019 (COVID-19), but further data from randomized clinical trials are needed ObjectiveTo evaluate the efficacy and adverse effects of convalescent plasma therapy for patients with COVID-19 Design, Setting, and ParticipantsOpen-label, multicenter, randomized clinical trial performed in 7 medical centers in Wuhan, China, from February 14, 2020, to April 1, 2020, with final follow-up April 28, 2020 The trial included 103 participants with laboratory-confirmed COVID-19 that was severe (respiratory distress and/or hypoxemia) or life-threatening (shock, organ failure, or requiring mechanical ventilation) The trial was terminated early after 103 of a planned 200 patients were enrolled InterventionConvalescent plasma in addition to standard treatment (n = 52) vs standard treatment alone (control) (n = 51), stratified by disease severity Main Outcomes and MeasuresPrimary outcome was time to clinical improvement within 28 days, defined as patient discharged alive or reduction of 2 points on a 6-point disease severity scale (ranging from 1 [discharge] to 6 [death]) Secondary outcomes included 28-day mortality, time to discharge, and the rate of viral polymerase chain reaction (PCR) results turned from positive at baseline to negative at up to 72 hours ResultsOf 103 patients who were randomized (median age, 70 years;60 [58 3%] male), 101 (98 1%) completed the trial Clinical improvement occurred within 28 days in 51 9% (27/52) of the convalescent plasma group vs 43 1% (22/51) in the control group (difference, 8 8% [95% CI, −10 4% to 28 0%];hazard ratio [HR], 1 40 [95% CI, 0 79-2 49];P = 26) Among those with severe disease, the primary outcome occurred in 91 3% (21/23) of the convalescent plasma group vs 68 2% (15/22) of the control group (HR, 2 15 [95% CI, 1 07-4 32];P = 03);among those with life-threatening disease the primary outcome occurred in 20 7% (6/29) of the convalescent plasma group vs 24 1% (7/29) of the control group (HR, 0 88 [95% CI, 0 30-2 63];P = 83) (Pfor interaction = 17) There was no significant difference in 28-day mortality (15 7% vs 24 0%;OR, 0 65 [95% CI, 0 29-1 46];P = 30) or time from randomization to discharge (51 0% vs 36 0% discharged by day 28;HR, 1 61 [95% CI, 0 88-2 93];P = 12) Convalescent plasma treatment was associated with a negative conversion rate of viral PCR at 72 hours in 87 2% of the convalescent plasma group vs 37 5% of the control group (OR, 11 39 [95% CI, 3 91-33 18];P < 001) Two patients in the convalescent plasma group experienced adverse events within hours after transfusion that improved with supportive care Conclusion and RelevanceAmong patients with severe or life-threatening COVID-19, convalescent plasma therapy added to standard treatment, compared with standard treatment alone, did not result in a statistically significant improvement in time to clinical improvement within 28 days Interpretation is limited by early termination of the trial, which may have been underpowered to detect a clinically important difference Trial RegistrationChinese Clinical Trial Registry:ChiCTR2000029757
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Appropriateness of red blood cell use in China in the last thirteen years: A systematic review
Kong Y, Wang X, Yin Y, Tian X, Li L, Wang J, Tian L, Song N, Liu Z
Heliyon. 2019;5(3):e01408
Abstract
Objective: To determine both the rates of appropriate red blood cells (RBCs) use in China and where inappropriate use is particularly prevalent. Background: In China, obtaining the comprehensive picture in unnecessary RBCs transfusion is helpful for understanding the strained blood supplies and targeting training of clinicians. Study design: and methods: Eligible studies were mainly retrieved from four Chinese medical databases and four databases from abroad. In all studies, the appropriateness of RBCs transfusion in transfusion cases, blood request forms, or RBC units within the last thirteen years was determined by using national guidelines. Relationships between RBCs-transfusion appropriateness and type of RBCs-transfusion record, geographical region, level of hospital (LOH-2 and LOH-3), department type (operative vs. non-operative), and study quality (high vs. low) were analyzed by Chi-squared tests. Results: On average, 72.30% (standard deviation, SD = 18.87%) of all cases/forms/units throughout China were appropriate. The appropriateness of RBCs-transfusion differed significantly depending on RBCs-transfusion record type, they were 69.10%, 68.85%, and 75.64% for blood request forms, transfusion cases, and RBCs units, respectively (p < 0.001). The southwest and northeast were the most (80.62%) and the least (66.57%) appropriate transfusion areas, respectively. The coefficients of variances (CV) for the geographical regions differed significantly (0.029-0.39). LOH-3 were more appropriate than LOH-2 (p < 0.001). Non-operative departments were more appropriate than operative departments (p < 0.001). High-quality studies reported higher appropriate rate than low-quality studies (74.48% vs. 69.72%, p < 0.001). Conclusion: In China, unnecessary RBCs transfusion was common and may exacerbate the current pressure on blood supplies. Clinicians in certain geographical regions, LOH-2, and operative departments should be targeted with training in transfusion medicine.
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Blood transfusion and risk of atrial fibrillation after coronary artery bypass graft surgery: A meta-analysis of cohort studies
Liu S, Li Z, Liu Z, Hu Z, Zheng G
Medicine. 2018;97((10))
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Abstract
The aim of this study was to systematically evaluate the effect of blood transfusion (BT) on postoperative atrial fibrillation (AF) in adult patients who had undergone coronary artery bypass grafting (CABG) surgery.PubMed, Embase, and Cochrane Library databases from inception to January 2017 were searched. Cohort studies were searched that evaluated the association between BT and the risk of postoperative AF in adult patients who had undergone CABG surgery. Study quality was assessed by using the Newcastle-Ottawa scale (NOS). A meta-analysis was performed with the random-effect model.Eight cohort studies involving 7401 AF cases and 31,069 participants were identified and included in our data analysis. The pooled odds ratio of postoperative AF in patients with BT was 1.45 (95% confidence interval, 1.26-1.67), with significant heterogeneity (P < .0001, I = 79%). Excluding one study that had an off-pump CABG did not significantly impact this result (odds ratio, 1.36; 95% confidence interval, 1.23-1.50; n = 7). To examine the stability of the primary results, we performed subgroup analyses. The association between BT and the risk of postoperative AF was similar, as determined in the stratified analyses conducted according to study design, type of surgery, and country.The findings of the present meta-analysis demonstrated a statistically significant increase in postoperative AF risk among adult patients with BT. Further prospective large-scale studies are needed to establish causality and to elucidate the underlying mechanisms.