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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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Effect of red blood cell transfusion on the development of retinopathy of prematurity: A systematic review and meta-analysis
Zhu Z, Hua X, Yu Y, Zhu P, Hong K, Ke Y
PLoS One. 2020;15(6):e0234266
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Abstract
BACKGROUND The effect of red blood cell (RBC) transfusion on retinopathy of prematurity (ROP) is difficult to establish, because ROP may also be influenced by other factors. Therefore, we carried out a systematic review and meta-analysis to explore the relationship between RBC transfusion and the development of ROP. METHODS The PubMed, Embase, Cochrane Library and Web of Science databases were searched from their inception to September 1, 2019. Observational studies that reported the relationship between RBC transfusion and ROP after adjusting for other potential risk factors were included. The combined result was analyzed by a random effect model. Heterogeneity and publication bias were tested, and sensitivity analysis was performed. RESULTS Of the 2628 identified records, 18 studies including 15072 preterm infants and 5620 cases of ROP were included. A random effect model was used and revealed that RBC transfusion was significantly associated with ROP (pooled OR = 1.50, 95% CI: 1.27-1.76), with moderate heterogeneity among the included studies (I2 = 44.2%). Subgroup analysis indicated that RBC transfusion was more closely related to ROP in the group with a gestational age (GA) ≤32 weeks (OR = 1.77, 95% CI: 1.29-2.43) but not in the groups with a GA ≤34 weeks (OR = 1.36, 95% CI: 0.85-2.18) or a GA <37 weeks (OR = 1.25, 95% CI: 0.86-1.82). No obvious publication bias was found based on the funnel plot and Egger's test. Removing any single study did not significantly alter the combined result in the sensitivity analysis. CONCLUSIONS Our study revealed that RBC transfusion is an independent risk factor for the development of ROP, especially in younger preterm infants. However, there seemed to be no evidence to support an effect of RBC transfusion on ROP in older groups. Further studies addressing this issue in older preterm neonates are warranted.
PICO Summary
Population
Preterm infants (18 studies, n= 15072).
Intervention
Received red blood cell (RBC) transfusion.
Comparison
Did not receive RBC.
Outcome
A random effect model revealed that RBC transfusion was significantly associated with retinopathy of prematurity (ROP), with moderate heterogeneity among the included studies (I2= 44.2%). Subgroup analysis indicated that RBC transfusion was more closely related to ROP in the group with a gestational age (GA) </=32 weeks but not in the groups with a GA </=34 weeks or a GA <37 weeks.
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Impact of warming blood transfusion and infusion toward cerebral oxygen metabolism and cognitive recovery in the perioperative period of elderly knee replacement
Wei C, Yu Y, Chen Y, Wei Y, Ni X
Journal of Orthopaedic Surgery. 9:8, 2014.. 2014;9((8):)
Abstract
OBJECTIVE This study aims to observe the impact of the temperature of blood transfusion and infusion toward the perioperative cerebral oxygen metabolism and the postoperative cognitive recovery. METHODS Eighty patients of knee replacement under epidural and general anesthesia were randomly divided into warming blood transfusion and infusion (WBI) group (n=40) and control group (n=40). The changes of nasopharyngeal temperature, middle cerebral artery blood flow, CERO2, and SjVO2 of the two groups were recorded at each time point for the assessment of the postoperative overall quality of recovery and cognitive recovery situation. RESULTS The nasopharyngeal temperatures of the two groups at different time points after transfusion were significantly lower than that at T1, and there was a significant difference between the two groups (P<0.05). The CERO2 values of the two groups at T3 were significantly higher than at T1, while the SjVO2 values were significantly decreased (P<0.01). CONCLUSION The WBI can significantly reduce the occurrence of the perioperative hypothermia, while it has no significant effect toward cerebral oxygen metabolism, postoperative overall recovery, and recovery of cognitive function.