| Study characteristics |
| Methods |
Trial design: retrospective matched controlled study
Type of publication: journal online, ahead of print
Setting: ICU
Recruitment dates: NR
Country: China
Language: English
Number of centres: 2
Trial registration number: NR
Date of trial registration: NR
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| Participants |
Age: median 61.5 years in CP group, median 73 years in control group
Gender: 5 male, 1 female in CP group; 11 males, 4 females in control group
Ethnicity: NR
Number of participants (recruited/allocated/evaluated): 21 (6 received CP, 15 in control group)
Severity of disease: critical (admitted to ICU)
Co‐morbidities: pregnancy, diabetes, hypertension, cardiovascular disease (CP group)
Inclusion criteria: critically ill patients
Exclusion criteria: NR
Previous treatments (e.g. experimental drug therapies, oxygen therapy, ventilation): antibiotics (100%), antiviral therapy (67%), traditional Chinese medicine (50%), IVIG (83%), steroid therapy (67%), high‐flow oxygen therapy (100%), mechanical ventilation (83%), renal replacement therapy (33%), ECMO (67%) in the CP group
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| Interventions |
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Details of donors:
Treatment details, including time of plasma therapy (e.g. early stage of disease): critically ill patients
Comparator: Not applicable
Concomitant therapy: antibiotics (100%), antiviral therapy (67%), traditional Chinese medicine (50%), IVIG (83%), steroid therapy (67%), high‐flow oxygen therapy (100%), mechanical ventilation (83%), renal replacement therapy (33%), ECMO (67%) in the CP group. Unclear whether these treatments were stopped before plasma transfusion or continuously given
Duration of follow‐up: NR
Treatment cross‐overs: Not applicable
Compliance with assigned treatment: good (all compliant)
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| Outcomes |
Primary study outcome(s): survival
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Primary review outcomes
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Secondary review outcomes
Number of participants with grade 3 and grade 4 AEs, including potential relationship between intervention and adverse reaction (e.g. TRALI, transfusion‐transmitted infection, TACO, TAD, acute transfusion reactions): none
Number of participants with SAEs: none
Improvement of clinical symptoms, assessed through need for respiratory support at up to 7 days; 8‐15 days; 16‐30 days: NR
30‐day and 90‐day mortality: reported
Admission on the ICU: reported (all admitted)
Length of stay on the ICU: NR
Time to discharge from hospital: reported (1 discharged)
QoL: NR
Additional study outcomes: duration of viral shedding
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| Notes |
Sponsor/funding: supported by The National Natural Science Foundation of China (No. 81970517), Zhongyuan (Henan) Thousands Outstanding Talents Plan (No. ZYQR201912179), Foundation for Distinguished Young Talents of Zhengzhou University Medical School (No.2020ZQLMS), and The Key Scientific Research Project of Henan Higher Education Institutions of China (No. 20B320028).
COIs: the authors have no potential conflicts of interest to disclose.
Other: written informed consents were obtained from all the family members of patients who received plasma.
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