TABLE 2.
Serious adverse events observed at Stanford compared with safety data reported for the first 20,000 patients enrolled in the national EAP 12
| Stanford EAP (n = 30) | Stanford EUA (n = 19) | Total Stanford cohort (n = 49) | National EAP data (reported) (n = 20,000) | Risk difference (RD) g , 95% CI, p value | |
|---|---|---|---|---|---|
| Increased O2 requirement | |||||
| Within 4 h of transfusion a | 6 (20%) | 1 (5%) | 7 (14%) | NR | NR |
| Within 24 h of transfusion b | 11 (37%) | 7 (37%) | 18 (37%) | NR | NR |
| Intubation | |||||
| Within 4 h of transfusion a | 1 (3%) | 0 (0%) | 1 (2%) | NR | NR |
| Within 24 h of transfusion c | 2 (7%) | 1 (5%) | 3 (6%) | NR | NR |
| TACO d | |||||
| Within 4 h of transfusion | 4 (13%) | 2 (11%) | 6 (12%) | 36 (0.18%) |
12.06% [2.89%, 21.24%] p = .010 |
| Within 24 h of transfusion e | 4 (13%) | 2 (11%) | 6 (12%) | NR | NR |
| TRALI d | |||||
| Within 4 h of transfusion | 0 (0%) | 0 (0%) | 0 (0%) | 21 (0.11%) |
−0.11% [−0.15%, −0.06%] p < .0001 |
| Within 24 h of transfusion | 0 (0%) | 0 (0%) | 0 (0%) | NR | NR |
| Severe allergic transfusion reaction d | |||||
| Within 4 h of transfusion | 0 (0%) | 0 (0%) | 0 (0%) | 21 (0.11%) |
−0.11% [−0.15%, −0.06%] p < .0001 |
| Within 24 h of transfusion | 0 (0%) | 0 (0%) | 0 (0%) | NR | NR |
| Serious adverse event within 7 days of transfusion | 3 (10%) | 0 (0%) | 3 (6%) | 113 (0.56%) |
5.56% [−1.16%, 12.3%] p = .105 |
| Thrombotic or thromboembolic complication | 5 (17%) | 0 (0%) | 5 (10%) | 457 (2%) |
7.92% [−0.56%, 16.4%] p = .067 |
| Sustained hypotension | 0 (0%) | 1 (5%) | 1 (2%) | 677 (3%) |
−1.34% [−5.31%, 2.62%] p = .507 |
| Cardiac events | 1 (3%) | 1 (5%) | 2 (4%) | 1806 (9%) |
−4.95% [−10.5%, 0.61%] p = .0808 |
| ICU admission | 3 (10%) | 0 (0%) | 3 (6%) | 113 (0.56%) |
5.56% [−1.16%, 12.27%] p = .105 |
| Mortality | |||||
| Within 4 h of transfusion | 0 (0%) | 0 (0%) | 0 (0%) | 63 (0.3%) |
−0.32% [−0.39%, −0.24%] p < .001 |
| Within 7 days of transfusion f | 0 (0%) | 2 (11%) | 2 (4%) | 2592 (13%) |
−8.88% [−14.44%, −3.32%] p = .0017 |
| Overall | 5 (17%) | 3 (16%) | 8 (16%) | NR | NR |
Abbreviations: CCP, Coronavirus disease 2019 (COVID‐19) convalescent plasma; EAP, Expanded Access Protocol; EUA, Emergency Use Authorization; ICU, intensive care unit; NR, not reported; O2, supplemental oxygen; Related, related to CCP transfusion; TACO, transfusion‐associated cardiac overload; TRALI, transfusion‐related acute lung injury.
Data in this row includes patients with TACO.
Data in this row includes patients with increased O2 requirements within 4 h of transfusion and patients with TACO.
Data in this row includes patients intubated within 4 h of transfusion and patients with TACO.
Diagnosis of TACO, TRALI, and severe allergic transfusion reactions were assigned using CDC/NHSN Hemovigilance definitions for the Stanford cohort. 16
Data in this row includes patients with who developed TACO within 4 h of transfusion.
Data in this row includes patients who died within 4 h of transfusion.
Reference group = national EAP; risk difference (RD) = risk for adverse event (Stanford) ‐ risk for adverse event (National EAP). 12