Validation of a Prognostic Score to Identify Hospitalized Patients with COVID-19 at Increased Risk for Bleeding
Abstract
:1. Introduction
2. Methods
2.1. Patients
2.2. Study Design
2.3. Variables of Interest
2.4. Statistical Analysis
3. Results
4. Discussion
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
Appendix A
References
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N | Standard Doses | Intermediate Doses | Therapeutic Doses | Other Drugs | |
---|---|---|---|---|---|
Patients, N | 972 | 280 | 412 | 157 | 123 |
Clinical characteristics, | |||||
Male gender | 613 (63%) | 173 (62%) | 257 (62%) | 112 (71%) * | 71 (58%) |
Age <70 years | 562 (58%) | 142 (51%) | 266 (65%) ‡ | 98 (62%) * | 56 (46%) |
Body weight <70 kg | 157 (22%) | 54 (27%) | 73 (25%) | 16 (13%) † | 14 (17%) |
Admitted in ICUs | 464 (48%) | 136 (49%) | 177 (43%) | 91 (58%) | 60 (50%) |
Recent major bleeding | 10 (1.0%) | 2 (0.7%) | 5 (1.2%) | 1 (0.6%) | 2 (1.7%) |
Blood tests, | |||||
Anemia | 287 (30%) | 84 (30%) | 106 (26%) | 45 (29%) | 52 (42%) * |
Platelet count <100,000/μL | 51 (5.3%) | 15 (5.4%) | 13 (3.2%) | 6 (3.8%) | 17 (14%) † |
Fibrinogen <1000 mg/dL | 813 (89%) | 234 (91%) | 342 (87%) | 134 (88%) | 103 (95%) |
Prothrombin time > 13.5 s | 360 (38%) | 88 (32%) | 126 (31%) | 61 (41%) | 85 (73%) ‡ |
D-dimer > upper normal limit | 845 (90%) | 254 (93%) | 362 (91%) | 137 (91%) | 92 (79%) ‡ |
D-dimer >10 × upper limit | 336 (36%) | 93 (34%) | 130 (33%) | 72 (48%) † | 41 (35%) |
Ferritin >500 ng/mL (N = 809) | 569 (70%) | 169 (70%) | 242 (69%) | 99 (74%) | 59 (68%) |
CrCl < 60 mL/min | 460 (47%) | 143 (51%) | 177 (43%) * | 53 (34%) ‡ | 87 (71%) ‡ |
Concomitant therapies, | |||||
Antiplatelet drugs | 144 (15%) | 39 (14%) | 57 (14%) | 18 (11%) | 30 (25%) † |
VTE prophylaxis, | |||||
Duration (median days, IQR) | 14.7 ± 10.3 | 15.7 ± 10.5 | 14.9 ± 10.1 | 14.9 ± 10.4 | 11.8 ± 9.7 ‡ |
Prognostic score, | |||||
Very low risk | 203 (21%) | 55 (20%) | 111 (27%) * | 0 | 37 (30%) * |
Low risk | 285 (29%) | 96 (34%) | 124 (30%) | 34 (22%) † | 31 (25%) |
Intermediate risk | 263 (27%) | 85 (30%) | 106 (26%) | 36 (23%) | 36 (29%) |
High risk | 221 (23%) | 44 (16%) | 71 (17%) | 87 (55%) ‡ | 19 (15%) |
Outcomes, | |||||
Non-major bleeding | 67 (6.9%) | 21 (7.5%) | 23 (5.6%) | 15 (9.6%) | 8 (6.5%) |
Major bleeding | 65 (6.7%) | 18 (6.4%) | 21 (5.1%) | 11 (7.0%) | 15 (12%) |
Bleeding-related death | 30 (3.1%) | 7 (2.5%) | 10 (2.4%) | 5 (3.2%) | 8 (6.5%) |
All-cause mortality, | |||||
Yes | 230 (24%) | 53 (19%) | 79 (19%) | 46 (29%) * | 52 (43%) ‡ |
Major Bleeding | Non-Major Bleeding | No Bleeding | All Patients | |
---|---|---|---|---|
Patients, N | 65 | 67 | 840 | 972 |
Clinical characteristics, | ||||
Male gender | 47 (72%) | 45 (67%) | 521 (62%) | 613 (63%) |
Age <70 years | 37 (57%) | 46 (69%) | 479 (57%) | 562 (58%) |
Body weight <70 kg | 7 (13%) | 11 (22%) | 139 (23%) | 157 (22%) |
Admitted in ICUs | 54 (83%) ‡ | 59 (88%) ‡ | 351 (42%) | 464 (48%) |
Recent major bleeding | 0 | 1 (1.5%) | 9 (1.1%) | 10 (1.0%) |
Blood tests, | ||||
Anemia | 17 (26%) | 28 (42%) * | 242 (29%) | 287 (30%) |
Platelet count <100,000/μL | 4 (6.2%) | 4 (6.0%) | 43 (5.1%) | 51 (5.3%) |
Fibrinogen <1000 mg/dL | 52 (84%) | 55 (89%) | 706 (90%) | 813 (89%) |
Prothrombin time >13.5 s | 21 (32%) | 22 (33%) | 317 (39%) | 360 (38%) |
D-dimer > upper normal limit | 63 (98%) † | 62 (97%) | 720 (89%) | 845 (90%) |
D-dimer >10 × upper limit | 46 (72%) ‡ | 37 (58%) ‡ | 253 (31%) | 336 (36%) |
Ferritin >500 ng/mL (N = 809) | 48 (84%) † | 53 (80%) * | 463 (67%) | 564 (70%) |
CrCl <60 mL/min | 33 (51%) | 27 (40%) | 400 (48%) | 460 (47%) |
Concomitant therapies, | ||||
Antiplatelets | 15 (23%) * | 14 (21%) | 115 (14%) | 144 (15%) |
VTE prophylaxis, | ||||
Standard doses | 18 (28%) | 21 (31%) | 241 (29%) | 280 (29%) |
Intermediate doses | 21 (32%) | 23 (34%) | 368 (44%) | 412 (42%) |
Therapeutic doses | 11 (17%) | 15 (22%) | 131 (16%) | 157 (16%) |
Other drugs | 15 (23%) * | 8 (12%) | 100 (12%) | 123 (13%) |
Duration (median days, IQR) | 16 (10–26) | 15 (10–23) | 12 (7–18) | 12 (7–19) |
Duration (>10 days) | 46 (71%) * | 48 (72%) * | 473 (56%) | 567 (58%) |
30-day mortality, | ||||
Yes | 30 (46%) ‡ | 22 (33%) * | 178 (21%) | 230 (24%) |
Major Bleeding | Bleeding-Related Death | Non-Major Bleeding | All Patients | |
---|---|---|---|---|
Patients, N | 65 | 30 | 67 | 132 |
Orotracheal | 14 (22%) | 8 (27%) | 15 (22%) | 29 (22%) |
Gastrointestinal | 18 (28%) | 7 (23%) | 7 (10%) | 25 (19%) |
Hematoma | 10 (15%) | 5 (17%) | 7 (10%) | 17 (13%) |
Genitourinary | 4 (6.2%) | 1 (3.3%) | 4 (6.0%) | 8 (6.1%) |
Alveolar | 4 (6.2%) | 1 (3.3%) | 4 (6.0%) | 8 (6.1%) |
Abdominal | 5 (7.7%) | 1 (3.3%) | 0 | 5 (3.8%) |
Muscular | 4 (6.2%) | 1 (3.3%) | 1 (1.5%) | 5 (3.8%) |
Intracranial | 3 (4.6%) | 1 (3.3%) | 0 | 3 (2.3%) |
Other | 3 (4.6%) | 5 (17%) | 29 (43%) | 32 (24%) |
Patients, N | Major Bleeding | Non-Major Bleeding | Bleeding-Related Death | |
---|---|---|---|---|
Estimated risk | ||||
All patients | 972 | 65 (6.7%) | 67 (6.9%) | 30 (3.09%) |
Very low risk (0 points) | 203 | 2 (1.0%) | 1 (0.5%) | 0 |
Low risk (1 point) | 285 | 6 (2.1%) | 10 (3.5%) | 1 (0.35%) |
Intermediate risk (2 points) | 263 | 23 (8.7%) | 25 (9.5%) | 7 (2.6%) |
High risk (3–4 points) | 221 | 34 (15.4%) | 31 (14.2%) | 22 (9.9%) |
C-statistics (95%CI) | ||||
All patients | 972 | 0.74 (0.68–0.79) | 0.73 (0.67–0.78) | 0.82 (0.76–0.87) |
Standard doses | 280 | 0.72 (0.60–0.84) | 0.72 (0.63–0.82) | 0.85 (0.70–1.00) |
Intermediate doses | 412 | 0.76 (0.68–0.86) | 0.72 (0.63–0.82) | 0.84 (0.76–0.91) |
Therapeutic doses | 157 | 0.66 (0.51–0.80) | 0.76 (0.63–0.88) | 0.79 (0.66–0.92) |
Other drugs | 123 | 0.82 (0.72–0.92) | 0.74 (0.61–0.86) | 0.86 (0.77–0.95) |
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Demelo-Rodriguez, P.; Galeano-Valle, F.; Ordieres-Ortega, L.; Siniscalchi, C.; Martín Del Pozo, M.; Fidalgo, Á.; Gil-Díaz, A.; Lobo, J.L.; De Ancos, C.; Monreal, M.; et al. Validation of a Prognostic Score to Identify Hospitalized Patients with COVID-19 at Increased Risk for Bleeding. Viruses 2021, 13, 2278. https://doi.org/10.3390/v13112278
Demelo-Rodriguez P, Galeano-Valle F, Ordieres-Ortega L, Siniscalchi C, Martín Del Pozo M, Fidalgo Á, Gil-Díaz A, Lobo JL, De Ancos C, Monreal M, et al. Validation of a Prognostic Score to Identify Hospitalized Patients with COVID-19 at Increased Risk for Bleeding. Viruses. 2021; 13(11):2278. https://doi.org/10.3390/v13112278
Chicago/Turabian StyleDemelo-Rodriguez, Pablo, Francisco Galeano-Valle, Lucía Ordieres-Ortega, Carmine Siniscalchi, Mar Martín Del Pozo, Ángeles Fidalgo, Aída Gil-Díaz, José Luis Lobo, Cristina De Ancos, Manuel Monreal, and et al. 2021. "Validation of a Prognostic Score to Identify Hospitalized Patients with COVID-19 at Increased Risk for Bleeding" Viruses 13, no. 11: 2278. https://doi.org/10.3390/v13112278
APA StyleDemelo-Rodriguez, P., Galeano-Valle, F., Ordieres-Ortega, L., Siniscalchi, C., Martín Del Pozo, M., Fidalgo, Á., Gil-Díaz, A., Lobo, J. L., De Ancos, C., Monreal, M., & For the RIETE-Bleeding Investigators. (2021). Validation of a Prognostic Score to Identify Hospitalized Patients with COVID-19 at Increased Risk for Bleeding. Viruses, 13(11), 2278. https://doi.org/10.3390/v13112278