Table 1. Baseline population characteristics and laboratory results.
| Variables | All patients | WHO bleeding grade | |||
|---|---|---|---|---|---|
| Grade 0 | Grade 1 | Grade ≥ 2 | P value‡ | ||
| N (%) | 126 (100) | 33 (26.2) | 66 (52.4) | 27 (21.4) | |
| Age, yr (range) | 55 (15–93) | 57 (19–81) | 54 (18–81) | 54 (15–93) | 0.807 |
| Female/male (%female) | 65/61 (51.6) | 11/22 (33.3) | 32/34 (48.5) | 22/5 (81.5)† | < 0.001 |
| Diagnosis (%) | 0.324 | ||||
| Thrombocytopenia§ | 62 (49.2) | 19 (57.6) | 32 (48.5) | 11 (40.7) | |
| Aplastic anemia | 20 (15.9) | 2 (6.1) | 11 (16.7) | 7 (25.9) | |
| Hematologic malignancies|| | 44 (34.9) | 12 (36.4) | 23 (34.8) | 9 (33.3) | |
| WBC ( × 109/L) | 4.78 (0.35–154.64) | 5.44 (0.61–97.49) | 4.85 (0.98–117.10) | 3.30 (0.35–154.64) | 0.249 |
| Hemoglobin (g/dL) | 11.0 (4.8–17.7) | 11.0 (4.8–16.3) | 12.1 (5.5–17.7) | 10.2 (6.4–15.0) | 0.438 |
| Platelets ( × 109/L) | 43 (2–345) | 59 (4–345) | 42 (2–250)* | 18 (3–93)† | < 0.001 |
| Patients with platelet ≤ 130 × 109/L, N (%) | 116 (92.1) | 27 (81.8) | 62 (93.9) | 27 (100.0)* | 0.025 |
| Patients with platelet ≤ 50 × 109/L, N (%) | 76 (60.3) | 14 (42.4) | 40 (60.6) | 22 (81.5)* | 0.009 |
| Patients with platelet ≤ 20 × 109/L, N (%) | 31 (24.6) | 3 (9.1) | 12 (18.2) | 16 (59.3)† | < 0.001 |
| Patients with platelet ≤ 10 × 109/L, N (%) | 13 (10.3) | 1 (3.0) | 5 (7.6) | 7 (25.9)* | 0.009 |
| PT (sec) | 11.3 (9.4–18.0) | 10.8 (9.5–16.7) | 11.6 (9.4–18.0) | 11.1 (9.8–16.9) | 0.04 |
| aPTT (sec) | 31.2 (25.1–45.3) | 32.2 (25.7–45.3) | 30.4 (25.2–41.8) | 31.2 (25.1–41.3) | 0.591 |
| Fibrinogen (mg/dL) | 265.2 (47.4–739.7) | 285.3 (145.2–708.0) | 252.6 (47.4–739.7) | 265.8 (176.9–492.6) | 0.118 |
| FII (%) | 93.3 (21.1–157.7) | 96.4 (32.1–147.9) | 93.3 (41.6–157.7) | 92.4 (63.5–135.3) | 0.927 |
| FV (%) | 107.5 (35.3–305.2) | 121.7 (52.8–240.7) | 101.5 (35.3–202.1) | 107.9 (43.3–305.2) | 0.086 |
| FVII (%) | 94.4 (26.8–176.2) | 96.7 (39.0–134.5) | 93.3 (26.8–176.2) | 95.3 (38.2–148.8) | 0.601 |
| FVIII (%) | 117.5 (58.4–249.5) | 133.9 (62.5–200.9) | 110.9 (58.4–249.5) | 108.9 (69.2–163.4) | 0.079 |
| FIX (%) | 114.6 (48.7–341.1) | 121.8 (48.7–150.7) | 113.6 (48.7–341.1) | 111.8 (51.1–185.9) | 0.233 |
| FX (%) | 90.5 (29.0–158.5) | 93.3 (29.0–131.4) | 88.4 (40.6–158.5) | 88.7 (57.3–136.8) | 0.488 |
| FXI (%) | 88.8 (19.3–217.6) | 93.3 (37.3–130.8) | 88.4 (19.3–217.6) | 87.1 (63.3–135.9) | 0.557 |
| FXII (%) | 70.2 (25.1–199.4) | 67.3 (25.1–163.4) | 68.8 (27.7–199.4) | 71.1 (25.4–153.7) | 0.956 |
| AT (%) | 90.1 (19.7–146.9) | 97.6 (37.4–121.9) | 91.4 (19.7–141.2) | 92.5 (56.1–146.9) | 0.904 |
| Protein C (%) | 101.6 (33.3–209.3) | 104.0 (55.6–155.2) | 102.6 (33.2–168.9) | 99.2 (57.9–209.3) | 0.943 |
| Protein S (%) | 88.4 (23.4–179.8) | 88.4 (39.5–138.2) | 88.7 (23.4–179.8) | 86.4 (57.3–125.4) | 0.926 |
| Plasminogen (%) | 92.4 (25.4–142.0) | 92.7 (55.0–119.4) | 93.9 (34.5–129.7) | 92.4 (25.4–142.0) | 0.737 |
| D-dimer (IU/mL) | 0.24 (0–28.15) | 0.23 (0.04–22.65) | 0.25 (0–28.15) | 0.30 (0.03–4.98) | 0.533 |
| Thromboelastography | |||||
| Reaction time, R (min) | 6.2 (2.1–11.2) | 6.0 (3.6–9.7) | 5.8 (2.3–11.2) | 7.0 (2.1–10.2) | 0.19 |
| Coagulation time, K (min) | 2.6 (0.8–13.9) | 2.2 (0.8–13.9) | 2.6 (1.0–13.8) | 3.5 (1.1–8.9) | 0.003 |
| Angle, α (degree) | 57.4 (16.7–81.3) | 60.8 (20.8–81.3) | 58.5 ((16.7–74.7) | 53.8 (36.8–74.4) | 0.234 |
| MA (mm Hg) | 47.2 (6.2–78.0) | 52.9 (6.2–78.0) | 48.1 (17.4–76.7) | 39.8 (19.2–67.1)† | 0.001 |
| LY30 (%) | 0 (0–2.4) | 0 (0–1.0) | 0 (0–2.4) | 0 (0–1.9) | 0.27 |
| CI (mm) | −2.6 (−11.7–4.1) | −1.2 (−11.7–4.1) | −2.4 (−11.5–3.9) | −4.3 (−9.4–3.8)* | 0.006 |
| Thrombin generation assay | |||||
| Lag time (min) | 4.7 (1.8–15.6) | 4.7 (2.0–11.9) | 4.9 (1.8–12.9) | 4.9 (2.8–15.6) | 0.772 |
| Time to peak (min) | 9.0 (3.7–18.9) | 8.2 (3.7–16.7) | 9.1 (3.9–16.9) | 9.7 (5.9–18.9) | 0.426 |
| ETP (nM-min) | 554.6 (85.1–1,962.8) | 685.5 (145.2–1,962.8) | 542.6 (85.1–1,282.5)* | 502.0 (138.9–954.6)† | 0.011 |
Most of the continuous variables did not show normal distributions except FX, AT and MA; therefore, continuous variables are presented as median (range) and number (percentage) for continuous and categorical variables, respectively.
*P<0.05; †P<0.005; P values were obtained from the comparison of patients with WHO bleeding grade of 1 or ≥2 with those with WHO bleeding grade of 0 by using Mann-Whitney U and χ2 test for quantitative and categorical variables, respectively, with Bonferroni correction for multiple testing; ‡P value: Kruskal-Wallis analysis for continuous variables; §Thrombocytopenia included immune thrombocytopenia (n=35) and thrombocytopenia due to peripheral consumption (n=27); ‖Hematologic malignancies included MDS (n=16), AML (n=16), ALL (n=4), and multiple myeloma (n=8).
Abbreviations: aPTT, activated partial thromboplastin time; AT, antithrombin; CI, coagulation index; ETP, endogenous thrombin potential; F, factor; MA, maximum amplitude; LY, lysis; PT, prothrombin time; WBC, white blood cell.