Table 2.
Episodes of Alveolar Hemorrhage
| Characteristics | rFVIIa (N = 43 episodes, 23 patients) | Conventional Therapy (N = 14 episodes, 14 patients) | P-value |
|---|---|---|---|
| Timing of AH post-transplant, median days (IQR) | 156 (72-514) | 86 (17-183) | 0.52 |
| Patients with ≥ 2 episodes, n (%) | 10 (43) | 0 (0) | 0.006 |
| Episodes per patient, median (IQR) | 1 (1-2) | 1 (1-1) | 0.014 |
| Time interval between episodes, median days (IQR) | 17 (11-41) | --- | --- |
| GVHD prophylaxis, n (%) | |||
| Cyclosporine | 17 (40) | 5 (36) | 1.00 |
| Tacrolimus | 8 (19) | 3 (21) | 1.00 |
| Sirolimus | 10 (23) | 5 (36) | 0.49 |
| Mycophenolate mofetil | 3 (7) | 3 (21) | 0.15 |
| > 1 agent | 4 (9) | 4 (29) | 0.09 |
| None | 9 (21) | 2 (14)a | 0.71 |
| Laboratory variables at onset of AH, median (IQR) | |||
| Platelet count (103/μL) | 43,000 (23,000-61,000) | 33,500 (25,000-63,000) | 0.60 |
| Prothrombin time (sec)b | 15.1 (14.0-17.0)c | 16.5 (14.9-18.3) | 0.58 |
| Activated partial thromboplastin time (sec)b | 39.1 (32.3-44.9)c | 40.4 (35.1-43.2) | 0.85 |
| ANC (per μL) | 1712 (838-4422)d | 3720 (1024-4852)e | 0.39 |
| ALC (per μL) | 268 (95-944)d, f | 255 (115-642)e | 0.42 |
| Organ failures | |||
| SOFA score, median (IQR)g | 13 (11-18) | 12 (11-14) | 0.23 |
| Need for MV, n (%) | 32 (74) | 9 (64) | 0.64 |
| Highest PaO2/FiO2 at the onset of AH, median (IQR)h | 188 (143-243) | 260 (134-347) | 0.30 |
| Vasopressor use, n (%) | 6 (14) | 0 (0) | 0.32 |
| Need for renal replacement therapy, n (%) | 12 (28) | 2 (14) | 0.48 |
| Outcomes | |||
| Hospital mortality in patients requiring MV for AH, n (%) | 13/21 (62) | 6/9 (67) | 1.00 |
| Overall hospital mortality, n (%) | 15 (65) | 6 (43) | 0.27 |
| 30-day survival rate, n (%) | 14 (61) | 11 (79) | 0.31 |
| 60-day survival rate, n (%) | 11 (48) | 6 (43) | 1.00 |
| 180-day survival rate, n (%) | 8 (35) | 4 (29) | 1.00 |
Abbreviations: IQR indicates interquartile range; GVHD, graft-versus-host disease; μL, microliter; sec, seconds; ANC, absolute neutrophil count; ALC, absolute lymphocyte count; SOFA, Sequential Organ Failure Assessment; MV, mechanical ventilation; PaO2, arterial oxygen tension; FiO2, fraction of inspired oxygen.
Two patients were treated with daclizumab and infliximab alone at the onset of AH
Prothrombin time normal range 11.8-14.7 sec; Activated partial thromboplastin time 23.4-34.5 sec.
Data not available for two episodes.
Four patients had a total leukocyte count of less than 30.
Two patients had a total leukocyte count of less than 150.
One patient with chronic lymphocytic leukemia not included.
The PaO2 was not available for calculating the respiratory variable in 10 episodes (rFVIIa group = 7, conventional = 3). In 3 episodes occurring in the rFVIIa treated group, the variable could be imputed based on oxygen saturation. The 7 remaining episodes were excluded in the main comparison (p = 0.23). In a secondary analysis, missing respiratory values were imputed using the lowest possible value in the rFVIIa group and the highest possible value in the conventional group to recalculate the SOFA score, median (IQR) 12 (9-16) and 11 (9-14), respectively (p = 0.19).
Highest PaO2/FiO2 within the first 24 hours of AH onset. A minority of patients in both groups did not have a blood gas done within the first 24 hours of AH onset (rFVIIa group = 5 patients, 8 episodes; conventional group = 3 patients, 3 episodes).