TABLE 1.
Baseline Features in Indeterminate ALF compared to clinically defined APAP overdose ALF, stratified by Assay Status
| Characteristic | (Group 1) Indeterminate: Assay Negative n=90 | (Group 2) Indeterminate: Assay Positive* n=20 | (Group 3) APAP: Assay Positive* n=188 | (Group 4) APAP: Assay Negative n=11 | Global p-value | Group Comparison¶ |
|---|---|---|---|---|---|---|
| Demographics | ||||||
| Age, years | ||||||
| Median | 39 | 32.5 | 37 | 42 | <0.025 | NS |
| 25th %, 75th %-tile | 27, 51 | 23.5, 38.5 | 30, 45 | 37, 43 | ||
| Female [n (%)] | 43 (47.8) | 16 (80.0) | 140 (74.5) | 6 (54.5) | <0.001 | 1 vs 3 |
| Laboratory Markers | ||||||
| ALT, IU/L | ||||||
| Median | 811 | 5156 | 4025 | 1810 | <0.001 | 1 vs 2 |
| 25th %, 75th %-tile | 335, 1405 | 3463, 8140 | 2422, 6680 | 621, 9386 | 1 vs 3 | |
| AST, IU/L | ||||||
| Median | 691 | 8126 | 4333 | 1808 | <0.001 | 1 vs 2 |
| 25th %, 75th %-tile | 342, 1314 | 5162, 12295 | 2027, 8192 | 277, 10860 | 1 vs 3 | |
| Bilirubin, mg/dL | 1 vs 2 | |||||
| Median | 24.3 | 5.05 | 4.1 | 7.3 | <0.001 | 1 vs 3 |
| 25th %, 75th %-tile | 17.6, 31.7 | 2.5, 6.5 | 3.0, 5.9 | 1.4, 11.1 | 1 vs 4 | |
| APAP-Assay, nmol/mL | <0.001 | 1 vs 2 | ||||
| Median | 0 | 9.2 | 11.1 | 0.25 | 1 vs 3 | |
| 25th %, 75th %-tile | 0, 0.4 | 4.4, 14.3 | 6.7, 18.6 | 0.2, 0.3 | 1 vs 4 | |
| 2 vs 4 | ||||||
| 3 vs 4 | ||||||
| Severity Markers | ||||||
| MELD score | ||||||
| Mean | 35.5 | 34.6 | 31.7 | 33.7 | 0.014 | 1 vs 3 |
| SD | 9.2 | 6.8 | 9.6 | 11.0 | ||
| APAP King’s | ||||||
| Criteria met [n (%)] | 9 (10.0) | 5 (25.0) | 29 (15.4) | 1 (9.1) | NS | |
| Hepatic Coma | ||||||
| Grade (1-4) [n (%)] | ||||||
| 1 | 19 (22.6) | 3 (16.7) | 46 (25.3) | 2 (20.0) | NS | |
| 2 | 26 (31.0) | 3 (16.7) | 43 (23.6) | 1 (10.0) | ||
| 3 | 14 (16.7) | 6 (33.3) | 42 (23.1) | 4 (40.0) | ||
| 4 | 25 (29.8) | 6 (33.3) | 51 (28.0) | 3 (30.0) | ||
| Any NAC Treatment [n (%)] | 16 (17.8) | 8 (40.0) | 177 (94.1) | 9 (81.8) | <0.001 | 1 vs 3 |
| 1 vs 4 | ||||||
| 2 vs 3 | ||||||
| Outcomes | ||||||
| Spontaneous survival [n (%)] | 19 (21.1) | 11 (55.0) | 120 (63.8) | 5 (45.5) | <0.001 | 1 vs 2 |
| 1 vs 3 | ||||||
| Liver transplantation [n (%)] | 39 ( 42.2) | 2 (10.0) | 15 (8.0) | 2 (18.2) | <0.001 | 1 vs 2 |
| 1 vs 3 |
*
Assay positive defined by ≥ 1.0 nmol/ml; NS = not-significant (p>0.05)
¶
Statistically significant two-way Group comparisons shown with adjusted p-values < 0.05; where adjusted p-value defined as actual p-value x number of comparisons made (6)