Changes in secondary end points
. | Before therapy . | After cycle 1 . | P* . | After cycle 2 . | P† . | Normal range . | Correlation with hematologic parameters in multivariate regression analysis, P < .05 . |
|---|---|---|---|---|---|---|---|
| Measures of RBC adhesion to endothelium | |||||||
| Adhesion to TSP, RBCs/mm2 | 1570 ± 170 | 690 ± 150 | < .001 | 910 ± 160 | < .001 | < 60 | F-cell % and ANC |
| Adhesion to laminin, RBCs/mm2 | 3470 ± 500 | 1950 ± 300 | .004 | 1570 ± 210 | < .001 | < 250 | F-cell % |
| Measures of thrombin generation and fibrinolysis | |||||||
| D-dimer, ng/mL | 490 ± 90 | 320 ± 50 | .02 | 300 ± 50 | .03 | < 400 | Nil |
| TAT, μg/L | 7.0 ± 1.7 | 8.6 ± 2.3 | .15 | 5.2 ± 0.9 | .11 | 1.0-4.1 | — |
| F1 + 2, nM | 1.75 ± 0.22 | 1.56 ± 0.16 | .23 | 1.41 ± 0.15 | .051 | 0.04-1.1 | — |
| Measure of inflammation | |||||||
| CRP, mg/dL | 1.25 ± 0.27 | 1.19 ± 0.34 | .80 | 0.82 ± 0.26 | .18 | < 0.7 | — |
| Measures of endothelial cell damage | |||||||
| SVCAM, ng/mL | 1170 ± 140 | 930 ± 100 | .01 | 840 ± 100 | .02 | 395-714 | Total Hb |
| VWFpp, U/dL | 196 ± 26 | 156 ± 28 | .015 | 144 ± 13 | .049 | 74-153 | Absolute reticulocyte count |
. | Before therapy . | After cycle 1 . | P* . | After cycle 2 . | P† . | Normal range . | Correlation with hematologic parameters in multivariate regression analysis, P < .05 . |
|---|---|---|---|---|---|---|---|
| Measures of RBC adhesion to endothelium | |||||||
| Adhesion to TSP, RBCs/mm2 | 1570 ± 170 | 690 ± 150 | < .001 | 910 ± 160 | < .001 | < 60 | F-cell % and ANC |
| Adhesion to laminin, RBCs/mm2 | 3470 ± 500 | 1950 ± 300 | .004 | 1570 ± 210 | < .001 | < 250 | F-cell % |
| Measures of thrombin generation and fibrinolysis | |||||||
| D-dimer, ng/mL | 490 ± 90 | 320 ± 50 | .02 | 300 ± 50 | .03 | < 400 | Nil |
| TAT, μg/L | 7.0 ± 1.7 | 8.6 ± 2.3 | .15 | 5.2 ± 0.9 | .11 | 1.0-4.1 | — |
| F1 + 2, nM | 1.75 ± 0.22 | 1.56 ± 0.16 | .23 | 1.41 ± 0.15 | .051 | 0.04-1.1 | — |
| Measure of inflammation | |||||||
| CRP, mg/dL | 1.25 ± 0.27 | 1.19 ± 0.34 | .80 | 0.82 ± 0.26 | .18 | < 0.7 | — |
| Measures of endothelial cell damage | |||||||
| SVCAM, ng/mL | 1170 ± 140 | 930 ± 100 | .01 | 840 ± 100 | .02 | 395-714 | Total Hb |
| VWFpp, U/dL | 196 ± 26 | 156 ± 28 | .015 | 144 ± 13 | .049 | 74-153 | Absolute reticulocyte count |
Statistical analysis of changes in RBC adhesion to TSP and laminin, levels of D-dimers, thrombin-antithrombin (TAT) complexes, prothrombin fragments 1 and 2 (F1 + 2), C-reactive protein (CRP), soluble VCAM (sVCAM), and von Willebrand factor propeptide (VWFpp). Those variables that changed significantly with treatment were analyzed for correlations with the following hematologic parameters: %F-cells, absolute neutrophil counts, total hemoglobin levels, and reticulocyte counts (multivariate regression analysis); significant associations are shown in the last column. Values are mean ± SE. Statistical significance determined by paired 2-tailed t test. Nil indicates no significant relationship; and —, not analyzed.
P, significance of change from before therapy to after cycle 1
P, change from before therapy to after cycle 2