Table 4 Quantitative Laboratory Parameters (Hematology, Chemistry, Coagulation, Urinalysis, Blood Allergy Levels) by Cohort
From: Intraoperative nerve-specific fluorescence visualization in head and neck surgery: a Phase 1 trial
Laboratory Parameter | Dose-defining cohort | Dose-timing cohort | |||
|---|---|---|---|---|---|
Pre-infusion (n = 15) | Day 1 (22 hrs post-infusion) (n = 15) | Pre-infusion (n = 12) | Day 1 (22 hrs post-infusion) (n = 11) | ||
Hematology | Erythrocytes (1012/L) | 4.5 ± 0.6 | 4.2 ± 0.6 | 4.4 ± 0.5 | 4.2 ± 0.4 |
Hemoglobin (g/dL) | 13.4 ± 1.6 | 12.5 ± 1.8 | 13.2 ± 1.6 = 5 | 12.6 ± 1.0 | |
Hematocrit (fraction of 1) | 0.4 ± 0.04 | 0.4 ± 0.05 | 0.4 ± 0.05 | 0.4 ± 0.03 | |
Mean corpuscular volume (fL) | 89.3 ± 6.4 | 89.5 ± 6.8 | 90.3 ± 3.8 | 90.1 ± 4.4 | |
Leukocytes (109/L) | 6.8 ± 3.0 | 12.1 ± 3.0 | 6.4 ± 1.9 | 11.8 ± 2.8 | |
Platelets (109/L) | 263 ± 71 | 265 ± 76 | 245 ± 63 | 242 ± 54 | |
Neutrophils (109/L) | 3.8 ± 2.4 | 9.3 ± 3.2 | 3.8 ± 1.3 | 9.3 ± 2.9 | |
Eosinophils (109/L) | 0.2 ± 0.1 | 0.02 ± 0.1 | 0.2 ± 0.1 | 0.03 ± 0.1 | |
Basophils (109/L) | 0.03 ± 0.04 | 0.01 ± 0.03 | 0.04 ± 0.04 | 0.01 ± 0.3 | |
Lymphocytes (109/L) | 2.3 ± 1.3 | 2.0 ± 1.6 | 1.9 ± 0.7 | 1.7 ± 0.9 | |
Monocytes (109/L) | 0.5 ± 0.2 | 0.7 ± 0.2 | 0.5 ± 0.2 | 0.7 ± 0.2 | |
Chemistry | Alkaline phosphatase (ukat/L) | 1.1 ± 0.4 | 1.0 ± 0.4 | 1.3 ± 0.4 | 1.1 ± 0.3 |
Aspartate aminotransferase (ukat/L) | 0.4 ± 0.1 | 0.5 ± 0.2 | 0.4 ± 0.1 | 0.3 ± 0.1 | |
Alanine aminotransferase (ukat/L) | 0.4 ± 0.2 | 0.4 ± 0.2 | 0.3 ± 0.1 | 0.3 ± 0.1 | |
Bilirubin (umol/L) | 7.5 ± 2.6 | 8.4 ± 4.0 | 7.6 ± 4.8 | 9.1 ± 5.5 | |
Calcium (nmol/L) | 2.3 ± 0.1 | 2.2 ± 0.1 | 2.3 ± 0.1 | 2.2 ± 0.1 | |
Phosphate (nmol/L) | 1.1 ± 0.2 | 1.1 ± 0.3 | 1.1 ± 0.2 | 1.0 ± 0.2a | |
Blood urea nitrogen (nmol/L) | 5.1 ± 1.6 | 4.9 ± 1.6 | 5.3 ± 2.0 | 4.4 ± 1.3 | |
Creatinine (umol/L) | 77.9 ± 15.6 | 72.8 ± 15.2 | 68.4 ± 15.7 | 66.5 ± 12.8 | |
GFR | 84.6 ± 11.2 | 83.6 ± 15.0 | 93.1 ± 19.6 | 94.0 ± 15.6 | |
Protein (g/L) | 71.9 ± 3.9 | 68.1 ± 5.8 | 70.8 ± 4.9 | 65.4 ± 5.0 | |
Albumin (g/L) | 43.2 ± 4.1 | 40.3 ± 3.7 | 43.5 ± 3.2 | 40.1 ± 3.2 | |
Glucose (mmol/L) | 5.7 ± 0.7 | 6.7 ± 1.5 | 6.5 ± 2.8 | 8.7 ± 5.3 | |
Potassium (mmol/L) | 4.2 ± 0.5 | 4.0 ± 0.4 | 4.4 ± 1.1 | 4.0 ± 0.5 | |
Sodium (mmol/L) | 139.1 ± 1.9 | 137.5 ± 3.0 | 138.9 ± 1.6 | 138.2 ± 2.7 | |
Chloride (mmol/L) | 101.6 ± 2.7 | 99.6 ± 3.0 | 103.8 ± 2.5 | 103.2 ± 3.0 | |
Magnesium (mmol/L) | 0.8 ± 0.1 | 0.8 ± 0.1 | 0.9 ± 0.1 | 0.8 ± 0.1 | |
Bicarbonate (mmol/L) | 25.9 ± 2.8 | 25.3 ± 3.0 | 26.0 ± 2.5 | 25.1 ± 1.9 | |
Urate (umol/L) | 315 ± 66 | 255 ± 70 | 292 ± 130 | 235 ± 104 | |
Lactate dehydrogenase (ukat/L) | 3.7 ± 1.2 | 3.3 ± 1.1 | 4.4 ± 2.9 | 3.1 ± 0.7 | |
Coagulation | Prothrombin time (sec) | 12.3 ± 1.0 | 13.2 ± 1.4 | 12.8 ± 1.0 | 13.7 ± 1.3 |
Activated partial thromboplastin time (sec) | 31.1 ± 2.4 | 29.7 ± 2.5 | 33.0 ± 2.5 | 31.4 ± 3.7 | |
INR | 1.1 ± 0.1 | 1.1 ± 0.2 | 1.1 ± 0.1 | 1.1 ± 0.1 | |
Urinalysis | pH | 6.4 ± 0.9 | 6.2 ± 0.9 | 6.0 ± 0.9b | 6.1 ± 1.1a |
Specific gravity | 1.0 ± 0.01 | 1.0 ± 0.01 | 1.0 ± 0.0b | 1.0 ± 0.004a | |
Blood Allergy Levels | Tryptase | 5.4 ± 2.2 | 4.3 ± 1.4c | 5.5 ± 2.0 | 4.3 ± 1.5 |
Complement C3a | 195 ± 100 d | 231 ± 153c | 253 ± 207e | 241 ± 156 | |
Complement C5 | 17.8 ± 3.6 d | 17.3 ± 6.0 d | 15.8 ± 5.1a | 16.8 ± 3.3 | |
