Appendix Table 1.
Baseline and Treatment Characteristics of the Subjects in Safety Sample*
| Albumin (N=416) | Saline Control (N=414) | |
|---|---|---|
| Demographics | ||
| Age (mean, SD) | 63.5 (12.9) | 64.9 (12.9) |
| Sex, male (%, n) | 52.9% (220) | 56.0% (232) |
| Caucasian (%, n) | 74.5% (310) | 72.8% (302) |
| Black (%, n) | 16.1% (67) | 20.3% (83) |
| Asian (%, n) | 6.0% (25) | 4.8% (20) |
| Medical History | ||
| Hypertension | 71.9% (299) | 70.5% (292) |
| Atrial fibrillation | 18.8% (78) | 18.6% (77) |
| Past congestive heart failure | 4.1% (17) | 6.3% (26) |
| Past myocardial infarction | 10.6% (44) | 12.1% (50) |
| Past stroke | 20.9% (87) | 18.6% (77) |
| Past transient ischemic attack | 12.3% (51) | 11.8% (49) |
| Diabetes mellitus | 18.5% (77) | 22.5% (93) |
| Hyperlipidemia | 46.6% (194) | 51.0% (211) |
| Peripheral vascular disease | 5.0% (21) | 6.0% (25) |
| Clinical Factors | ||
| NIHSS score (median, iqr) | 10 (9) | 11 (9) |
| ASPECTS > 7 (%, n/N) | 77.4% (319/412) | 78.0% (323/410) |
| OCSP clinical stroke type | ||
| TACS | 24.3% (101) | 23.4% (97) |
| PACS | 55.3% (230) | 56.0% (232) |
| LACS | 12.0% (50) | 11.1% (46) |
| POCS | 8.4% (35) | 9.4% (39) |
| Thrombolysis | 83.2% (246) | 86.0% (356) |
| Intravenous tPA only | 66.6% (277) | 69.8% (289) |
| Intravenous tPA plus any endovascular procedure | 16.6% (69) | 16.2% (67) |
| Any endovascular procedure only | 5.8% (24) | 2.9% (12) |
| No thrombolysis | 11.1% (46) | 11.1% (46) |
| Systolic BP, mm Hg (mean, SD) | 155 (28) | 157 (30) |
| Glucose, mmol/L (mean, SD) | 7.1 (2.5) | 7.7 (3.7) |
| Hemoglobin, g/L (mean, SD) | 139 (17) | 140 (18) |
| Creatinine, μmol/L (mean, SD) | 86.3 (23.1) | 90.3 (26.9) |
| ECG at baseline shows normal sinus rhythm (%, n) | 72.3% (297) | 72.9% (296) |
| Process Measures | ||
| Stroke onset to initiation of study drug infusion (min) [median, iqr] | 200 (82) | 198 (75) |
| Stroke onset to initiation of intravenous tPA (min) [median, iqr] | 126 (71) | 131 (68) |
| Initiation of IV tPA to initiation of study drug infusion (min) [median, iqr] | 60 (31) | 60 (32) |
| Post-treatment – Fluids and Cardiac Status | ||
| Total IV fluids administered within 48 hours of randomization (ml) (mean (SD); [min, max]) | 3284 (1669); [416,15006] | 3249 (1629); [432, 11235] |
| ECG at 24 hours shows normal sinus rhythm (%, n) | 70.3% (275) | 78.3% (313) |
tPA = tissue plasminogen activator; OCSP = Oxfordshire Community Stroke Project stroke classification (TACS = total anterior circulation syndrome; PACS = partial anterior circulation syndrome; LACS = lacunar syndrome; POCS = posterior circulation syndrome); BP = blood pressure; IV = intravenous; ECG = electrocardiogram
Hill MD, Martin RH, Palesch YY, Moy CS, Tamariz D, Ryckborst KJ, Jones EB, Weisman D, Pettigrew C, Ginsberg MD: Safety analysis of the ALIAS Part 2 Multicenter Trial (manuscript in preparation)
Race and ethnic group were self-reported.
The National Institutes of Health Stroke Scale (NIHSS) is a 42-point scale that quantifies neurological deficits in 11 categories, with 0 indicating normal function without deficits, and higher scores indicating greater severities of deficit.
The Alberta Stroke Program Early Computed Tomography Score (ASPECTS) uses computed tomography to assess 10 regions of the brain; a score of 1 indicates a normal region and 0 indicates a region showing signs of ischemia. Total scores range from 10 (no evidence of early ischemia) to 0 (all 10 regions of the affected hemisphere show early ischemic changes).