Key data collection points
| Preoperation | Operation day | Day 1 | Day 2 | Day 3 | Day 4 | Discharge | 6 weeks | 3 months | |
|---|---|---|---|---|---|---|---|---|---|
| Eligibility | ✓ | ||||||||
| Written consent | ✓ | ||||||||
| Randomisation | ✓ | ||||||||
| EQ5D Questionnaire | ✓ | ✓ | ✓ | ✓* | |||||
| Bloods: serum biochemistry (creatinine and troponin T/I) | ✓† | ✓† (CICU and 6–12 h) | ✓† (24 h) | ✓† (48 h) | ✓† (72 h) | ✓‡ (96 h) | ✓‡ | ||
| Bloods: serum inflammatory biomarkers | ✓† | ✓† (CICU and 6–12 h) | ✓† (24 h) | ✓† (48 h) | ✓† (72 h) | ✓‡ (96 h) | ✓‡ | ||
| Bloods: full blood counts | ✓ | ✓ (CICU and 6–12 h) | ✓ (24 h) | ✓ (48 h) | ✓ (72 h) | ✓‡ (96 h) | ✓‡ | ||
| Bloods: plasma sample for MP analysis and monocyte activation | ✓ | ✓ (CICU) | ✓ (24 h) | ✓ (48 h) | |||||
| Urine sample and volume: NGAL, urea and elecrolytes | ✓ | ✓ (6 and 12 h) | ✓ (24 h) | ✓†§ (48 h) | |||||
| Operative details | ✓† | ||||||||
| Clinical outcomes | ✓ | ✓ | ✓¶ | ||||||
| Serious adverse event monitoring | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓¶ | ||
| Resource use data | ✓ | ✓¶ | ✓* | ||||||
| Bloods: platelet response** | ✓** | ✓** (CICU and 6–12 h) | ✓** (24 h) | ✓** (48 h) |
*Indicates data collection via postal questionnaire.
†Indicates samples taken as part of normal care.
‡Discharge time point if hospital stay exceeds 5 days.
§Indicates sample for determination of routine urea and electrolytes only.
¶The 4–6-week time point in accordance with normal postoperative care.
**Indicates Glenfield patients alone.
CICU, cardiac Intensive care unit; NGAL, neutrophil gelatinase-associated lipocalin.