Table 1.
Schedule of data and sample collection.
| Data and samples collected |
Preoperative | Perioperative | Postoperative | ||||||||||||
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|
Pre-surgery | Start of CPBa | 10m post CPB | XCb removal | XC+ 30mc | XC+ 2hd | XC+ 4h | XC+ 6h | XC+ 24h | XC+ 48h | XC+ 72h | Discharge | 3 moe | 12 mo | |
| Eligibility | ✓f |
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| Consent | ✓ |
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| NEPSY-IIg | ✓ |
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✓ | ✓ |
| Baseline data | ✓ |
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| Randomization |
|
✓ |
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| Routine blood gases |
|
✓ |
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✓ | ✓ | ✓ |
|
✓ | ✓ |
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| Routine blood samples |
|
✓ |
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✓h |
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✓ | ✓ | ✓ |
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| GFAP |
|
✓ |
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✓ | ✓ | ✓ |
|
✓ | ✓ | ✓ |
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| NIRS |
|
✓i |
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| Urine samples |
|
✓ |
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✓j |
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✓ |
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✓ | ✓ |
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| Cardiac tissue biopsies |
|
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✓ | ✓ |
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| Operative details |
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✓ | ✓ | ✓ | ✓k |
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| Clinical outcomes |
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✓ |
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| Safety data |
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✓ | ✓ | ✓ | ✓ | ✓l | ✓ |
aCPB: cardiopulmonary bypass
bXC: cross clamp
cm: minutes
dh: hours
emo: months
f✓ = data/sample collected
gOnly performed on participants eligible for NEPSY-II psychometric assessment.
hRoutine blood samples taken on admission to PICU.
iAs many NIRS results will be recorded as are taken in theater.
jUrine samples taken at cross-clamp removal/end of CPB.
kOperative details are recorded on cross-clamp removal and chest closure.
lHospital admission questionnaire only administered if 3-month NEPSY administered.