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TEG 6S Clinical Research Dashboard
Comprehensive analysis of neonatal & pediatric applications
Key Neonatal Research Findings
Critical Research Gap Identified
No TEG 6S trials include neonates or premature infants in the dataset. The youngest age group in current trials is 3 months to 18 years (NCT05874843).
Blood Collection Method
All trials use citrated blood (3.2% citric acid) and require reactivation before analysis. No small-volume protocols for neonates identified.
Neonatal Applications
Potential neonatal concerns (tiny blood volumes, different coagulation values) not addressed in any identified trials or publications.
FDA Clearance Status
TEG 6S received FDA 510(k) clearance in 2019 (K183160) with an updated cartridge in 2024. No specific neonatal clearance documented.
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Age Range Summary
| Trial ID | Age Range | Neonatal Inclusion | Relevant Population |
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TEG 6S Clinical Trials
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Neonatal Research Gap Analysis
Current Limitations
- No trials include neonates (<28 days) or premature infants
- Youngest cohort: 3 months to 18 years (NCT05874843)
- Blood volume constraints of neonates not addressed in any protocols
- No specific neonatal reference ranges available for TEG 6S parameters
- Citrated blood draw procedures not validated for very small volume collections
Clinical Implications
- Premature and newborn infants have distinct coagulation profiles compared to older children and adults
- Standard blood collection volumes may be excessive for neonates with limited blood volume
- Interpretation of TEG 6S results in neonates would require specific reference ranges
- Risk/benefit ratio of TEG 6S testing in neonates has not been formally assessed
Research Opportunities
- Validation study of TEG 6S in neonatal populations with age-appropriate reference ranges
- Development of micro-sampling techniques compatible with TEG 6S cartridges
- Comparison of citrated vs. non-citrated samples in neonatal blood
- Assessment of minimal blood volume requirements for valid results
Overall Drug Success Rates
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Response Rate Distribution
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| Drug | Trials | Total Patients | Avg. Effect Size | Response Rate | Remission Rate |
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Comparative Phase Performance
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Statistical Summary
| Phase | Trials | Mean Effect | Standard Deviation | 95% CI | p-value |
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