Table 4.
Details for Analysis of Primary Outcome Adjusting for Pre-specified Covariates and Baseline Variables that were not Balanceda.
| Multiple Imputation pooled estimates | Odds ratios | 95% Confidence Interval |
p-Value |
|---|---|---|---|
| Factor 1: Epo 2 Regimen Analysis | |||
| Epo 2 Regimen - Logistic Regression Model Adjusted for Pre-specified Covariates | |||
| Intercept | 9.48 | 1.58-57.03 | 0.01 |
| Epo 2 (compared to Placebo) | 0.63 | 0.27-1.48 | 0.29 |
| Injury Severity Score | 0.99 | 0.94-1.04 | 0.63 |
| IMPACT probability of unfavorable GOS (per 10% unit increment) |
0.53 | 0.41-0.67 | <0.001 |
|
Epo 2 Regimen - Logistic Regression Model Adjusted for Pre-specified Covariates and for Baseline
Variables that were not Balanced | |||
| Intercept | 9.73 | 1.62-58.56 | 0.01 |
| Epo 2 (compared to Placebo) | 0.69 | 0.29-1.65 | 0.40 |
| Injury Severity Score | 0.99 | 0.94-1.04 | 0.60 |
| IMPACT probability of unfavorable GOS (per 10% unit increment) |
0.50 | 0.38-0.64 | <0·001 |
| Prehospital hypoxia present | 2.55 | 0.78-8.28 | 0.12 |
| Factor 1: Epo 1 Regimen Analysis | |||
| Epo 1 Regimen - Logistic Regression Model Adjusted for Pre-specified Covariates | |||
| Intercept | 9.09 | 1.44-57.52 | 0.02 |
| Epo 1 (compared to Placebo) | 1.56 | 0.60-4.08 | 0.36 |
| Injury Severity Score | 0.99 | 0.93-1.04 | 0.58 |
| IMPACT probability of unfavorable GOS (per 10% unit increment) |
0.55 | 0.44-0.69 | <0.001 |
|
Epo 1 Regimen - Logistic Regression Model Adjusted for Pre-specified Covariates and for Baseline
Variables that were not Balanced | |||
| Intercept | 8.84 | 1.39-56.41 | 0·01 |
| Epo 1 (compared to Placebo) | 1.78 | 0.66-4.83 | 0·24 |
| Injury Severity Score | 0.99 | 0.93-1.04 | 0·51 |
| IMPACT probability of unfavorable GOS (per 10% unit increment) |
0.52 | 0.41-0.66 | <0·001 |
| Prehospital hypoxia present | 2.28 | 0.64-8.06 | 0·16 |
| Factor 2: Transfusion Threshold Analysis | |||
| Transfusion Threshold: GOS logistic regression model adjusted for pre-specified covariates | |||
| Intercept | 11.10 | 2.10-58.60 | 0.005 |
| 10 g/dl threshold (compared to 7 g/dl threshold) | 0.75 | 0.36-1.55 | 0.43 |
| Injury Severity Score | 0.98 | 0.94-1.03 | 0.43 |
| IMPACT probability of poor outcome (per 10% unit increment) |
0.54 | 0.44-0.66 | <0.001 |
|
Transfusion Threshold: GOS logistic regression adjusted model adjusted for pre-specified covariates
and baseline variables that were not balanced | |||
| Intercept | 11.47 | 2.06-63.84 | 0.006 |
| 10 g/dl threshold (compared to 7 g/dl threshold) | 0.61 | 0.28-1.30 | 0.20 |
| Injury Severity Score | 0.98 | 0.93-1.02 | 0.33 |
| IMPACT probability of poor outcome (per 10% unit increment) |
0.54 | 0.44-0.67 | <0.001 |
| Presence of epidural hematoma | 4.74 | 1.63-13.73 | 0.004 |
a
Pre-specified covariates were injury severity score and IMPACT probability of poor outcome. Baseline covariates that were not balanced were prehospital hypoxia for the Epo comparison and presence of epidural hematoma for the trigger comparison.