Inflammatory Markers in Trauma Patient Outcomes: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Inflammatory Markers in Trauma Patient Outcomes (NCT03671746), a randomized phase 1 study. The primary outcome is Length of Hospital Stay.

2. Clinical Question

3. Trial Design

This completed study is recorded as a Phase 1, randomized, triple-masked, parallel-group trial in participants with polytrauma. The registry lists enrollment of 70. One group received standard of care with ketorolac; the other received standard of care with saline. The arm descriptions refer to standard Advanced Trauma Life Support and routine ICU medical care. The registry does not explain who was masked or how masking was maintained.

The primary outcome was length of hospital stay, measured from the electronic health record and assessed over up to 30 days. The reported summary measure is the median, with the inter-quartile range. The posted results give each group’s number of participants, median stay, and inter-quartile limits. The sponsor also reports an analysis using ANOVA and labels its parameter as a median difference in final values.

The registry lists secondary outcomes concerning morphine milligram equivalents in hospital, changes in patient pain scores, changes in interleukin 1a, interleukin 1b, interleukin 6 and interleukin 10, change in prostaglandin E-2, and post-traumatic complications. The record indicates 12 outcome measures, 11 posted secondary outcomes, and 9 analyses. Those counts do not by themselves establish which outcomes were tested, how they were prioritized, or how the analyses were selected.

Further design details, including the allocation procedure, the masking procedures, the treatment schedule, and the analysis populations, are not reported in the registry record. A registry sample-size justification and a detailed statistical analysis plan are also not reported. The study summary says participation would last about 1 year, but that statement does not specify the follow-up window for each outcome.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: No enrolled participants were excluded from the study before assignment to groups.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Length of Hospital Stay, measured over Up to 30 days.

Length of hospital stay measures the time from the start of the recorded hospital stay to discharge, as calculated from the electronic health record. The registry specifies days as the unit and gives a timeframe of up to 30 days. This endpoint captures duration of inpatient care, but the record does not describe how transfers, discharge destination, death, or stays extending beyond the specified timeframe were handled in the calculation.

The results use the median rather than the mean. The median describes the central position of observed stay durations and is less influenced by unusually long stays than the mean. The inter-quartile range describes the spread of the central portion of observations; it gives context about variation within each group, although it does not show every observation or the full distribution.

Hospital stay is used as a measure of resource use and the course of inpatient care. It is not a direct measure of inflammatory response, pain, or opioid consumption, which are also relevant to the study’s aims and appear among the listed secondary outcomes. A stay can reflect multiple aspects of care and patient circumstances. The registry does not report a protocol definition for discharge readiness or explain whether factors beyond clinical recovery could affect the measured duration.

The primary outcome is reported for up to 30 days, while the registry does not describe how observations were treated if hospital stay information was incomplete. That detail matters for interpreting the median and its inter-quartile range, particularly when follow-up or endpoint ascertainment differs between participants.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the median describe?

In general, the median is the middle value when observations are ordered. It is useful when measurements are skewed or include unusually large values, because extreme observations have less influence on it than they do on the mean. For hospital stay, a small number of especially long admissions could pull a mean upward; a median can offer a more robust description of a typical observation. It does not show the shape of the full distribution, however, and two groups can have the same median while differing in other parts of their distributions.

The registry reports the primary endpoint using the median and inter-quartile range. The inter-quartile range describes the spread between the lower and upper quartiles. It gives a compact view of the central part of the observed data, but it is not a confidence interval for the median. The limits reported for each group are descriptive summaries; they do not quantify uncertainty in the group median or in the difference between groups.

What does the sponsor’s analysis report?

The registry labels the sponsor’s method as ANOVA and the parameter as a median difference in final values. In general, ANOVA is a framework for comparing group means under a model. Its usual implementation relies on assumptions about the outcome and residual variation. The record does not state whether the outcome was transformed, whether a particular robust or rank-based procedure was used, or how the reported median-difference parameter was obtained. It also does not report diagnostics or model details. Consequently, the method label alone is not enough to evaluate the analysis fully.

The sponsor’s reported result is an estimate of 1.5 with p = 0.275. In general, a p-value evaluates how surprising the data or a more extreme result would be under a specified null hypothesis and model. It is not an effect-size measure, does not express the probability that the result occurred by chance, and does not indicate whether an effect is clinically important. The registry does not report a confidence interval, which would help describe the uncertainty around the estimated comparison.

Why does uncertainty matter?

In general, a confidence interval combines an estimate with information about its precision under the analysis model. A narrow interval indicates greater precision than a wide interval, but interpretation also depends on the validity of the model and the design. Without an interval for the sponsor’s estimate, readers cannot see which effect sizes are compatible with that analysis at the stated confidence level. The registry record does not report that interval or a confidence level for it.

The sample-size assumptions recorded for planning illustrations describe a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. Such planning calculations are hypothetical illustrations, not evidence about the probability that the completed trial detected an effect. They are not observed power. The registry does not report the trial’s own sample-size justification, and no planning sample-size result should be treated as an observed trial outcome.

How should the summaries be compared?

The descriptive medians and inter-quartile limits show the observed distribution summaries by group. A group-level comparison asks a different question: whether the observed difference is compatible with a null model after accounting for variability and the analysis design. In general, inference about a median may require methods designed for quantiles or distributional comparisons; a test formulated for means does not automatically become a test of medians because the reported parameter is labeled a median difference. The registry does not provide enough methodological detail to determine the precise relationship between the method label and the reported parameter.

Likewise, a comparison of medians cannot be reconstructed from group medians and inter-quartile ranges alone. Individual-level data, or additional model results, would be needed to reproduce many inferential analyses. The registry record itself notes that values are missing or not estimable for a two-arm comparison for the median-time endpoint. No independent recalculated comparison is reported in the registry record.

What other methods issues affect interpretation?

Several secondary outcomes are listed, including pain scores, morphine milligram equivalents, inflammatory markers, and post-traumatic complications. In general, conducting multiple tests increases the chance of obtaining at least one apparently notable result when all null hypotheses are true. A prespecified hierarchy, adjustment method, or clear distinction between confirmatory and exploratory outcomes can help readers interpret a collection of tests. The registry does not report a multiplicity strategy, so the status of the secondary analyses cannot be determined from the record.

Missing-data methods and analysis populations also matter. In general, excluding participants with incomplete outcomes can change the composition of the analyzed groups, while imputation or other methods require assumptions about the missingness process. The record does not report how missing endpoint data were handled, whether all randomized participants were included in the primary analysis, or how protocol deviations were treated. These omissions limit assessment of the precision and potential bias of the reported comparison.

10. Analyses Reported by the Sponsor

The sponsor’s reported comparison is an ANOVA analysis with a stated median difference in final values of 1.5 and p = 0.275. The registry does not report a confidence interval for that estimate or methodological detail explaining how the ANOVA produced the stated median-difference parameter. The descriptive group summaries are medians of 7.0 and 8.0 days, with their respective inter-quartile limits; those values are not a substitute for the sponsor’s inferential analysis.

No independent recalculated comparison is reported in the registry record. The record also notes that values are missing or not estimable for a two-arm comparison for this median-time endpoint. Accordingly, there is no recalculated estimate or test to compare directly with the sponsor’s result. The sponsor’s reported analysis is the available inferential result, but its limited reporting means readers cannot fully assess its assumptions, precision, or reproducibility.

The reported p-value should be interpreted as a model-based measure of compatibility with a null hypothesis, not as a measure of clinical importance or as proof that there is no group difference. Because no confidence interval is reported, the range of effect sizes compatible with the sponsor’s analysis remains unclear. The descriptive statistics and the sponsor’s test answer related but distinct questions.

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 12 outcome measures, 11 posted secondary outcomes, and 9 analyses. The listed secondary outcomes include morphine milligram equivalents in hospital, change in patient pain scores, changes in interleukin 1a, interleukin 1b, interleukin 6 and interleukin 10, change in prostaglandin E-2, and post-traumatic complications. The record does not explain how these outcomes relate to the analysis count or identify which analyses were confirmatory.

Multiplicity arises when several outcomes or comparisons are evaluated. In general, the more hypotheses tested, the greater the opportunity for a result to appear noteworthy by chance, even if no underlying effects exist. Common approaches include adjusting the testing threshold, controlling an error rate, or establishing a prespecified hierarchy. The registry record does not report whether any such strategy was used. Without that information, secondary findings should be interpreted as individual reported analyses rather than as a clearly controlled family of tests.

The registry does not report the handling of missing outcome data. It does not specify whether observations were excluded, imputed, or analyzed using another method, and it does not describe the assumptions used for incomplete follow-up. Missingness can affect both the composition of an analyzed group and the uncertainty of its estimate. The record also does not state whether the primary analysis included all randomized participants or identify any alternative analysis populations.

Further details that would help interpretation, including protocol deviations, endpoint-specific denominators, and the analysis population for each outcome, are not reported in the registry record. The primary outcome summary does give group counts, but those counts alone do not establish how missing data or exclusions were handled. The absence of these details limits assessment of potential bias and prevents a full audit of the analysis choices.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists zero serious adverse events in the standard-care-without-NSAID group and zero in the standard-care-with-NSAID group. It also lists zero deaths in each group. For other adverse events, the posted counts are 6 in the standard-care-without-NSAID group and 3 in the standard-care-with-NSAID group. The registry gives 35 participants at risk in each group for these summaries.

These are event counts as recorded in the registry, not estimates of comparative risk or proof of safety. The record does not report a confidence interval or a statistical comparison for the adverse-event counts. It does not provide the event terms for serious adverse events, and it does not describe how the events were classified, collected, or assessed for relationship to treatment. The follow-up period used for these adverse-event summaries is not reported in the registry record.

Zero recorded serious adverse events does not establish that serious events cannot occur. The other-adverse-event counts likewise do not establish a treatment-related difference. Interpretation depends on the definitions, ascertainment, follow-up, and completeness of reporting, details that are not available in the registry record.

13. What the Result Does, and Does Not, Mean

The posted results describe a randomized comparison of ketorolac plus standard care with saline plus standard care among participants with polytrauma. For the primary outcome, the registry reports median hospital stays and inter-quartile limits for both groups, along with a sponsor-reported analysis. These findings are a record of what was reported for this trial; they do not, by themselves, establish that ketorolac caused a change in hospital stay.

The primary analysis is reported with an estimate of 1.5 and p = 0.275, but no confidence interval is reported. The group summaries and p-value provide some information about the observed data and the sponsor’s test, but they do not fully describe the precision of the estimated comparison. The registry’s limited statistical detail also leaves open questions about the method, analysis population, and missing data.

The result does not answer every question raised by the study rationale. The registry lists outcomes concerning pain, opioid requirements, inflammatory markers, and post-traumatic complications, but the primary hospital-stay result cannot stand in for those outcomes. Their interpretation depends on their own posted results and analysis methods. The registry does not report enough information to infer a complete benefit-risk profile from the primary endpoint and adverse-event counts.

Nor does the record alone establish how broadly the findings apply. It describes a specific trial in a polytrauma population, but further eligibility details and participant characteristics are not reported in the primary-outcome population field. Generalization to other populations or care settings would require information beyond the posted summaries.

The appropriate reading is therefore bounded: the registry reports group-level hospital-stay summaries and a sponsor analysis, with limited detail about uncertainty and methods. These results can inform statistical discussion of the trial, but they should not be treated as definitive proof for or against a treatment effect.

14. Why This Trial Matters Statistically

This trial is statistically interesting because it reports a median-based primary endpoint alongside an ANOVA method label and a parameter described as a median difference. Those labels raise an important reporting question: readers need enough detail to understand how the model, estimand, and displayed group summaries fit together. The registry does not provide that explanation, making it difficult to reproduce or fully evaluate the inferential result.

The endpoint is length of stay, a duration measure that may have a skewed distribution. In general, medians and inter-quartile ranges can be useful summaries for such outcomes, but they do not supply the uncertainty around a treatment contrast. Reporting an effect estimate with a confidence interval and a clear description of the analysis would help distinguish the magnitude of an observed difference from its precision.

The study also lists multiple secondary outcomes spanning analgesia, pain, inflammatory markers, and complications. A transparent account of outcome prioritization and multiplicity handling would help readers judge how much weight to place on each analysis. The registry’s counts of outcome measures, posted secondary outcomes, and analyses do not reveal whether a testing hierarchy or adjustment strategy was prespecified.

Finally, the record illustrates why results need context about missing data, analysis populations, and event ascertainment. These details affect reproducibility and the interpretation of both efficacy outcomes and adverse events. Their absence does not invalidate the posted summaries, but it limits the strength of conclusions that can be drawn from them.

15. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The primary-outcome report gives group medians and inter-quartile limits, but no confidence interval for the sponsor’s estimate. The sponsor’s analysis is labeled ANOVA, while the reported parameter is a median difference in final values. The registry does not explain the model specification or how that estimate was calculated. This makes the inferential result difficult to evaluate independently.

Details about randomization and masking are limited. The study is recorded as randomized and triple masked, but the allocation procedure and the roles of the masked parties are not described. The registry does not report the primary analysis population, handling of protocol deviations, or management of incomplete outcome data. It also does not explain how hospital stays were treated if participants transferred, were discharged to different settings, or had incomplete records.

The endpoint timeframe is up to 30 days, but the registry does not describe the treatment of stays extending beyond that period. It records the measure as calculated from the electronic health record without further detail on the operational definition of the start or end of stay. These omissions constrain reproducibility and interpretation.

Secondary outcomes cover several domains, but the registry does not report an analysis hierarchy or multiplicity strategy. The adverse-event summaries list counts but do not include serious-event terms, a statistical comparison, or details of ascertainment and follow-up. Participant characteristics and further eligibility details are also not reported in the primary-outcome population field, limiting assessment of generalizability.

The record gives planning assumptions for illustrative sample-size calculations, but does not report the trial’s own sample-size justification. Such planning illustrations cannot be interpreted as observed power or as evidence that the study was adequately powered for its outcomes. Overall, the posted record is informative about the reported summaries, while leaving important design, analysis, and reporting details unresolved.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Inflammatory Markers in Trauma Patient Outcomes — NCT03671746.
• Registry record last updated 2025-06-05; status last verified 2025-06.
• Results first posted 2025-06-05.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

19. Record Summary

The registry records a completed, randomized, triple-masked, parallel Phase 1 trial of ketorolac added to standard care versus saline added to standard care in participants with polytrauma. Enrollment is listed as 70. The primary outcome is length of hospital stay in days, measured from the electronic health record over up to 30 days and summarized by median and inter-quartile range.

The reported group summaries are a median of 7.0 days with inter-quartile limits of 3.0 and 10.0 for standard care without NSAID, and a median of 8.0 days with limits of 4.5 and 11.5 for standard care with NSAID. The sponsor reports an ANOVA comparison with a median difference of 1.5 and p = 0.275; no confidence interval is reported. Registry-listed serious adverse events and deaths are zero in both groups. The record does not report several details needed to fully assess analysis methods, missing data, multiplicity, and safety-event ascertainment.