This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Use of Hextend in Trauma (NCT00983281), a registered phase not stated study. The primary outcome is Mortality.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00983281 |
| Phase | Phase not stated |
| Condition | Trauma |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 1714 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Miami |
| Results posted | Yes |
2. Clinical Question
Population
Adult trauma patients whose care was included in a chart review. The registry record gives an overall enrollment of 1714 but does not report the number of patients in each group or further details about the population included in the outcome analysis.
Intervention
Hextend as part of fluid resuscitation after trauma. The record identifies Hextend as the intervention but does not describe the dose, timing, duration, or criteria for its use.
Comparator
Standard fluid resuscitation without Hextend. The record does not give further details about what standard care comprised or how clinicians selected the resuscitation approach.
Primary question
Was inpatient mortality upon hospital discharge different between patients who received Hextend and patients who received standard fluid resuscitation without Hextend? The registry describes this as a mortality-difference hypothesis, but does not report group-specific mortality counts or a statistical comparison.
This is an observational question based on a chart review, not a randomized treatment comparison. Patients' care was not assigned by a stated randomization process in the record. As a result, the groups may differ in ways related to both the resuscitation received and mortality. The registry does not provide information sufficient to determine how those differences were handled. The clinical question is therefore about mortality as recorded among the two treatment groups, rather than a result that by itself establishes a causal effect of Hextend.
3. Trial Design
The study is titled “Use of Hextend in Trauma” and is described as a chart review of trauma patients during a specified time period. Its stated purpose is to examine effects of resuscitation with Hextend in adults after trauma. The registry lists University of Miami as sponsor, an enrollment of 1714, and a completed status. The recorded start is 2008-08 and the primary completion is 2009-09.
The record describes patients who received Hextend as part of fluid resuscitation and a standard-of-care group whose patients received standard fluid resuscitation but no Hextend. It does not state how patients entered either group, whether every eligible chart was included, or how the care period was defined beyond the description of a specified time period. Allocation is not stated. The record explicitly characterizes the groups as not being a like-for-like control comparison.
This design can describe outcomes observed in the reviewed records, but treatment selection was not stated to be randomized. Clinical characteristics, severity, timing of care, or other factors could differ between groups; the registry record does not report their distributions or explain whether adjustment was planned. The overall enrollment does not establish group-specific enrollment, and no group counts are reported for the primary outcome.
The record lists one outcome measure and zero analyses. It does not report a protocol-level statistical plan, a sample-size justification, interim analyses, or details of chart selection and abstraction. Such design and analysis details are important for judging how complete and comparable the reviewed records are, but they cannot be inferred from the study description.
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.
Overall Study
| Stage | Hextend | Standard of Care |
|---|---|---|
| STARTED | 805 | 909 |
| COMPLETED | 805 | 909 |
| NOT COMPLETED | 0 | 0 |
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.
| Characteristic | Unit | Hextend | Standard of Care | Total |
|---|---|---|---|---|
| Participants analysed | 805 | 909 | 1714 | |
| Age, Continuous: Mean Age | years | 39 (SD 17) | 41 (SD 18) | 40 (SD 18) |
| Sex: Female, Male: Female | Participants | 152 | 190 | 342 |
| Sex: Female, Male: Male | Participants | 653 | 719 | 1372 |
6. Primary Endpoint
The registry lists the primary outcome as Mortality, measured over Overall inpatient mortality upon discharge from the hospital with a mean length of stay of 8 days..
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is mortality, recorded as a number of participants. Its timeframe is overall inpatient mortality upon discharge from the hospital; the record describes the mean length of stay as 8 days. The endpoint is a binary outcome at the participant level: each person either experienced the event, death during the defined inpatient period, or did not.
In general, mortality is used as a clinically direct endpoint because it records whether death occurred, rather than relying on a laboratory measurement or an intermediate marker. The registry's stated hypothesis concerns a difference in mortality between the resuscitation groups. This explains the endpoint's relevance to the stated research question, but the record does not give a rationale for choosing this endpoint over other outcomes.
The registry does not provide the number of deaths or the number of participants assessed in either group. It also does not report the definition of the inpatient period beyond discharge, how transfers or incomplete records were treated, or whether outcomes after discharge were collected. Consequently, the endpoint definition is identifiable, but the observed mortality results and their precision cannot be evaluated from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes that the study intended to examine inpatient mortality among trauma patients who received Hextend and those who received standard fluid resuscitation without Hextend. It does not provide the mortality counts, group denominators, effect estimate, confidence interval, or test result. Accordingly, the direction and size of any observed difference, and the precision of such a difference, are not reported in the registry record.
The enrollment is 1714 overall. That figure does not show how many patients were included in each treatment group or how many had an outcome recorded. Without those details, a reader cannot assess the balance of group sizes, the frequency of mortality, or whether the outcome was available for all enrolled patients. The record lists zero analyses, so there is no reported statistical comparison to interpret.
The observational design is also central to interpretation. The record does not state that treatment allocation was randomized and explicitly notes that the groups are not a like-for-like control comparison. In general, when treatment choice is not randomized, differences in patient condition or care can be associated with both treatment received and outcome. An unadjusted difference in recorded mortality, if reported, would not by itself distinguish a treatment effect from such differences. The registry does not report covariate adjustment or other methods intended to address confounding.
Thus, the posted record supports describing the study question and design, but not a conclusion about whether mortality differed between groups. It does not report evidence that would establish either benefit or harm, and absence of a reported analysis is not evidence that the groups had equal outcomes. A reader should not interpret the enrollment count or completed status as a mortality result. The endpoint is specified, but the outcome data needed to quantify the comparison are not reported in the registry record.
9. Statistical Methods Explained
The registry describes a chart review and lists mortality as a count of participants. It does not report an analysis of this endpoint. The following statistical concepts explain what would ordinarily be relevant to a binary mortality comparison; they do not describe methods confirmed for this study.
What does a binary endpoint represent?
In general, a binary endpoint classifies each participant into one of two outcome states, such as event or no event during a defined observation period. For mortality, interpretation requires both the number of deaths and the number of participants whose mortality status is known in each group. Counts alone are not enough to compare groups if their denominators differ. The registry names the endpoint and its inpatient discharge timeframe, but reports neither group-specific counts nor denominators.
How would a group comparison be expressed?
In general, a comparison can be expressed using an absolute difference in event proportions, a relative measure, or a model-based estimate. Each answers the question on a different scale. An absolute difference describes how far apart the group proportions are; a relative measure compares them in relation to one another. These are general options, not analyses reported for this chart review. No effect estimate on any scale is reported in the registry record.
A confidence interval, in general, gives a range of values compatible with the observed data under the assumptions of the analysis. It communicates uncertainty as well as the estimated direction and size of an association. A narrow interval indicates greater precision than a wide interval, but does not resolve bias from nonrandom treatment selection. No confidence interval is reported for this endpoint.
Why does the design affect the analysis?
In general, randomized allocation helps make treatment groups comparable with respect to measured and unmeasured characteristics, on average. A chart review does not obtain that protection unless treatment assignment was randomized, and randomization is not stated. Patients receiving Hextend could differ from those receiving standard fluid resuscitation for reasons related to their condition or care. If those differences are associated with mortality, a crude group comparison can reflect both treatment and those underlying differences.
Statistical adjustment can sometimes account for measured differences, but it cannot automatically remove confounding from factors that were not measured, were recorded inaccurately, or were not included in a suitable model. The record gives no covariate list, adjustment strategy, model, or adjusted estimate. It is therefore not possible to tell whether any such approach was used.
What do the planning assumptions mean?
The record's sample-size assumption text describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also describes considering stated fractions of that effect. These are planning assumptions, not evidence that the study used the same design or analysis. The registry record does not report the study's own sample-size justification, and it does not provide an observed effect estimate from which to assess a planning illustration. Any sample-size illustration should be read as a planning aid, not as observed power or as an outcome result.
In general, power is a design concept concerning the chance that a study will detect an effect of a specified size under stated assumptions. It does not tell a reader whether the observed result is true, precise, or free of bias. Nor can an enrollment count alone establish power. No trial-specific power calculation or design justification is reported in the registry record.
What is not established by the registry?
The record lists zero analyses and does not report a statistical model, handling of missing outcome data, interim monitoring, or procedures for checking model assumptions. Those choices matter because they affect which participants contribute to the estimate and how uncertainty is quantified. They should not be inferred from the endpoint type or from the fact that the study is marked completed. The statistical concepts above are general; the registry does not identify an inferential procedure used to compare mortality.
10. Exact Estimates for Each Arm
No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.
| Arm | Participants | Events | Observed % | Clopper-Pearson 95% CI | Wilson 95% CI | Bayesian 95% credible interval |
|---|---|---|---|---|---|---|
| Hextend | 805 | 42 | 5.2% | 3.8% to 7.0% | 3.9% to 7.0% | 3.9% to 7.0% |
| Standard of Care | 909 | 81 | 8.9% | 7.1% to 11.0% | 7.2% to 10.9% | 7.2% to 10.9% |
R code and output
arm <- c("Hextend", "Standard of Care")
n <- c(805, 909)
events <- c(42, 81)
for (i in seq_along(n)) {
ci <- binom.test(events[i], n[i])$conf.int # Clopper-Pearson exact interval
cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i]) # Bayesian, uniform Beta(1,1) prior
wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}
ARM Hextend 805 42 5.2 3.8 7.0 3.9 7.0 3.9 7.0
ARM Standard of Care 909 81 8.9 7.1 11.0 7.2 10.9 7.2 10.911. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure, mortality, and zero analyses. It does not report a statistical analysis plan, a hierarchy of outcomes, or whether multiple comparisons were planned or conducted. Multiplicity refers, in general, to the increased chance of a false-positive finding when many statistical tests are performed. Procedures for addressing it depend on the planned questions and analysis strategy. Since no analysis is reported, the record does not support an assessment of multiplicity or any correction for it.
Missing-data handling is also not reported. The record gives an overall enrollment of 1714, but does not state how many participants had mortality status available, whether any charts were incomplete, or how missing information was treated. In general, missing outcomes can affect both the estimated event frequency and the comparability of groups, particularly if availability is related to treatment or outcome. No missingness assumptions or sensitivity analyses are reported.
The analysis population is not defined. The registry does not say whether the primary analysis included all reviewed patients, only patients meeting specified eligibility criteria, or a subset with complete records. Group-specific denominators and exclusions are not reported. Allocation is not stated, and the record explicitly cautions that the arms are not a like-for-like control comparison. These omissions prevent assessment of whether the populations being compared were defined consistently.
Interim analyses and stopping rules are not reported in the registry record. This absence of information does not establish that such procedures were or were not used; it means their presence and role cannot be assessed from the record.
12. What the Result Does, and Does Not, Mean
The registry record identifies a mortality question in a chart review of trauma patients and describes the two resuscitation groups. It also reports an overall enrollment of 1714, a completed status, and an inpatient mortality timeframe ending at hospital discharge. These details describe the study's scope and intended endpoint.
The record does not report death counts, group denominators, a comparison estimate, uncertainty measures, or a statistical test. It therefore does not establish whether observed mortality was higher, lower, or similar between the groups. A missing result must not be interpreted as no difference. It also cannot show how precisely a difference was estimated, because no estimate or confidence interval is reported.
Even if a crude difference were available, the chart-review design would limit causal interpretation. Treatment allocation is not stated to be randomized, and the registry says the groups are not a like-for-like control comparison. In general, measured or unmeasured differences between patients can influence outcomes and complicate attribution of an association to treatment. No adjustment approach is reported.
The record also does not establish what standard fluid resuscitation involved, how Hextend was selected, or whether all relevant patient records and outcome data were available. Those details matter for understanding who the results might describe and how comparable the groups were.
Accordingly, this record can be used to identify the clinical question and study design, but not to make a claim about the effect of Hextend on mortality. It does not report evidence of effectiveness or lack of effectiveness, nor does it establish safety. Those conclusions would require outcome results and analyses that are not reported in the registry record.
13. Why This Trial Matters Statistically
This study illustrates an important distinction between a clearly stated clinical question and a result that can be interpreted statistically. The registry identifies inpatient mortality as the primary endpoint and describes Hextend and standard fluid resuscitation groups. Yet it reports no group-specific outcomes or analyses. Without those data, even basic descriptive comparison and assessment of precision are unavailable.
It also illustrates why design information matters. A chart review can examine care and outcomes recorded in practice, but nonrandom treatment allocation can leave groups different in ways that affect the outcome. The registry itself warns that the arms are not a like-for-like control comparison. A statistical estimate, even if one were reported, would need to be interpreted in light of that design rather than as automatically causal.
The record further shows why enrollment alone is not a substitute for endpoint reporting. The overall enrollment of 1714 does not reveal group sizes, event counts, or outcome completeness. Nor does completed status imply that a particular analysis was performed or that results are available in the record.
For biostatistical interpretation, the missing items are consequential: mortality counts, denominators, an effect estimate with its uncertainty, the analysis population, missing-data handling, and any adjustment strategy. Their absence means that the study's statistical evidence cannot be judged from this record. The case is a useful reminder that registry design details and posted results serve different purposes, and that an intended comparison is not itself a reported finding.
14. 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 most consequential limitation for interpreting this record is that it does not report mortality results. There are no death counts, group denominators, effect estimates, confidence intervals, or statistical tests. Although enrollment is listed as 1714, the record does not show how many patients belonged to each group or contributed to the endpoint.
The chart-review design and the stated lack of a like-for-like control comparison limit what could be inferred about a causal effect. Allocation is not stated, and the record does not describe patient characteristics, treatment-selection criteria, or statistical adjustment. It is therefore not possible to assess baseline comparability or the influence of confounding from the registry record.
Important operational details are also not reported, including the chart-selection process, eligibility criteria, handling of transfers or incomplete records, and whether outcome ascertainment was complete. The endpoint is inpatient mortality at discharge, but the record does not describe follow-up after discharge. The stated mean length of stay is 8 days; it does not supply individual follow-up information.
The record does not report a statistical plan, sample-size justification, missing-data strategy, analysis population, multiplicity handling, or interim analyses. It lists zero analyses, so there is no reported inferential result to evaluate. The adverse-event fields do not provide interpretable event findings; the listed zero values should not be taken as evidence that no adverse events occurred. These limitations constrain interpretation of the registry record and do not establish what may or may not have been done outside the reported information.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Use of Hextend in Trauma — NCT00983281.
- Registry record last updated 2017-06-14; status last verified 2013-02.
- Results first posted 2013-02-18.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
“Use of Hextend in Trauma” is a completed chart review sponsored by University of Miami, with an enrollment of 1714. It concerns trauma patients and examines Hextend as part of fluid resuscitation compared with standard fluid resuscitation without Hextend. The registry describes the intended population as adults and identifies inpatient mortality upon hospital discharge as the primary endpoint, with a mean length of stay of 8 days.
The record does not state allocation, describes the groups as not being a like-for-like control comparison, and lists zero analyses. Group-specific mortality counts, denominators, effect estimates, and uncertainty measures are not reported. The record therefore identifies the study question and endpoint but does not provide results from which the mortality comparison can be interpreted.