Gelatines in Pediatric PatientS: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Gelatines in Pediatric PatientS (NCT02495285), a registered phase not stated study. The primary outcome is Dosing of the Products During Surgery.

2. Clinical Question

3. Trial Design

This registry entry describes a non-interventional observational study, not a randomized trial. Its stated aim was to gather further information about gelatine solutions in a large pediatric population during routine clinical practice. The registry lists Gelofusine 4% and Gelaspan 4% as the products studied and gives children age ≤ 12 years as the population for both groups. Enrollment is recorded as 601.

The study status is COMPLETED. The recorded start is 2015-05, and primary completion is 2020-05. The sponsor is B. Braun Melsungen AG. These registry entries identify the study and its administrative timeline; they do not describe how treatment choices were made at individual sites or for individual children. Allocation is not stated, and the record explicitly notes that the groups are not a like-for-like control comparison.

The primary outcome is dosing of the products during surgery. The listed measure is a mean with standard deviation, in ml/kg, over the timeframe before (0 - 2 h) and up to 2 h after infusion of gelatin solutions. Other listed outcomes include laboratory measures and adverse events or reactions. Although 12 outcome measures are recorded, the registry lists 0 analyses. The primary outcome values, secondary outcome results, and any analysis methods used for reported results are not reported in the registry record.

Because the study is observational, its group descriptions establish which products were recorded, not an experimental assignment. The record does not give enough information to assess why one product was used rather than the other, or whether the patients receiving each product were comparable in clinical circumstances.

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: Enrolment target of 1500 patients was not met due to slow recruitment although duration of study had been extended to 60 months

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 Dosing of the Products During Surgery, measured over Before (0 - 2 h) and up to 2 h after infusion of gelatin solutions.

The primary outcome is titled “Dosing of the Products During Surgery.” It measures the amount of gelatine solution administered relative to body weight, expressed in ml/kg. The registry specifies a mean and standard deviation and a timeframe before (0 - 2 h) and up to 2 h after infusion of gelatin solutions. The actual mean and standard deviation for either group are not reported in the registry record.

As a general statistical concept, expressing an amount per kilogram puts the dose on a body-weight scale, which is relevant when studying children with different body sizes. A mean describes the average recorded value in a group; a standard deviation describes how much individual values vary around that average. These summaries can characterize dosing patterns, but they do not by themselves establish why doses differed or whether one product caused a difference.

The timeframe identifies when dosing is considered in relation to infusion. It does not, by itself, establish the exact measurement schedule, whether every child contributed a value at each time, or how values were handled when observations were missing. Those details are not reported in the registry record. The outcome is a measure of product dosing, rather than a direct measure of a clinical benefit or harm.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What does the primary measure summarize?

The primary measure is a continuous outcome: dosing in ml/kg, summarized by a mean and standard deviation. As a general explanation, a continuous measure can take values along a scale rather than being only a category or event count. A mean gives a group-level center, while a standard deviation describes the spread of individual measurements around that center. The mean and standard deviation answer different questions: the first describes the average recorded dose, and the second describes variation in recorded doses.

Neither summary is reported for the primary outcome in the registry record. Without the values, it is not possible to describe the observed dosing pattern or judge whether the average is estimated precisely. The timeframe is specified as before (0 - 2 h) and up to 2 h after infusion of gelatin solutions. The registry does not give further detail on measurement occasions, repeated observations, or how a participant's observations were combined.

Why does the observational design matter?

In general, random allocation can help make groups comparable in expectation with respect to factors that influence outcomes. This study is identified as non-interventional and not a randomized comparison; allocation is not stated. Thus, the product groups should be read as groups observed in routine care, rather than as groups formed by a documented random assignment. If patient condition, procedure, or other aspects of care influenced which product was used, those factors could also relate to dosing and outcomes. The registry does not report details that permit evaluation or adjustment of such potential confounding.

This is why a descriptive difference, if reported, would not alone identify a causal effect of the product. A causal interpretation would require a design and analysis that address the possibility that groups differed for reasons other than the product received. The posted registry information does not report a comparative estimate or an adjusted analysis for the primary outcome.

How should uncertainty be understood?

As a general concept, sampling uncertainty arises because measurements from a study population are used to estimate a broader pattern. A confidence interval is one way to show the range of values compatible with an estimate under a statistical model and its assumptions. Its width reflects precision, while its location reflects the estimate. Neither a confidence interval nor a p-value for the primary outcome is reported in the registry record. It is therefore not possible to quantify the precision of the primary result from the registry entry.

Standard deviation should not be mistaken for the uncertainty of the estimated mean. The standard deviation describes variation among observations; the standard error describes uncertainty in an estimated mean. In general, interpreting either requires knowing the analysis population and the amount of available data. Those details and the primary outcome summaries are not reported in the registry record.

What do planning calculations mean?

The sample-size assumptions describe planning illustrations computed from an observed effect, using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. They are not stated to be the study's own design assumptions. For non-time-to-event outcomes, the illustrations are expressed as participants per arm; time-to-event calculations would instead use total events. The record does not report the numerical planning results or the underlying effect estimate.

In general, a planning calculation asks how much information might be needed to detect an effect under selected assumptions. Such a calculation depends on the target effect and statistical assumptions; it does not describe the certainty of findings after the study. A sample-size illustration based on an observed effect is not observed power and cannot be used as a substitute for a confidence interval, a result estimate, or a documented prospective design rationale. The registry record does not report a sample-size justification for the study itself.

Why can variation exceed a simple model's expectations?

As a general concept, over-dispersion occurs when the observed variability in data is greater than a model assumes. If present, it can make standard errors too small and uncertainty look narrower than it is when the model does not account for the extra variability. The primary endpoint is continuous, but no primary outcome distribution, model, or evidence about over-dispersion is reported in the registry record. It would therefore be inappropriate to claim that over-dispersion occurred or that a particular correction was used.

The registry also does not report an analysis plan, model specification, covariate adjustment, confidence intervals, or hypothesis tests for the primary outcome. The descriptive measure and the study design are known; the statistical procedures used to analyze any observed data are not reported in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Gelofusine 4%", "Gelaspan 4%")
n   <- c(121, 480)
m   <- c(14.58, 12.64)
sp  <- c(6.85, 4.72)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Gelofusine 4%  121  14.580  6.850  13.347  15.813
CARM  Gelaspan 4%  480  12.640  4.720  12.217  13.063

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 12 outcome measures, including the primary dosing measure, laboratory measures, and adverse events or reactions. It reports 0 analyses. A multiplicity strategy—such as identifying a hierarchy of outcomes, adjusting significance thresholds, or designating exploratory analyses—is not reported in the registry record. Without such information and without reported outcome estimates or tests, it is not possible to assess how multiple outcomes were handled or how any inferential claims should be interpreted.

Missing-data procedures are not reported in the registry record. The entry does not state how much outcome information was missing, whether missingness differed between product groups, or how incomplete measurements were treated. In general, missingness can affect both the composition of the analyzed sample and the interpretation of estimates; its consequences depend on why data are missing and on the method used to handle them. No conclusion about missing-data impact can be drawn from this record.

Analysis populations are also not reported in the registry record. It does not specify which participants contributed to the primary outcome analysis, whether the analysis included all enrolled participants, or how participants with incomplete data were handled. The enrollment figure is not an analysis denominator, and the safety denominators should not be assumed to apply to other outcomes. In general, clear definitions of analysis populations help readers understand which observations contribute to each result; that information is unavailable in the registry record.

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 serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: procedural hemorrhage (0.2%).

For Gelofusine 4%, the registry records 0 serious adverse events or reactions among 121 at risk, and 1 other adverse event or reaction among 121 at risk. For Gelaspan 4%, it records 1 serious adverse event or reaction among 480 at risk, and 3 other adverse events or reactions among 480 at risk. Deaths are recorded as 0 in each group. These are descriptive registry figures, not evidence of a tested difference between products.

The listed top serious adverse-event term is procedural hemorrhage, reported as 0.2%. The record does not provide a detailed account of the event or explain how the listed term relates to the group-level counts. The numbers at risk are the denominators attached to the respective safety summaries; they should not be treated as the analysis populations for the primary outcome or other measures.

As a general statistical point, adverse-event counts depend on how events are defined, collected, and attributed, as well as on the amount and duration of observation. The registry does not report enough detail to evaluate those aspects. Because this is a non-randomized observational study and allocation is not stated, the group figures cannot establish that one product caused more or fewer events than the other. The record also does not report an inferential safety comparison.

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

The record establishes that a completed non-interventional observational study collected information about Gelofusine 4% and Gelaspan 4% in children aged up to 12 years, with dosing during surgery as its primary outcome. It also identifies laboratory and adverse-event outcomes and provides limited safety counts. This is useful context about the study's aims and the types of information registered.

It does not establish the average dose or the variability of dosing, because the primary outcome results are not reported in the registry record. It does not report numerical results for the named laboratory outcomes. For safety, the posted counts can be described as recorded, but they do not show whether the groups differed beyond what might occur through chance or differences in the patients and care circumstances.

The study's observational character is central to interpretation. The registry states that it was not a randomized comparison and that allocation is not stated. Therefore, even if numerical group results were available, an unadjusted contrast would not automatically represent a causal effect of choosing one product rather than the other. The record does not provide a documented analysis that addresses potential differences between the groups.

Nor do planning illustrations establish the strength of the study's findings. They are described as calculations based on an observed effect and statistical assumptions, rather than as the study's own design justification. They cannot replace outcome estimates, uncertainty intervals, or an account of missing data and analysis populations.

In short, the registry supports a description of study purpose, design category, outcomes intended for collection, enrollment, and selected safety counts. It does not support a conclusion about comparative efficacy, dosing differences, or comparative safety. Missing primary and secondary results limit what can be learned from this registry entry, while the non-randomized design limits causal interpretation even where descriptive data are available.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of the distinction between collecting clinical-practice data and making a controlled treatment comparison. The registry's stated aim is to gather additional information on gelatine solutions in routine care. Such observational information can describe what was recorded in practice, but a comparison between product groups may also reflect how clinicians selected products and the circumstances of care. The record explicitly cautions that the arms are not a like-for-like control comparison.

The primary outcome is also a useful reminder that the outcome definition matters. Dosing is measured as a mean in ml/kg over a specified period relative to infusion, and the standard deviation is intended to describe variation. Those summaries would help characterize clinical practice if reported. Without them, enrollment alone cannot answer the primary question or indicate the precision of an estimate.

Safety counts have a different statistical structure from a continuous dosing measure. They record participants with serious or other adverse events or reactions, while the primary endpoint is a continuous quantity. Interpretation of event counts requires attention to the denominators, event definitions, and observation process. The available record gives some counts and a listed serious-event term, but does not report a comparative analysis or detailed event descriptions.

Finally, a planning illustration is conceptually distinct from evidence produced by an analysis. The record's stated assumptions describe planning calculations, not a randomized design or observed power. Recognizing that distinction helps prevent a sample-size calculation from being treated as proof that a study could detect a particular difference. The missing outcome summaries and analysis details are therefore important limits on what can be concluded.

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 most direct limitation of the registry entry is that it does not report the primary outcome results. Although dosing is defined as a mean and standard deviation in ml/kg, neither summary is available. The record also does not report numerical findings for the listed secondary laboratory outcomes. This prevents assessment of the observed values, their variability, and their precision.

The design is non-interventional and is not a randomized comparison. Allocation is not stated, and the record notes that the groups are not a like-for-like control comparison. No information is reported about factors that may have influenced product selection, participant comparability, or adjustment for such differences. These limitations prevent a causal interpretation of any simple group contrast.

Further methodological details are not reported in the registry record: the analysis plan, missing-data handling, analysis populations, measurement schedule beyond the stated timeframe, and inferential methods. The record does not explain how adverse events were defined, collected, or attributed, or give detailed descriptions of the listed serious event. The safety counts are therefore limited descriptive information.

Although planning assumptions are described, the registry does not report the numerical planning outputs or a prospective sample-size justification. It also lists 0 analyses. Together, missing outcome results and limited analytic detail mean the registry entry cannot establish the size or precision of a dosing difference, or a comparative safety or efficacy effect.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Gelatines in Pediatric PatientS — NCT02495285.
• Registry record last updated 2024-12-04; status last verified 2024-10.
• Results first posted 2024-12-04.
• 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

NCT02495285, “Gelatines in Pediatric PatientS,” is a completed non-interventional observational study sponsored by B. Braun Melsungen AG. It concerns children aged up to 12 years and records enrollment of 601. The study aim was to collect further information on gelatine solutions in routine clinical practice.

The products are Gelofusine 4% and Gelaspan 4%. The primary outcome is dosing during surgery, reported as a mean and standard deviation in ml/kg, over the timeframe before (0 - 2 h) and up to 2 h after infusion of gelatin solutions. The record lists 12 outcome measures and 0 analyses; primary and secondary outcome results are not reported in the registry record.

The registry identifies the study as non-randomized and states that allocation is not stated, so the product groups are not a like-for-like control comparison. Safety counts are recorded for serious and other adverse events or reactions, with 0 deaths in each group. Those figures are descriptive and do not establish a comparative effect.