Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI). (NCT02820350), a na na study. The primary outcome is Adverse Events.

2. Clinical Question

The study concerns use of the Selective Cytopheretic Device (SCD) in pediatric patients with acute kidney injury (AKI). The registry describes the device as an adjunct to renal replacement therapy (RRT), and identifies SCD-F40 as the intervention. The central clinical question is whether adverse events related to SCD treatment occurred during treatment and through 60 days after treatment initiation. The record also lists mortality and RRT dependency outcomes, but does not report numerical results for those secondary outcomes.

This structure makes the study primarily a description of experience in a treated group, rather than a randomized test of outcomes against a control group. It can document the events recorded among participants with available safety data, but it cannot by itself separate events associated with treatment from events arising from AKI, RRT, or other circumstances. The registry record does not report detailed eligibility criteria, participant characteristics, or a comparator capable of addressing those questions.

3. Trial Design

The registry describes a multicenter pilot study of SCD in pediatric patients with AKI. It is marked completed, with a recorded enrollment of 19. The recorded study start date is 2016-12-04 and the primary completion date is 2020-03-31. The listed intervention is the SCD-F40 device, and the arm description identifies a treatment arm only.

The design is classified as single-group. Allocation is recorded as NA and masking as none. Accordingly, the registry record does not describe random assignment or a masked comparison, and it does not give a concurrent control group. Results from the treated group therefore need to be read as descriptive observations rather than as a randomized estimate of what would have happened under an alternative treatment.

The primary outcome is titled “Adverse Events” and is defined as adverse events related to device treatment during and 60 days after treatment initiation. The listed secondary outcomes are all-cause mortality through 60 days post-randomization, mortality at Day 28, and RRT dependency at Day 60. The record does not give numerical results for these secondary outcomes. Nor does it report outcome analyses, with the analysis count recorded as 0.

Although 19 participants are listed as enrolled, the safety summary reports 16 at risk for serious adverse events and 16 at risk for other adverse events. The registry does not explain why the safety denominators differ from enrollment, whether the same participants contributed to both summaries, or what happened to participants without reported safety data. Those details should not be inferred from the design description alone.

The pilot designation signals that the study is described as an early, limited investigation; it does not establish a particular statistical objective or justify a claim of effectiveness. The protocol’s sample-size justification, planned interim analyses, and detailed statistical analysis plan are not reported in the registry record.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Adverse events related to SCD treatment up to 60 days following treatment initiation

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 Adverse Events, measured over 60 days post treatment initiation.

The primary endpoint is titled “Adverse Events.” Its definition covers adverse events related to device treatment occurring during treatment and through 60 days after treatment initiation. The endpoint is expressed as a number of adverse events, rather than as a measure of symptom improvement or a comparative treatment effect. The record describes the population for this outcome as adverse events related to SCD treatment up to 60 days following treatment initiation.

Safety outcomes are important in a pilot study of a device because they describe the adverse experiences recorded during exposure and the period specified by the registry. A fixed follow-up window also defines the period within which the event information is intended to be collected. General statistical point: an event count and the number of participants experiencing at least one event are different quantities. A participant may experience more than one event, so a count of events cannot automatically be interpreted as a count of affected participants, or vice versa.

The registry record does not give a numerical value for the primary endpoint itself. Its separate adverse-event summary reports participants at risk and participants affected for serious and other adverse events. Those summaries describe the safety information available in the record, but they should not be treated as an event tally unless the record explicitly identifies them as such. The outcome definition does not establish whether events were independently adjudicated, how relatedness was assessed, or how recurrent events were handled; these details are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry classifies the study as single-group, with one treatment arm and no reported comparator. Allocation is listed as NA and masking as none. These design features determine what statistical interpretation is possible. Because there is no randomized contrast, the reported safety experience can be described within the treated group, but it cannot serve as a randomized estimate of the effect of SCD relative to a control treatment.

What does a count outcome represent?

The primary endpoint is expressed as a number of adverse events. A count outcome records how many events meet the outcome definition during the specified follow-up. General statistical explanation: counts may be analyzed as total events, as event rates relative to follow-up time, or through another model suited to the study question. Those approaches answer different questions and require different information. The registry record does not report a numerical primary-endpoint count, an event rate, person-time, or an analysis model.

The safety summary separately reports the number at risk and the number affected for serious and other adverse events. These figures describe participants with an event, not necessarily the number of events. General statistical explanation: if a participant has recurrent events, the event count can exceed the number of affected participants. A participant-level summary also does not describe when events occurred or how often they recurred. The registry record does not provide those details.

Why does the study design matter?

In a single-group study, observed outcomes are not paired with outcomes from a concurrent control group. General statistical explanation: a control group can help distinguish changes or event patterns associated with an intervention from patterns that might occur because of disease course, background care, or other factors. Random allocation, when used, can improve the fairness of that comparison by balancing known and unknown factors on average. Neither a randomized comparison nor a control arm is reported for this study. Thus, even a precise description of events among treated participants would not, on its own, estimate a comparative treatment effect.

The registry identifies the study as a pilot, but does not report a statistical objective that explains whether the design was intended primarily to assess feasibility, safety, or an effect estimate. The protocol, sample-size justification, planned interim analyses, and detailed statistical plan are not reported in the registry record. Their absence means the observed enrollment cannot be judged against a stated power or precision target.

How should precision be assessed?

A confidence interval is a general statistical tool for expressing uncertainty around an estimate. It gives a range of values compatible with the data under the assumptions of the method; it is not a guarantee that the true value lies within that particular interval. A narrow interval indicates greater precision than a wide interval, while neither width establishes that a result is free from bias. The registry record does not report a confidence interval for the primary endpoint or the listed secondary outcomes, so their statistical precision cannot be evaluated from the record.

General statistical explanation: count outcomes can vary more than a simple Poisson model expects when events cluster within participants or when participants have different underlying event rates. This extra variability is called over-dispersion. A model that allows for over-dispersion can yield uncertainty estimates more appropriate to such data. The registry record does not identify an event-count model or give data that would establish whether over-dispersion was present. It would therefore be inappropriate to claim that a particular model was used or required in this analysis.

What can the listed safety summaries support?

The serious and other adverse-event figures support a description of how many participants were reported as affected among those at risk in each category. The serious-event terms and associated percentages provide additional descriptive detail, but the denominator and calculation method for the percentages are not reported. The figures do not establish event timing, recurrence, severity grading beyond the serious/other distinction, or a causal relationship to the device. The endpoint definition refers to events related to SCD treatment, but the method used to determine relatedness is not described.

There are no reported analysis results in the registry record, and it does not give a p-value or adjusted estimate. General statistical explanation: adjusted analyses account for selected covariates, while unadjusted analyses do not; neither approach can compensate for the absence of a comparison group when the question requires a treatment contrast. No such analysis details are reported. The numerical summaries should therefore be interpreted as descriptive safety information, with the design and reporting limits kept in view.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary adverse-event endpoint and three secondary outcomes: all-cause mortality through 60 days post-randomization, mortality at Day 28, and RRT dependency at Day 60. It does not report numerical results for these secondary outcomes. The analysis count is recorded as 0, and the statistical plan, any adjustment for multiple testing, and any hierarchy for interpreting outcomes are not reported in the registry record.

Multiplicity is a general statistical concern that arises when several outcomes or comparisons are tested. The more tests conducted, the greater the chance that at least one result may appear notable by chance alone, unless the analysis plan accounts for the testing structure. The registry does not say whether formal hypothesis tests were conducted or how multiple outcomes would be handled. There is therefore no basis for describing an adjustment or interpreting the listed secondary outcomes as confirmatory statistical tests.

The registry reports 19 enrolled, while the safety summaries list 16 at risk for serious events and 16 at risk for other events. It does not explain the difference, state whether any data were missing, or describe how missing observations were handled. Reasons for missing data, follow-up completeness, and an analysis population definition are not reported in the registry record. No assumption about the outcomes of participants without a reported safety denominator should be made.

General statistical explanation: missing outcomes can affect interpretation when the likelihood of missingness is related to health status or the outcome itself. Complete-case summaries describe the participants with available data, but may not represent the enrolled group if missingness is systematic. The registry record does not provide enough information to assess this issue or to determine whether an imputation or sensitivity analysis was performed.

11. 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 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: cardio-respiratory arrest (25.0%), pneumoperitoneum (18.8%), nephrolithiasis (6.2%), stevens-johnson syndrome (6.2%), cerebral hemorrhage (6.2%).

The adverse-event summary reports serious events for 8 of 16 participants at risk and other adverse events for 14 of 16 participants at risk. The categories should be kept separate as reported; the registry does not describe their overlap. It also lists 4 deaths. The record does not clarify whether the deaths are included among participants affected by serious events, so they should not be added to or subtracted from those figures.

Several serious-event terms have percentages attached: Cardio-respiratory arrest, 25.0%; Pneumoperitoneum, 18.8%; and Nephrolithiasis, Stevens-Johnson syndrome, Cerebral Hemorrhage, and Adrenal Insufficiency, each at 6.2%. The denominator and calculation method for these percentages are not reported in the registry record. They should not be treated as a complete account of every event or as estimates that can be compared with another group.

The endpoint definition refers to adverse events related to SCD treatment. The available summary does not explain how relatedness was assessed, how event terms were classified, or whether recurrent events were counted separately. These safety figures are descriptive observations from a single-group study. They do not establish that the device caused an event, nor do they show how event frequency would compare under another treatment.

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

The record documents a completed, single-group pilot study of SCD-F40 in pediatric patients with AKI. It gives participant-level safety summaries for serious and other adverse events, identifies serious-event terms, and lists deaths. Those data describe the events recorded in the treated group among participants included in the safety denominators. They are useful as a record of the reported safety experience, subject to the limits of the available detail.

The record does not report a numerical result for the primary endpoint, which is defined as the number of adverse events related to device treatment through 60 days after treatment initiation. The participant-level safety summaries do not substitute for that event count. It also does not report results for the listed mortality and RRT dependency outcomes. As a result, the registry information does not provide a complete numerical assessment of the outcomes specified in the record.

The single-group design also sets a firm boundary on interpretation. There is no concurrent control group against which to compare observed event experience, mortality, or RRT dependency. Consequently, the record cannot establish whether an outcome was caused by the device, was more or less frequent than under an alternative, or reflects the course of AKI and associated care. It does not establish efficacy or comparative safety.

Absence of a confidence interval or other uncertainty estimate makes it impossible to judge the precision of a primary-outcome estimate from this registry record. The difference between enrollment and the safety denominators is unexplained, and the denominator for the term-specific percentages is not reported. These reporting gaps limit assessment of completeness and uncertainty. They should not be filled by assumptions.

In general, a pilot study can contribute descriptive information and help frame questions for later evaluation, but a pilot label alone does not specify the trial’s aims or prove that it was designed to answer a particular efficacy question. The record does not report its sample-size justification or detailed analysis plan. The most defensible interpretation is therefore narrow: the registry records adverse-event experience in a treated group, while leaving comparative effects and several prespecified outcomes unresolved.

13. Why This Trial Matters Statistically

This trial is statistically notable because the registry pairs a defined safety endpoint with a single-group design. That combination emphasizes the importance of distinguishing description from comparison. The reported safety figures describe participants with recorded events, but without a concurrent control group they cannot tell whether those event patterns differ from what would occur under another treatment or in the absence of SCD.

The record also makes visible a common issue in reading clinical-trial results: the outcome label and the available numerical summaries may refer to different quantities. The primary endpoint is a number of adverse events, while the safety summary gives the number affected among those at risk. General statistical explanation: event counts and affected-participant counts have different interpretations, particularly when repeated events are possible. Keeping those measures distinct prevents a participant summary from being mistaken for a complete event tally.

The safety denominators are not the same as the recorded enrollment, and the registry does not explain why. That gap matters because readers need to know which participants contributed outcome information and whether the available observations represent the enrolled group. The record also does not specify the denominator for percentages accompanying serious-event terms, limiting interpretation of those percentages.

Finally, the registry lists secondary outcomes but does not report their numerical results or outcome analyses. The record does not describe how multiple outcomes were to be analyzed, the statistical plan, or the sample-size rationale. These omissions make it difficult to assess the intended inferential framework. The study therefore illustrates why design, endpoint definition, denominators, and reporting completeness must be considered together when interpreting clinical trial statistics.

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 main limitation is the absence of a concurrent comparator. Because the study is single-group, the registry cannot support a controlled estimate of the effect of SCD-F40. Events observed in the treated group may reflect the device, AKI, RRT, other circumstances, or a combination; the record does not separate these possibilities.

The primary endpoint is defined, but its numerical result is not reported. The separate safety summary gives affected-participant figures rather than a stated total event count. The registry does not explain the relationship between those summaries and the primary endpoint, or how event relatedness was assessed. The listed secondary outcomes also lack reported numerical results.

The safety denominators are 16 at risk for serious adverse events and 16 at risk for other adverse events, whereas enrollment is 19. The record does not explain the difference or describe missing data and follow-up completeness. It also does not report participant characteristics, so the reader cannot assess how closely the study group represents a more specific pediatric population.

The serious-event term percentages have no reported denominator or calculation method. The record does not give confidence intervals, p-values, analysis methods, or detailed statistical plans. It also does not describe event timing, recurrence, or the relationship between the reported deaths and serious adverse events. These are limits of the registry record; explanations for them are not reported and should not be inferred.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI). — NCT02820350.
• Registry record last updated 2024-06-20; status last verified 2024-06.
• Results first posted 2024-06-20.
• 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.

18. Record Summary

The registry record describes a completed, multicenter pilot study of SCD-F40 in pediatric patients with AKI. It lists 19 enrolled, a single treatment group, no masking, and no randomized allocation. The device is described as an adjunct to RRT.

The primary endpoint is adverse events related to device treatment during treatment and through 60 days after initiation. The record lists secondary outcomes for mortality and RRT dependency, but does not report their numerical results. The primary endpoint’s numerical result and the statistical analysis plan are also not reported.

The safety summary reports 8 of 16 participants at risk affected by serious adverse events and 14 of 16 affected by other adverse events, with 4 deaths listed. Serious-event terms include accompanying percentages whose denominator is not reported. With no comparator and unexplained differences in denominators, these results are descriptive and do not establish comparative safety or efficacy.