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 A Multi-Center Study of a SCD for Immunomodulatory Dysregulation in Pediatric AKI (NCT04869787), a na na study. The primary outcome is Number of SCD-related Adverse Events (AE).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04869787 |
| Phase | NA |
| Condition | Acute Kidney Injury |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 7 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Children's Hospital Medical Center, Cincinnati |
| Results posted | Yes |
2. Clinical Question
Population
Pediatric patients with acute kidney injury (AKI) who received treatment with the Selective Cytopheretic Device (SCD). The registry record lists 7 enrolled participants; the safety results list 6 participants at risk.
Intervention
SCD treatment used with continuous renal replacement therapy (CRRT), for up to 10 days. The study description proposes up to ten sequential 24-hour SCD treatments.
Comparator
No concurrent comparator arm is listed. The study is recorded as a single-group trial with allocation listed as NA. The brief summary describes a planned comparison with historical controls who received CRRT alone, but a comparative analysis is not reported in the registry record.
Primary question
How many adverse events considered at least possibly related to SCD therapy occurred across treated participants, from enrollment through Day 60 post treatment? The registry record describes this as the primary safety measure. It also states an intended hypothesis about safety and survival relative to historical controls, but does not report a comparative survival result.
The study concerns a proposed device-based approach to inflammatory dysregulation in pediatric AKI. The brief summary describes activated circulating leukocytes as part of the inflammatory process and says that the SCD is intended to bind activated leukocytes when used in a CRRT circuit with regional citrate anticoagulation. Those statements describe the study rationale; they are not outcome findings. The record identifies mortality and renal recovery, along with hospital and intensive care unit length of stay, among the secondary outcomes. It does not report comparative estimates for those outcomes.
3. Trial Design
This was a multicenter pilot study of the Selective Cytopheretic Device in pediatric acute kidney injury. The registry lists the phase as NA, allocation as NA, masking as none, and the model as single group. The intervention arm is described as pediatric patients receiving SCD plus continuous renal replacement therapy for up to 10 days. The brief summary describes a plan for up to ten sequential 24-hour treatments.
The registry lists an enrollment of 7. The study began on 2021-05-17, reached primary completion on 2023-10-27, and is recorded as terminated. The reason for termination is not reported in the registry record. Nor is the planned enrollment target or the reason for selecting it reported in the registry record.
The brief summary describes the primary hypothesis as completing SCD treatments safely and improving survival compared with historical controls treated with CRRT alone. That statement describes the intended question, not a reported controlled comparison. The design information lists a single group, and no historical-control results or adjusted comparison are reported in the registry record. Therefore, the posted trial results do not establish a treatment contrast against CRRT alone.
The registry lists 8 outcome measures and 0 analyses. The primary outcome is a count of SCD-related adverse events. Mortality, renal recovery, hospital length of stay, and intensive care unit length of stay are among the listed secondary outcomes; mortality and renal recovery appear more than once in the listing. The record does not explain those repeated entries. The safety results identify 6 participants at risk, while enrollment is listed as 7; the reason for that difference is 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.
Before assignment: After consent was obtained, participants entered the screening period. If their clinical status changed and the investigator believed that they no longer met eligibility criteria, the participant would be recorded as a screen failure. Criteria this may impact included resuscitation status, hypotension, platelet count, medical condition that the investigator thought would interfere with study objectives. or treating physician believed it was not longer in the patient's best interest.
Screening
| Stage | SCD Treatment |
|---|---|
| STARTED | 7 |
| COMPLETED | 6 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | SCD Treatment |
|---|---|
| Physician Decision | 1 |
SCD Treatment Period (up to 10 Days)
| Stage | SCD Treatment |
|---|---|
| STARTED | 6 |
| COMPLETED | 5 |
| NOT COMPLETED | 1 |
Reasons for not completing this period:
| Reason | SCD Treatment |
|---|---|
| Death | 1 |
Observational Follow Up Period (90 Days)
| Stage | SCD Treatment |
|---|---|
| STARTED | 5 |
| COMPLETED | 5 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Participants who received treatment with the SCD
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.
Population: Participants who went on to receive treatment with the SCD
| Characteristic | Unit | SCD Treatment |
|---|---|---|
| Participants analysed | 6 | |
| Age, Continuous | years | 2.05 (1.77 to 3.48) |
| Sex: Female, Male: Female | Participants | 2 |
| Sex: Female, Male: Male | Participants | 4 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 1 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 5 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 5 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Body Weight, Continuous | kilograms | 13.4 (12.0 to 14.1) |
| Pediatric Risk of Mortality II Score | Scores on a scale | 16.5 (14 to 20) |
6. Primary Endpoint
The registry lists the primary outcome as Number of SCD-related Adverse Events (AE), measured over From enrollment to Day 60 post treatment.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Events |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the total number of adverse events across participants that the site investigator considered at least possibly related to SCD therapy. Its stated timeframe runs from enrollment to Day 60 post treatment, and its population is participants who received SCD treatment. The measure is expressed as a number of events, rather than as a time-to-event outcome or a comparison between treatment groups.
A safety count can describe the observed burden of events considered potentially related to the device. It can be useful in a pilot study because it records events that occur during or after treatment and captures the investigator’s attribution judgment. That judgment is not the same as proof that the device caused an event. The endpoint also does not, by itself, describe how severe each event was, whether an individual experienced more than one event, or how the count compares with another treatment.
The registry record does not report the primary endpoint’s total event count. It also does not report a participant-level distribution, an uncertainty interval, or an analysis of the endpoint. Consequently, the endpoint definition is available, but its observed value and precision are not reported in the registry record. The separate serious-adverse-event figures should not be substituted for the primary endpoint: they describe participants with serious events and do not give the total number of events judged at least possibly related to SCD therapy.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available results offer limited descriptive safety information, but they do not provide the primary endpoint result. The registry defines that endpoint as the total number of adverse events considered at least possibly related to SCD therapy across treated participants through Day 60 post treatment. The total is not reported in the registry record. Without that value, its distribution across participants, or an uncertainty estimate, the primary safety question cannot be assessed from the posted results.
The adverse-event summary lists 6 participants at risk for serious adverse events and 2 affected. It also lists 6 participants at risk for other adverse events and 5 affected. These are descriptive participant counts. They do not establish how many events occurred in total, whether the same participant experienced events in both categories, or whether any event was judged related to SCD. One death is listed, but its relationship to treatment is not reported in the registry record.
The serious-event terms are each listed with a percentage of 16.7%: pneumothorax, medical device site thrombosis, cardiac arrest, septic shock, acute respiratory failure, and lactic acidosis. The record does not provide a narrative account of the events, their timing, their outcomes, or whether the terms occurred in the same or different participants. These terms and percentages should therefore be read as entries in a safety listing, not as a comparative estimate or a measure of treatment effect.
The study has no concurrent comparator in the recorded design. Although the brief summary describes a proposed comparison with historical controls, comparative results are not reported in the registry record. It is therefore not possible to attribute differences in mortality, renal recovery, length of stay, or adverse events to the SCD from these results. The registry lists those clinical outcomes, but does not report their analyses or estimates.
General statistical interpretation requires attention to both the size of an observed estimate and its uncertainty. In a small pilot, any event count can be sensitive to the experience of individual participants; a confidence interval, when available, would express uncertainty around an estimate rather than guarantee that the true value lies in a particular range. No such interval is reported for the primary endpoint. The small enrollment and the absence of a reported comparative analysis mean that the results are best treated as descriptive registry information, not as a precise estimate of safety or efficacy.
9. Statistical Methods Explained
The recorded design is single group, with allocation listed as NA and masking listed as none. In a single-group study, participants receive the study intervention without a concurrent randomized control group. This design can describe what happened among treated participants, but it cannot isolate the intervention’s effect from the course of illness, other care, or differences in patient characteristics. The brief summary mentions historical controls receiving CRRT alone as the intended reference for a survival hypothesis; a historical comparison is not reported in the posted results.
What does a count endpoint represent?
The primary outcome is a count: the total number of adverse events judged at least possibly related to SCD therapy across participants. A count differs from a participant-level binary outcome such as whether a participant experienced at least one event. One participant may have more than one event, so an event total and the number of affected participants answer different questions. The registry defines the event count but does not report its observed value or how many participants contributed events.
General statistical explanation: count data are nonnegative and may be unevenly distributed, especially when some participants experience more events than others. A statistical model for counts may need to account for variation beyond what a simple count model expects, often called over-dispersion. That concern cannot be evaluated from the posted endpoint information because the event total and participant-level distribution are not reported. The registry record does not report a model or statistical plan for the primary endpoint.
What can the safety summary establish?
The safety summary reports participants at risk and participants affected for serious and other adverse events. Those counts are descriptive and use participants, not total events, as their unit. The primary endpoint instead counts events considered at least possibly related to SCD therapy. Because the endpoint definitions and units differ, the serious-adverse-event figures cannot supply the missing primary endpoint result. Nor do the participant counts show comparative risks: no concurrent control group is listed.
General statistical explanation: a confidence interval communicates the precision of an estimate by showing a range of values compatible with the data under the method’s assumptions. A point estimate without an interval can obscure substantial uncertainty, particularly in a small study. The registry record does not report a confidence interval or other uncertainty measure for the primary endpoint, and it does not report a test of a treatment effect.
How should the planning illustrations be understood?
The planning assumptions describe illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The intended effect is specified as a stated fraction of the observed effect. These assumptions describe a hypothetical planning exercise; they do not describe the recorded single-group design. They also do not establish that the trial was planned with those assumptions.
General statistical explanation: sample-size calculations depend on the outcome, target effect, variability, significance level, allocation, and analysis method. Changing the assumed effect changes the sample size needed to detect it under those assumptions. A calculation based on an observed effect is a planning illustration, not an observed-power result and not evidence that the study was adequately powered. The registry record does not report the trial’s own sample-size justification. No numerical sample-size estimate is because the planning estimates are not stated in the registry record available for this analysis.
The registry lists 0 analyses. No inferential method, covariate adjustment, interim analysis, or approach to repeated observations is reported in the registry record. No assumptions about those procedures should be inferred from the trial’s pilot designation or from the planning assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 8 outcome measures, including mortality, renal recovery, hospital length of stay, and intensive care unit length of stay. Mortality and renal recovery appear more than once in the outcome listing. The record does not explain whether repeated entries reflect distinct definitions, timeframes, or reporting duplication. It also does not identify a hierarchy among secondary outcomes or describe how multiple outcome questions were handled.
General statistical explanation: examining several outcomes can increase the chance of at least one apparently notable result arising by chance when each is tested separately. A prespecified hierarchy or multiplicity adjustment can address that issue, but neither approach is reported in the registry record. Since 0 analyses are listed, there are no reported test results to interpret as a family of statistical comparisons.
Missing-data procedures, participant flow after enrollment, and reasons for any unavailable outcome measurements are not reported in the registry record. Enrollment is listed as 7, while the safety summary lists 6 participants at risk. The record does not explain that difference, so it cannot be attributed to withdrawal, ineligibility, incomplete follow-up, or any other reason. The timeframe for the primary endpoint is stated, but completeness of follow-up through Day 60 post treatment is not reported.
The primary endpoint population is described as participants who received SCD treatment. The safety summary separately gives its at-risk count. The registry does not report a detailed analysis-population definition, a participant disposition, or whether all enrolled participants received treatment. No intention-to-treat analysis or other analysis-population strategy is reported in the registry record.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| SCD Treatment | 2 | 6 | 33.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| SCD Treatment | 1 of 6 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| SCD Treatment | 5 of 6 |
Most frequent serious adverse event terms
| Event term | Organ system | SCD Treatment |
|---|---|---|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | 1 of 6 |
| Medical device site thrombosis | Injury, poisoning and procedural complications | 1 of 6 |
| Cardiac arrest | Cardiac disorders | 1 of 6 |
| Septic shock | Infections and infestations | 1 of 6 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 1 of 6 |
| Lactic acidosis | Metabolism and nutrition disorders | 1 of 6 |
Most frequent non-serious adverse event terms
| Event term | Organ system | SCD Treatment |
|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | 3 of 6 |
| Hypokalemia | Metabolism and nutrition disorders | 3 of 6 |
| Hyperbilirubinemia | Hepatobiliary disorders | 2 of 6 |
| Hypophosphatemia | Metabolism and nutrition disorders | 2 of 6 |
| Anemia | Blood and lymphatic system disorders | 1 of 6 |
| Coagulopathy | Blood and lymphatic system disorders | 1 of 6 |
| Blood bicarbonate decreased | Investigations | 1 of 6 |
| Blood fibrinogen decreased | Investigations | 1 of 6 |
| White blood cell count increased | Investigations | 1 of 6 |
| Hypercalcemia | Metabolism and nutrition disorders | 1 of 6 |
Serious events with the highest arm-level rate: pneumothorax (16.7%), medical device site thrombosis (16.7%), cardiac arrest (16.7%), septic shock (16.7%), acute respiratory failure (16.7%).
The serious-adverse-event summary lists 6 participants at risk and 2 affected. The other-adverse-event summary also lists 6 participants at risk, with 5 affected. These counts describe participants, not the total number of events. The registry also lists 1 death, without reporting its relationship to treatment. It does not state whether any participant contributed to more than one category.
Six serious-event terms are listed, each with a percentage of 16.7%: pneumothorax, medical device site thrombosis, cardiac arrest, septic shock, acute respiratory failure, and lactic acidosis. The registry record does not supply additional event-level details or explain the denominator and counting rules for each term. The percentages should be read as the registry’s listed values, not converted into event counts or added together to estimate a total. A participant may have multiple event terms, and the listing does not say whether the terms represent distinct people.
Seriousness, occurrence, and relatedness are different concepts. The primary endpoint concerns events judged at least possibly related to SCD by the site investigator; the serious-event listing does not identify which events met that relatedness criterion. These safety figures therefore do not provide the missing primary endpoint count or establish that the device caused any listed event.
12. What the Result Does, and Does Not, Mean
The registry record documents a pilot study of SCD treatment with CRRT in pediatric AKI and includes a limited adverse-event summary. It reports 7 enrolled participants, while the safety summary lists 6 at risk. Among the safety results, 2 participants are listed as affected by serious adverse events and 5 by other adverse events, with 1 death listed. The record also lists serious-event terms and their percentages.
Those observations do not answer the primary endpoint question, because the total number of events considered at least possibly related to SCD therapy is not reported in the registry record. The posted safety counts also do not establish causation, comparative risk, or the clinical course of any individual participant. A relatedness assessment is not equivalent to proof of causation, and the death’s relationship to treatment is not reported.
The brief summary states an intended hypothesis about survival relative to historical controls, but the recorded design is single group and comparative results are not reported. The record therefore does not show whether SCD treatment changed survival, renal recovery, length of stay, or any other clinical outcome. The listed secondary outcomes cannot be interpreted as evidence of benefit or harm without their results and an appropriate comparison.
General statistical explanation: a pilot study can contribute descriptive information and help identify questions for further study, but a small, uncontrolled dataset typically leaves substantial uncertainty about both event rates and treatment effects. The registry record does not report a precision estimate for the primary endpoint or a controlled effect estimate. The findings should be understood as incomplete descriptive safety information rather than a definitive evaluation of safety or efficacy.
13. Why This Trial Matters Statistically
This study is statistically important because it illustrates the difference between a trial’s intended hypothesis and the results available for interpretation. The brief summary describes a survival hypothesis against historical controls, while the recorded design is single group and the registry does not report a comparative analysis. A stated intention to compare does not itself produce an estimate of a treatment effect.
The primary endpoint also highlights the difference between an event count and the number of participants affected. The registry defines a total count of events considered at least possibly related to SCD, but the reported safety summary gives participants at risk and participants affected. Those summaries answer different questions. Keeping the unit of analysis clear prevents participant counts from being mistaken for event totals or for a treatment-related endpoint result.
The distinction between safety descriptions and causal conclusions is also central. The site investigator’s judgment that an event is at least possibly related is a defined attribution category, not a randomized estimate of harm. Without a concurrent comparator, event counts cannot distinguish treatment effects from events associated with the underlying illness or other care.
Finally, the record exposes practical limits on inference: the primary event count, analysis methods, sample-size justification, and explanation for the difference between enrollment and the safety at-risk count are not reported. The study may still offer useful context as a pilot, but the registry record leaves key quantities needed to judge the endpoint’s magnitude and precision unavailable.
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 principal limitation is that the registry record does not report the primary endpoint’s event total. It defines the endpoint and timeframe, but does not provide an estimate, participant-level distribution, or uncertainty measure. As a result, the central safety measure cannot be interpreted quantitatively from the posted results.
The trial is recorded as a single group, with no concurrent control arm. Although historical controls are mentioned in the brief summary, no historical-control data or comparative analysis is reported. This limits assessment of whether any observed events or clinical outcomes differ from what might occur under CRRT alone.
The registry lists 7 enrolled participants and a safety at-risk group of 6, without explaining the difference. It does not report participant disposition or the completeness of follow-up through Day 60 post treatment. The reason for the terminated status is also not reported in the registry record.
Important details for interpreting safety are absent, including event timing, outcomes, participant overlap among event categories, and which serious events were considered possibly related to SCD. The relationship of the listed death to treatment is not reported. The record also does not report statistical methods, missing-data procedures, a sample-size justification, or how multiple outcome measures were handled.
These limitations are specific to the information recorded for this trial and leave substantial uncertainty around both the safety endpoint and the intended survival question. They do not establish that an unreported analysis was or was not performed outside the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Multi-Center Study of a SCD for Immunomodulatory Dysregulation in Pediatric AKI — NCT04869787.
- Registry record last updated 2024-01-10; status last verified 2023-12.
- Results first posted 2024-01-10.
- 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.
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18. Record Summary
NCT04869787 is a terminated, multicenter, single-group pilot study of the Selective Cytopheretic Device with continuous renal replacement therapy for pediatric acute kidney injury. The registry lists 7 enrolled participants, no masking, and a primary safety endpoint defined as the total number of adverse events considered at least possibly related to SCD through Day 60 post treatment.
The safety results list 6 participants at risk for serious adverse events and 2 affected, 6 at risk for other adverse events and 5 affected, and 1 death. Six serious-event terms are listed, each at 16.7%. The primary endpoint total and comparative clinical results are not reported in the registry record. The record lists 8 outcome measures and 0 analyses. It does not report the reason for termination, the trial’s sample-size justification, or an explanation for the difference between enrollment and the safety at-risk group.