Evaluation of Trima Version 7.0 Platelets in PAS: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Evaluation of Trima Version 7.0 Platelets in PAS (NCT02754440), a non-randomized na study. The primary outcome is Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level.

2. Clinical Question

The trial asked whether platelet products collected using the Trima Accel system with Version 7.0 software enhancements met specified residual white blood cell (WBC) criteria. The endpoint concerned acceptable residual WBC levels in products collected from healthy adult volunteer blood donors. The registry describes single, double, and triple platelet products, with product-specific acceptance thresholds, and states that assessment occurred within 48 hours of the end of donation.

The registry’s stated purpose was to verify that the collected and stored platelets met FDA requirements for leukoreduction. Its brief summary gives a threshold for a transfusable unit, while the primary endpoint description specifies separate criteria for single, double, and triple products. The registry record does not report the primary endpoint counts or the results by product category. Therefore, the research question and its operational criteria can be described, but the observed endpoint outcome cannot be assessed from the record.

3. Trial Design

This was a completed, nonrandomized, parallel study with no masking. The registry lists an enrollment of 365 and identifies the participants as healthy volunteers. The study started on 2016-04-20, reached primary completion on 2017-07-28, and has a completed status. The listed phase is NA.

The intervention was the Trima Accel system with Version 7.0 software. Participants who qualified for single, double, or triple platelet collection underwent plateletpheresis in the corresponding product category. The registry describes concurrent plasma collection in 25% of collections in each category. These categories organize the product type and the applicable endpoint criteria; the registry explicitly notes that the arms are not a like-for-like control comparison.

Because allocation was nonrandomized and no masking was used, the design does not support the same direct treatment comparison as a randomized, blinded trial. In particular, differences between product categories would not, by themselves, isolate an effect of software or collection type: the groups represent different collection qualifications and products, and the registry does not describe randomized assignment between them. The record does not report further details about how participants were assigned to product categories.

The Full Analysis Set included participants who completed the study and did not meet any protocol exclusion criteria. A participant could contribute only one product to that set. The registry states that this population was used for primary and secondary endpoints. A secondary outcome concerned the number of participants with platelet units containing an acceptable platelet yield. The registry lists two outcome measures and six analyses, but does not report a detailed statistical analysis plan in the information available. In particular, the allocation description, masking status, and outcome definitions do not establish what statistical models or adjustment procedures were used.

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: 365 participants consented/enrolled: 25 screen-failed; 5 never started procedure = 30 participants excluded from Safety Analysis. 335 participants = Safety Analysis set (56 participants excluded from the full analysis set: 35 participants were "unassigned" to an Arm, 21 participants were assigned to an Arm) 279 = Full Analysis set

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.

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: Safety Analysis Set = Includes all Subjects that had an apheresis procedure started.

6. Primary Endpoint

The registry lists the primary outcome as Number of Participants With Platelet Units Containing an Acceptable Residual WBC Level, measured over Within 48 hours of end of donation.

The primary endpoint is the number of participants with platelet units containing an acceptable residual WBC level. It is a count of participants meeting a product-specific criterion, rather than a continuous measurement of WBC concentration or a time-to-event outcome. The assessment timeframe was within 48 hours of the end of donation.

The registry defines acceptable residual WBC counts differently by product. For single products, the criterion is residual WBC level < 5.0 × 10^6. For double products, it is < 8.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit. For triple products, it is < 12.0 × 10^6 or < 5.0 × 10^6 for each transfusable unit. The brief summary states the intended leukoreduction requirement as < 5.0 × 10^6 residual WBC per transfusable unit.

This endpoint translates a technical product characteristic into a binary participant-level outcome: each participant either had a product meeting the stated criterion or did not, according to the endpoint definition. Such an endpoint can directly address whether collected units satisfy a specified acceptance threshold. However, the registry record does not report the number meeting the criterion, the number assessed, or the result by product type. Without those results, it is not possible to describe the observed level of endpoint attainment or its precision.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a binary participant-level count: participants are counted according to whether their platelet units meet the applicable residual WBC criterion. In general, binary outcomes simplify a measurement into categories such as meeting or not meeting a threshold. That makes the result easy to relate to an acceptance rule, but it also means the count alone would not show how far measurements were from the threshold. The registry record does not report the underlying WBC measurements or primary outcome counts.

What does a count-based endpoint tell the reader?

A count of participants meeting an endpoint can describe how often a defined event occurred in the analyzed population. Its interpretation depends on knowing both the number meeting the criterion and the number assessed. The latter is essential context because the same count can have different meanings in populations of different sizes. For this trial, the registry gives the Full Analysis Set definition but does not report its size or the primary endpoint numerator. The overall enrollment cannot be assumed to equal the analyzed population.

The endpoint is tied to three product categories, each with its own stated acceptance criterion. Such criteria make the outcome operational: a product is assessed against a threshold that depends on whether it is a single, double, or triple collection. Because the thresholds differ, a raw comparison of counts across categories would not automatically be a fair comparison of performance. A comparison would need to account for the distinct criteria and the way participants entered each category. The registry record does not report a comparative analysis that would answer that question.

Why does the nonrandomized design matter?

In general, random allocation helps balance measured and unmeasured characteristics between comparison groups, on average. A nonrandomized design does not obtain that protection by design. This trial is listed as nonrandomized, and the registry explicitly warns that its arms are not a like-for-like control comparison. The product categories describe different collection types, so their results should not be treated as if they were randomized treatment arms. Any comparison would be descriptive unless a suitable analysis and assumptions justified a stronger interpretation; the registry record does not report such details.

Masking is listed as none. In general, masking can reduce the opportunity for knowledge of an assigned intervention to influence some aspects of trial conduct or assessment. The registry does not explain whether masking was feasible for any measurement, or how lack of masking was addressed. No further inference about the effect of masking on this endpoint is warranted from the record.

How should uncertainty be assessed?

In general, a confidence interval describes a range of values compatible with the observed data under a specified statistical method. It conveys uncertainty around an estimate; it is not a guarantee that the true value lies within the interval. For a binary endpoint, an interval around a proportion or difference can show how much uncertainty remains, especially when the number of observed participants or events is limited. The registry record does not report a primary endpoint estimate or confidence interval, so the precision of the endpoint result cannot be evaluated.

Similarly, a p-value addresses compatibility between data and a specified null hypothesis under the assumptions of a statistical test. It does not measure the size or practical importance of an effect. No primary endpoint p-value or hypothesis-testing result is reported in the registry record. The record also does not identify the hypothesis, test, or any adjustment used for the six listed analyses.

What do the planning calculations represent?

The registry describes planning illustrations based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The assumed effect to detect is a stated fraction of the observed effect. In general, this type of calculation asks how many participants per arm might be needed under specified assumptions to achieve a chosen power for a future or hypothetical comparison. It is not a statement of the probability that the completed study produced a significant result, and it is not observed power.

The record characterizes these values as planning illustrations rather than the trial’s own design. It does not report the trial’s sample-size justification in the registry information, nor does it provide the numerical illustration results in the registry record for this analysis. The planning assumptions therefore should not be read as evidence that the trial was designed around a particular effect or as an explanation of its enrollment. The record does not report the protocol’s sample-size rationale.

More generally, statistical methods need to match the outcome type and design. Binary participant counts can be analyzed using methods for proportions or categorical outcomes, but the correct method depends on the planned estimand, group structure, and analysis assumptions. It would be inappropriate to infer a particular model from the fact that the outcome is binary or from the presence of six analyses. The registry record does not report which methods were used for the endpoint analyses, whether adjusted estimates were calculated, or how missing outcome data were handled.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists two outcome measures and six analyses. Multiple outcomes or analyses can create a multiplicity question: when several statistical tests are conducted, the chance of at least one apparently unusual result can increase, depending on the tests and how they are related. In general, investigators may address this by defining a hierarchy, adjusting significance thresholds, or treating some analyses as exploratory. The registry record does not report a multiplicity strategy, identify which analyses were confirmatory, or state how results were prioritized. No conclusion about adjustment should be inferred from the number of analyses alone.

The Full Analysis Set is defined as participants who completed the study and did not meet any protocol exclusion criteria. A participant could have only one product included in that set, and the registry states that the FAS was used for primary and secondary endpoints. This definition provides some information about who was intended for endpoint analysis, but it does not describe all analysis populations or establish how exclusions were applied in practice. The number of participants in the FAS is not reported in the registry record.

Missing data methods are also not reported in the registry record. It is not stated how incomplete measurements, missing endpoint classifications, or participants who did not complete the study were handled beyond the FAS definition. The record does not describe imputation, sensitivity analyses, or reasons for missingness. Without those details and the actual outcome counts, readers cannot assess whether missing observations could have affected the endpoint findings or how robust any estimate would be.

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 non-serious adverse event terms

The registry reports serious adverse event counts by recorded group. There were zero serious adverse events among the 99 participants at risk in the Single Platelet Product group, zero among the 101 at risk in the Double Platelet Product group, zero among the 100 at risk in the Triple Platelet Product group, and zero among the 35 at risk in the Unassigned group. Deaths were recorded as zero in each group. No serious adverse event terms are listed.

Other adverse events were recorded for 10 participants in the Single Platelet Product group, 8 in the Double Platelet Product group, 9 in the Triple Platelet Product group, and 10 in the Unassigned group. These are counts, not percentages, and no additional details about the types or severity of these other events are reported in the registry record.

Zero reported serious events means none were recorded in the listed groups; it does not establish that an event was impossible or that the intervention has no safety risks. The groups are nonrandomized and are not a like-for-like control comparison, so their event counts should not be interpreted as comparative treatment effects. The record does not report further detail on event collection or follow-up beyond the listed safety counts.

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

The trial’s stated purpose was to evaluate whether platelet products collected using the Trima Accel system with Version 7.0 software met specified residual WBC criteria. The registry supplies a clear endpoint definition and identifies the intended analysis population. It also records completion and enrollment. However, the primary endpoint results are not reported in the registry record, so the number or proportion of participants meeting the criteria cannot be described.

This distinction is important: a study objective is not a finding, and an endpoint threshold is not evidence that the threshold was achieved. The registry record does not report the endpoint counts, an estimate of performance, or uncertainty around an estimate. It also does not report the secondary acceptable platelet yield results. Accordingly, readers cannot use this record to establish the observed frequency of acceptable products or the precision of that frequency.

The design does not create a randomized comparison of product types or software versions. The listed categories are single, double, and triple platelet products, all associated with the Version 7.0 system. The registry identifies no separate comparison device or randomized control group. Therefore, the record does not support a causal claim that one product category, software version, or collection approach outperformed another.

The safety counts offer a limited descriptive account: no serious adverse events or deaths were recorded in the listed groups, while other adverse events were recorded. Those counts do not replace the missing primary outcome results and cannot establish comparative safety. The unassigned group is also listed for safety, but the registry does not explain its status in relation to the endpoint analysis.

Overall, the registry record explains what the study set out to measure and how acceptance was defined, but does not provide the main outcome data needed to judge the endpoint result. No conclusion about whether the stated leukoreduction criteria were met across the evaluated products can be drawn from the information reported.

13. Why This Trial Matters Statistically

This trial is statistically notable because it links a technical measurement to a threshold-based endpoint. The primary outcome is not merely the measured residual WBC value; it is the number of participants whose products satisfy criteria defined for the relevant product type. This illustrates how a clinical or technical objective can be translated into an analyzable binary endpoint. The interpretation still depends on having both the number who met the criterion and the number assessed, neither of which is reported for the primary outcome in the registry record.

The three collection categories also illustrate why endpoint definitions need to be read alongside study design. Single, double, and triple products use different stated limits, and the trial is nonrandomized. Product categories are not interchangeable comparison arms simply because they appear in parallel groups. A valid statistical comparison would need to consider the different acceptance rules and the nonrandomized group structure. The registry explicitly cautions that the arms are not a like-for-like control comparison.

Another statistical lesson is the difference between planning assumptions and observed findings. The registry describes planning illustrations using an observed effect and specified assumptions, but such illustrations do not establish the trial’s design rationale or its observed precision. They are not observed power. Separately, the record lists six analyses, which makes reporting of the analysis plan and multiplicity approach relevant; those details are not reported.

Finally, completeness of registry reporting is itself important for interpretation. Without outcome counts, estimates, or uncertainty measures, the main performance question remains unanswered by the record, even though the endpoint and study population are described. This highlights why results reporting needs to include analyzable denominators, outcome numerators, and methods for handling missing observations, in addition to design and safety information.

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 direct limitation for interpreting this evaluation is that the registry record does not report primary endpoint results. It gives product-specific residual WBC criteria and a timeframe, but no count of participants meeting the criteria, no count assessed, and no estimate of uncertainty. The secondary acceptable platelet yield outcome is named, but its results are not reported either.

The design is nonrandomized, with no masking, and the registry explicitly states that the arms are not a like-for-like control comparison. The product categories differ by collection type and use different endpoint thresholds. The record does not report detailed assignment procedures or an analysis that would support causal comparisons among these categories.

The Full Analysis Set is described, but its size and the number excluded from it are not reported. The record does not describe handling of missing endpoint data, other analysis populations, or sensitivity analyses. It also does not report a detailed statistical analysis plan, the methods used for the six listed analyses, or any multiplicity procedure.

The planning illustrations are described as such, but the registry information does not report the trial’s sample-size justification. The safety counts are descriptive and lack detail on the other adverse events, including their types. These limitations restrict assessment of outcome magnitude, precision, robustness, and comparative interpretation from the registry record.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Evaluation of Trima Version 7.0 Platelets in PAS — NCT02754440.
• Registry record last updated 2018-05-11; status last verified 2018-04.
• Results first posted 2018-05-11.
• 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 completed study evaluated platelet collection using the Trima Accel system with Version 7.0 software in healthy adult volunteer blood donors. It was nonrandomized, unmasked, and parallel, with an enrollment of 365. The registry describes single, double, and triple platelet products, with concurrent plasma collected in 25% of collections in each category.

The primary endpoint counted participants with products meeting product-specific residual WBC criteria within 48 hours of donation. The Full Analysis Set included participants who completed the study and met the stated exclusion criteria, with one product per participant. The registry record does not report primary or secondary endpoint results.

Safety records list zero serious adverse events and zero deaths in each product and unassigned group. Other adverse events are recorded, but their types are not reported. Detailed methods for missing data, multiplicity, and the six listed analyses are not reported in the registry record.