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 Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T) (NCT04976530), a randomized na study. The primary outcome is Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Modified Intent to Treat (mITT) Population.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04976530 |
| Phase | NA |
| Condition | Hemorrhage, Surgical, Blood Loss, Surgical, Blood Loss, Postoperative |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 140 |
| Arms in the primary outcome | 2 |
| Lead sponsor | CytoSorbents, Inc |
| Results posted | Yes |
2. Clinical Question
Population
Patients undergoing urgent cardiothoracic surgery with cardiopulmonary bypass after stopping ticagrelor <2 days before surgery. The primary analysis population is described as modified intent-to-treat (mITT). The record does not give further eligibility details or a definition of mITT, so the exact boundaries of the population represented by that label are not reported in the registry record.
Intervention
Standard of care plus the DrugSorb-ATR system, used intraoperatively for removal of ticagrelor. The trial evaluated the system in the context of cardiac surgery with cardiopulmonary bypass; the record does not provide procedural details beyond this description.
Comparator
Standard of care with a sham set-up. The trial is described as randomized, double-blind in its official title, and quadruple-masked in the design fields. Further details about which roles were masked or how masking was maintained are not reported in the registry record.
Primary question
Did the DrugSorb-ATR group have better ranked perioperative bleeding outcomes than the sham group through the first 48hrs post-operation? The composite ranks fatal perioperative bleeding first, moderate, severe, or massive bleeding events based on UDPB >2 classification second, and 24 hour chest tube drainage third. The comparison uses an unmatched win ratio rather than a simple difference in the number of participants with an event.
3. Trial Design
STAR-T is described as a prospective, multi-center, randomized, parallel-group trial. Its official title describes a double-blind study, while the design field specifies quadruple masking. The registry identifies the two groups as Control and DrugSorb-ATR Intervention. Control received standard of care with a sham set-up; the intervention group received standard of care plus DrugSorb-ATR. The record does not describe the randomization sequence, allocation concealment, or masking procedures in detail.
The trial concerned urgent cardiothoracic surgery with cardiopulmonary bypass among patients who had stopped ticagrelor <2 days before surgery. The listed enrollment is 140. The primary endpoint results are reported for the mITT population, with 66 participants in each displayed primary analysis group. The registry does not explain the relationship between listed enrollment and the population included in this primary analysis, nor does it provide a flow of participants through screening, randomization, treatment, and analysis.
The record lists the study as completed and gives its start and primary completion dates as 2021-08-31 and 2023-08-07. It identifies CytoSorbents, Inc as sponsor. The phase is listed as NA. The trial is described as pivotal, but the rationale for the planned enrollment, the statistical design assumptions, and any protocol-defined decision criteria are not reported in the registry record.
Secondary outcomes include chest tube drainage and transfusions of packed red blood cells and platelets. Some entries refer to mITT and others to an i-CABG per-protocol population. The record does not explain these population definitions or provide enough detail to establish how each secondary analysis relates to the primary analysis population.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Control | DrugSorb-ATR Intervention |
|---|---|---|
| STARTED | 70 | 70 |
| COMPLETED | 70 | 70 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: mITT, modified intent-to-treat
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: Analysis population = modified intent to treat (mITT), ie, randomized subjects who had surgery and received a study device (control or intervention).
| Characteristic | Unit | Control | DrugSorb-ATR Intervention | Total |
|---|---|---|---|---|
| Participants analysed | 66 | 66 | 132 | |
| Age, Continuous | years | 64.5 (SD 8.54) | 64.4 (SD 10.63) | 64.5 (SD 9.6) |
| Sex: Female, Male: Female | Participants | 10 | 10 | 20 |
| Sex: Female, Male: Male | Participants | 56 | 56 | 112 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 5 | 3 | 8 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 6 | 4 | 10 |
| Race (NIH/OMB): White | Participants | 50 | 53 | 103 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 5 | 6 | 11 |
| Region of Enrollment: Canada | participants | 22 | 23 | 45 |
| Region of Enrollment: United States | participants | 44 | 43 | 87 |
| Hypertension | Participants | 58 | 54 | 112 |
| Heart failure | Participants | 23 | 18 | 41 |
| Coronary artery disease | Participants | 62 | 61 | 123 |
| Thrombocytopenia | Participants | 6 | 5 | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Incidence of Perioperative (Periop) Bleeding, Primary Effectiveness Composite Endpoint, Modified Intent to Treat (mITT) Population, measured over Through the first 48hrs post-operation.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | number of wins |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is a ranked composite of perioperative bleeding outcomes assessed through the first 48hrs post-operation. The components are ordered by clinical severity: fatal perioperative bleeding; moderate, severe, or massive bleeding events using the universal definition for perioperative bleeding (UDPB) >2 classification; and 24 hour chest tube drainage volume. The endpoint is reported as numbers of wins and analyzed using an unmatched win ratio.
For each comparison, a participant in the Sham arm is paired with a participant in the DrugSorb-ATR arm. The composite hierarchy determines the comparison: a pair is judged using the highest-ranked component that distinguishes the participants. A win is assigned to the participant with the better outcome, such as less bleeding. The registry describes the win ratio as the total number of winners in DrugSorb-ATR divided by the total number of winners in Sham.
In general, hierarchical composites allow outcomes of differing severity to contribute in an ordered way, rather than treating every component as equivalent. This can preserve the priority given to more serious events while still incorporating a measure such as drainage volume. The trade-off is that the summary depends on the specified ordering and on how ties and unavailable component data are handled. Those implementation details are not reported in the registry record. The primary endpoint is therefore a comparative ranking measure, not a direct estimate of the number of people who experienced bleeding or a difference in average drainage.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports a win ratio of 1.07 for DrugSorb-ATR relative to Sham, with a 95% confidence interval (CI) of 0.72 to 1.58 and p=0.748. The posted numbers of wins are 2244 for DrugSorb-ATR and 2103 for Control. As described in the registry, a win ratio greater than 1.0 favors the treatment arm. The point estimate is slightly on that side of the reference value, but the interval includes values on either side of 1.0.
In general, a confidence interval expresses uncertainty around an estimated effect under the assumptions of the analysis. The 95% CI gives a range of values compatible with the data and method at the stated confidence level; it is not a guarantee that the true effect lies in that particular interval. In this case, the interval ranges from 0.72 to 1.58, so it includes the value 1.0, which represents equal totals of wins under the win-ratio interpretation. The estimate is not precise enough to exclude effects in either direction within the interval.
The reported p-value is 0.748. In general, a p-value describes how unusual data at least as incompatible with a specified null hypothesis would be if that hypothesis and the analysis assumptions held. It is not the probability that the null hypothesis is true, nor is it a measure of clinical importance. The registry record does not state the trial's prespecified significance threshold or give a full statistical analysis plan, so the p-value should be read as the reported result rather than as a complete account of the decision rule.
The numbers of wins are not counts of individual participants who did or did not bleed. The endpoint is formed from repeated pairwise comparisons between participants in the two arms, and one participant may contribute to comparisons with multiple participants in the other arm. The 2244 and 2103 figures therefore describe the endpoint's win totals, not the number of people with favorable outcomes. The ratio and its uncertainty are the more direct summaries for interpreting the stated method.
The result does not establish that the groups were identical. The confidence interval spans values below and above 1.0, and the p-value alone cannot establish equivalence. No equivalence or non-inferiority margin is reported. The registry result is best described as an estimated win ratio of 1.07 with substantial uncertainty, rather than as proof of a difference or proof of no difference. It also does not by itself indicate which component of the composite contributed most to the overall comparison.
9. Statistical Methods Explained
The primary analysis uses an unmatched win ratio, with the method named in the registry as the Finkelstein Schoenfeld test. This approach compares outcomes across two groups by considering pairs consisting of one participant from each group. It is called unmatched because participants are not described as being paired with a particular counterpart before the outcome comparison. Instead, each participant in one arm is compared with each participant in the other arm.
How does the ranked comparison work?
In general, a hierarchical comparison assesses outcomes in a prespecified order. For this trial, fatal perioperative bleeding has the highest rank, followed by moderate, severe, or massive bleeding under UDPB >2, and then 24 hour chest tube drainage. If the first component distinguishes a pair, the comparison can be decided at that level; if not, the next component can be considered. The record says a win is awarded for the better outcome, such as less bleeding. It does not state all operational rules for ties, missing components, or the handling of every possible combination of outcomes.
This hierarchy gives greater priority to the more serious components than to drainage volume. In general, that can make a composite result easier to interpret as an ordered comparison than a simple sum of components with different meanings. However, the overall win ratio can be influenced by how often each level of the hierarchy distinguishes pairs. A summary estimate alone does not reveal how many comparisons were decided by fatal bleeding, other bleeding events, or drainage. Component-specific results sufficient to separate those contributions are not reported in the primary result described in the record.
What does the win ratio express?
The registry defines the ratio as total winners in DrugSorb-ATR divided by total winners in Sham. A value of 1.07 means the reported total of wins in the intervention arm is modestly higher relative to the control-arm wins, while the record specifies that a ratio above 1.0 favors treatment. The ratio is not a risk ratio, an odds ratio, or a ratio of event rates. It should not be read as the percentage of participants who benefited, because the unit of comparison is a pairwise win and participants can contribute to multiple pairs.
The reported win totals are 2244 in DrugSorb-ATR and 2103 in Control. The primary analysis groups each contain 66 participants. The comparison is described as unmatched, and the registry explains that each participant in Sham is compared with each participant in DrugSorb-ATR. These totals are therefore outputs of the pairwise method rather than participant counts. They cannot be interpreted as the number of events or as independent observations in the same way as a simple two-group count.
How should the interval and p-value be read?
The 95% CI is 0.72 to 1.58. In general, a confidence interval conveys sampling uncertainty around an estimate, conditional on the statistical model and study procedures. The reference value for a win ratio is 1.0, indicating equal totals of wins between the two arms. Since the reported interval includes 1.0 and values both below and above it, the result is compatible with a range of comparative patterns. The breadth of the interval signals that the estimate does not tightly locate the win ratio.
The reported p-value is 0.748. In general, a p-value is calculated under a null hypothesis and describes the compatibility of the observed data with that hypothesis under the model. It does not quantify the probability that the intervention is effective, and it does not measure the size or importance of an effect. The registry names the Finkelstein Schoenfeld test but does not report a detailed formula, variance procedure, or all implementation choices. A fuller account of those choices is not reported in the registry record.
What information is needed to reproduce the analysis?
Reproducing a ranked win-ratio analysis requires more than the group-level win totals. The analysis would need participant-level outcomes for the hierarchical components, rules for tied or unavailable values, the exact analysis population, and the method used to calculate uncertainty and the p-value. The registry provides the endpoint description, group sizes, win totals, ratio, confidence interval, p-value, and test name. Participant-level data and additional implementation details are not reported in the registry record.
In general, a statistical method can be appropriate for the endpoint while still leaving uncertainty about its implementation when reporting is brief. The record's description clarifies the direction of the comparison and the order of endpoint components, but does not permit independent reconstruction from the posted summary statistics alone. The reported estimate should therefore be interpreted as the registry's stated result using the named method, not as a separately reproduced analysis.
10. Analyses Reported by the Sponsor
| Method | Estimate | 95% CI | P-value |
|---|---|---|---|
| Finkelstein Schoenfeld test | win ratio 1.07 | 0.72 to 1.58 | 0.748 |
The registry reports the primary result as a Finkelstein Schoenfeld test with a win ratio of 1.07, a 95% CI of 0.72 to 1.58, and p=0.748. These are the reported analysis results for the endpoint. The record does not identify a separate recalculated win ratio or provide enough participant-level information to reproduce the ranked comparisons independently from the summary figures.
No discrepancy between a reported analysis and a recalculated estimate is indicated in the registry record. Since a separate recalculated estimate is not reported, there is no alternative summary to set alongside the registry analysis. The reported analysis should be treated as the primary statistical result available in the record; no independent recalculation is presented to confirm or challenge it.
In general, a recalculation from summary statistics can check only what those summaries permit and may not reproduce an analysis that depends on participant-level rankings or specialized variance methods. For this endpoint, the pairing structure and hierarchy are central to the estimate. The win totals alone do not encode enough detail to reconstruct how every pair was judged. Details of any sponsor-side analyses beyond the posted result are not reported in the registry record.
11. Multiplicity, Missing Data and Analysis Populations
The primary endpoint is a single ranked composite, but the registry also lists secondary outcomes, including chest tube drainage and packed red blood cell and platelet transfusions. Some outcome entries are repeated for mITT and i-CABG per-protocol populations. The record lists 8 secondary outcome entries; it does not explain whether the repeated entries represent separate planned analyses, duplicate registry entries, or another distinction.
When a study evaluates multiple outcomes or populations, the chance of at least one apparently notable result can increase if each result is assessed separately without accounting for the number of comparisons. In general, multiplicity methods can control or describe that issue, but the choice depends on the prespecified testing strategy and purpose of each outcome. Whether the trial used a hierarchy for testing, adjusted p-values, or another multiplicity approach is not reported in the registry record. No inferential secondary-outcome results are detailed in the primary result information, so no conclusion about those outcomes can be drawn from the primary win ratio.
The primary population is labeled mITT, and secondary outcomes refer to mITT and i-CABG PP populations. The definitions of these analysis populations, exclusions after randomization, and handling of participants who did not receive the assigned set-up are not reported in the registry record. A clear population definition matters because changing which participants are analyzed can change the target comparison and the estimate.
The registry describes the primary endpoint timeframe, but the approach to missing outcome components is not stated. It does not report whether missing values were imputed, treated as unavailable, or handled by another rule. Values for a two-arm comparison are also identified as missing or not estimable for a count-other endpoint; this does not establish that the primary win-ratio result is missing, but it limits interpretation of other count-type results. The protocol's missing-data plan, if any, is not reported in the registry record.
The sample-size justification, planned interim analyses, prespecified testing thresholds, and complete analysis plan are not reported in the registry record. Without those details, the posted p-value and endpoint estimate can be described, but the full confirmatory testing strategy cannot be assessed.
12. 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 |
|---|---|---|---|
| Control | 19 | 66 | 28.8% |
| DrugSorb-ATR Intervention | 25 | 66 | 37.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Control | 1 of 66 |
| DrugSorb-ATR Intervention | 1 of 66 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Control | 57 of 66 |
| DrugSorb-ATR Intervention | 58 of 66 |
Most frequent serious adverse event terms
| Event term | Organ system | Control | DrugSorb-ATR Intervention |
|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | 2 of 66 | 3 of 66 |
| Atrial fibrillation | Cardiac disorders | 4 of 66 | 0 of 66 |
| Haemothorax | Respiratory, thoracic and mediastinal disorders | 0 of 66 | 4 of 66 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 2 of 66 | 2 of 66 |
| Hypotension | Vascular disorders | 1 of 66 | 3 of 66 |
| Acute kidney injury | Renal and urinary disorders | 1 of 66 | 3 of 66 |
| Cardiac tamponade | Cardiac disorders | 3 of 66 | 0 of 66 |
| Cardiogenic shock | Cardiac disorders | 2 of 66 | 1 of 66 |
| Cerebral vascular event | Nervous system disorders | 0 of 66 | 3 of 66 |
| Coagulopathy | Blood and lymphatic system disorders | 0 of 66 | 2 of 66 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Control | DrugSorb-ATR Intervention |
|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | 22 of 66 | 28 of 66 |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | 13 of 66 | 16 of 66 |
| Anaemia | Blood and lymphatic system disorders | 11 of 66 | 11 of 66 |
| Investigations | Vascular disorders | 10 of 66 | 12 of 66 |
| General disorders and administration site conditions | Renal and urinary disorders | 8 of 66 | 10 of 66 |
| Atelectasis | Respiratory, thoracic and mediastinal disorders | 8 of 66 | 8 of 66 |
| Gastrointestinal disorders | Gastrointestinal disorders | 7 of 66 | 9 of 66 |
| Blood loss anaemia | Blood and lymphatic system disorders | 8 of 66 | 7 of 66 |
| Hypotension | Vascular disorders | 6 of 66 | 9 of 66 |
| Acute kidney injury | Renal and urinary disorders | 3 of 66 | 12 of 66 |
Serious events with the highest arm-level rate: atrial fibrillation (6.1%), haemothorax (6.1%), cardiac tamponade (4.5%), anaemia (4.5%), hypotension (4.5%).
The adverse-event information gives serious adverse events for 19 participants in Control and 25 in DrugSorb-ATR Intervention, with 66 participants at risk in each group. Other adverse events are reported for 57 in Control and 58 in DrugSorb-ATR Intervention. Deaths are reported as 1 in each group. These are counts in the registry record; no confidence intervals or formal between-group safety comparisons are reported alongside them.
The listed serious adverse event terms and percentages are atrial fibrillation, 6.1%; haemothorax, 6.1%; cardiac tamponade, 4.5%; anaemia, 4.5%; hypotension, 4.5%; and cerebral vascular event, 4.5%. The record does not assign these listed percentages to a specific arm in the information, so they should not be interpreted as arm-specific rates.
In general, adverse-event counts describe events recorded under a study's definitions and monitoring procedures. They do not by themselves establish that an event was caused by a treatment, and counts alone do not account for uncertainty or differences in event severity and timing. The registry does not provide additional information in this result about event-level recurrence, exposure time, causality assessment, or the criteria used to classify events as serious. These figures are descriptive and should be read separately from the primary bleeding endpoint.
13. What the Result Does, and Does Not, Mean
The primary result is an estimate of comparative performance on a specific ranked bleeding composite in the trial's mITT population. The win ratio of 1.07 favors DrugSorb-ATR according to the registry's stated direction, but its 95% CI of 0.72 to 1.58 includes 1.0. The p-value is 0.748. Together, these figures describe an estimate with uncertainty, not a definitive demonstration that one group had better outcomes or that the groups were equivalent.
The endpoint combines fatal perioperative bleeding, bleeding events classified as moderate, severe, or massive under UDPB >2, and 24 hour chest tube drainage, in that order. Its result does not indicate which component drove the comparison. Nor does it directly state how many participants experienced any bleeding, because the reported win totals arise from pairwise comparisons between participants in the two groups.
In general, a failure to distinguish groups statistically is not the same as evidence of equivalence. Equivalence requires a prespecified margin and an analysis designed to assess whether the uncertainty is sufficiently narrow to rule out differences considered important. No equivalence margin is reported in the registry record. Similarly, the reported result alone does not establish whether a particular effect size is clinically important; that depends on clinical context and criteria not described in the result.
The registry record also includes adverse-event counts and secondary outcome labels. Those details do not replace the primary endpoint analysis and do not provide a complete safety or effectiveness profile. The record does not report full results for all secondary outcomes in the information summarized, nor does it describe the handling of missing component data in the primary analysis.
The most direct reading is therefore limited: in this randomized trial, the posted primary analysis yielded a win ratio of 1.07, with a 95% CI from 0.72 to 1.58 and p=0.748. The result leaves uncertainty about the direction and magnitude of the comparative effect on the defined composite. It should not be extended to outcomes, populations, or settings not represented by the registry's reported analysis.
14. Why This Trial Matters Statistically
This trial illustrates how a clinical endpoint can be more complex than a single event count. Perioperative bleeding has outcomes with different levels of severity, and the primary composite ranks those outcomes rather than assigning them equal weight. The interpretation depends on the stated hierarchy: fatal bleeding is considered before other classified bleeding events, and those are considered before chest tube drainage.
It also shows why an effect measure must be read according to its unit. The win ratio is based on comparisons between participants in separate arms, not on a ratio of individual event risks. The reported totals of wins are not numbers of people who benefited or had an adverse outcome. A reader who treats them as ordinary participant counts could draw an incorrect interpretation of the result.
Uncertainty is central to the reported finding. The point estimate is 1.07, but the 95% CI extends from 0.72 to 1.58 and includes 1.0. The p-value is 0.748. Reporting the estimate together with its interval conveys more than describing the point estimate alone: it shows that the result does not tightly determine the direction or magnitude of the win-ratio effect.
Finally, the registry record highlights the importance of reporting analysis populations, missing-data rules, and multiplicity plans. The primary population is labeled mITT, while secondary outcomes refer to both mITT and i-CABG per-protocol populations. The record does not give those population definitions or a full analysis plan. Such details help readers understand exactly which comparison an estimate represents and how it fits into the broader set of trial outcomes.
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 registry provides a concise description of the primary composite and its win-ratio method, but not all details needed to reconstruct the analysis. The rules for ties, unavailable components, and the calculation of uncertainty are not reported in the registry record. Those details matter because they can affect pairwise classifications and the resulting estimate.
The primary analysis is described as mITT, but the record does not define that population or show participant flow into the analysis. The listed enrollment is 140, while the primary result reports 66 participants in each group; the record does not explain the relationship between these figures. It also does not report whether participants were excluded after randomization or how deviations from assigned treatment were handled.
The reported primary result does not separate the contributions of fatal bleeding, classified bleeding events, and chest tube drainage. The registry also lists secondary outcomes across mITT and i-CABG per-protocol populations, but definitions and complete results for these entries are not reported in the information available. The effect of any multiplicity adjustment cannot be assessed because the testing strategy is not reported.
Other information needed for a fuller assessment—including the sample-size justification, interim-analysis plan, missing-data methods, protocol-defined thresholds, and detailed masking and allocation procedures—is not reported in the registry record. The posted summary therefore supports interpretation of the stated estimate and its uncertainty, but it does not provide a complete account of all design and analysis decisions.
16. Related Tutorials
17. Related Statistical Calculators
18. Sources
- ClinicalTrials.gov: Safe and Timely Antithrombotic Removal - Ticagrelor (STAR-T) — NCT04976530.
- Registry record last updated 2026-10-26; status last verified 2026-10.
- Results first posted 2025-04-11.
- 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.
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19. Record Summary
STAR-T is a completed, prospective, multi-center, randomized, parallel-group trial with quadruple masking in the design record. It evaluated the DrugSorb-ATR system during urgent cardiothoracic surgery with cardiopulmonary bypass among patients who stopped ticagrelor <2 days before surgery. The control group received standard of care with a sham set-up, and the intervention group received standard of care plus DrugSorb-ATR.
The primary endpoint was a ranked perioperative bleeding composite through the first 48hrs post-operation, analyzed by an unmatched win-ratio method in the mITT population. The reported win ratio was 1.07, with a 95% CI of 0.72 to 1.58 and p=0.748. The interval includes 1.0, so the posted estimate remains uncertain in direction and magnitude. Further details about analysis populations, missing-data handling, multiplicity, and the full statistical plan are not reported in the registry record.