Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters (NCT02796300), a randomized na study. The primary outcome is Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters..

2. Clinical Question

The study was a prospective randomized comparison with a parallel-group design and no masking. Its broader stated aim was to compare complications and general outcomes, with catheter thrombosis as a central concern. The registry summary says participants would be observed for three to six months, while the posted primary outcome is specified at 1 month. These descriptions identify the study’s intended scope and the registered endpoint, but they do not establish that every participant had the same duration of observation.

The central statistical contrast is the mean outcome in the Palindrome group compared with the mean in the Bioflo group. The posted estimate is positive, so the recorded average tPA use was higher in the Palindrome group. That contrast describes the posted data; it does not by itself establish why the groups differed or how well the result would generalize to other patients, settings, or catheter-use practices.

3. Trial Design

This was a prospective, randomized, parallel-group device trial sponsored by the University of California, Los Angeles. Participants were assigned to one of two groups: hemodialysis using a Bioflo catheter or hemodialysis using a Palindrome catheter. The registry lists no masking. The study is marked terminated, but the reason for termination is not reported in the registry record.

The registry lists an enrollment of 32. The primary outcome results include 10 participants in the Bioflo group and 22 in the Palindrome group. Those counts add to the recorded enrollment, but the registry record does not describe the sequence generation, allocation concealment, intended allocation ratio, or participant flow. It also does not say whether all enrolled participants were included in every outcome analysis.

The primary outcome was a mean measure of tPA use as an indicator of thrombosed catheter, expressed per month, with a timeframe of 1 month. The registry also lists secondary outcomes for catheter thrombosis at 3 months and cost analysis at 3 months. The summary describes planned observation for three to six months. The record does not explain how the stated observation period relates to each participant’s actual follow-up or whether follow-up was shortened by the termination.

The record does not report the original sample-size justification, the planned analysis population, a detailed statistical analysis plan, or any interim-analysis plan. It reports no separate analyses in the results listings. The posted means, standard errors, group counts, and comparisons still allow a descriptive reading of the outcome summaries, but they do not reveal all the methods used by the investigators.

The distinction between the randomized design and the posted results matters. Random assignment can support a comparison between groups when carried out and analyzed as planned, but the registry record does not contain enough detail to assess all parts of that process. The imbalance in posted group counts is visible in the outcome results; the reason for it is not reported in the registry record. The results should therefore be read as the comparison posted for this terminated study, with the design information and reporting gaps kept in view.

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: No significant events occurred in this study prior to assignment to a group

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters., measured over 1 month.

The primary endpoint is the mean number of tPA uses per month, described as an indicator of catheter thrombosis. The registry gives a timeframe of 1 month and labels the outcome as catheter thrombosis rate. In practical terms, the reported measure is not a direct event count in the posted description: it is the number of tPA uses, used as a signal of thrombosed catheter.

An indicator can be useful when the underlying event is difficult to measure consistently or when a related treatment or action is recorded in routine care. Here, the proposed rationale is that tPA use reflects catheter thrombosis. However, the registry record does not report criteria for deciding when to use tPA, whether the measure was independently adjudicated, or how use for reasons other than thrombosis was handled. Those details affect how directly the endpoint represents thrombosis itself.

The outcome is summarized as a group mean with a standard error. A mean describes the average recorded use in each group; it does not show the distribution of individual participants or the number of participants who experienced any thrombosis. Thus, the endpoint supports a comparison of average tPA use as defined in the record, not a complete account of each participant’s catheter events or complications.

The endpoint is relevant to the study’s stated concern about catheter thrombosis and its associated consequences. Still, interpretation should stay close to the recorded measure. The posted comparison concerns tPA use as an indicator of thrombosis, and should not be treated as a direct measure of every thrombosis event or of broader catheter safety.

7. Results Posted in the Registry

• Palindrome Group: mean 7.27 versus 4.30 on control; difference 2.97 (95% CI 1.51 to 4.43), standardized effect d = 1.38; z-test p = <0.001.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • Palindrome Group: mean 12.40 versus 8.60 on control; difference 3.80 (95% CI 1.17 to 6.43), standardized effect d = 0.90; z-test p = 0.005.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically higher for Palindrome Group than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Cost Analysis

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • Palindrome Group: mean 78,909 versus 60,200 on control; difference 18,709 (95% CI -1,638 to 39,056), standardized effect d = 0.56; z-test p = 0.072.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Palindrome Group and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes extend the primary question in two ways: the registry lists a later timeframe for the thrombosis-indicator measure and also reports a cost comparison. Across the posted thrombosis-indicator timeframes, the direction of the group means is consistent with the primary comparison. The cost means point in the same direction as well, but the evidence for that comparison is less decisive. The tables present the endpoint-specific estimates and uncertainty, so this overview focuses on their overall relationship rather than repeating those values.

Directional consistency across timeframes can be informative because it suggests that the primary pattern is not isolated to a single listed measurement period. However, the comparisons are not independent replications: they come from the same trial and overlapping study groups, and the registry record does not report participant-level relationships between measurements. Similar directions therefore do not provide the same confirmation as a separate trial.

The cost outcome addresses a different question from catheter thrombosis. Its results cannot validate the thrombosis measure, and the thrombosis comparisons do not establish a cost consequence. Cost estimates can also depend on what resources and time periods were included, but the registry record does not describe the components of the cost calculation. Interpretation should remain limited to the posted mean cost outcome and its reported uncertainty.

Unadjusted secondary results carry less weight than a prespecified primary outcome because multiple outcomes and timeframes create more opportunities for chance findings. The registry record does not report a plan for controlling the family of comparisons or identify a hierarchy among the secondary outcomes. It also lists no separate reported analyses. The direction of the secondary findings can provide context, but it should not be treated as conclusive confirmation or as a replacement for the primary result.

Overall, the secondary pattern is broadly aligned with the primary direction for the thrombosis indicator, while the cost comparison is more uncertain. This pattern adds descriptive context, but it does not resolve limitations in sample size, endpoint measurement, follow-up, or analysis reporting. Readers should use the endpoint-specific tables for the numerical detail and interpret the secondary outcomes as exploratory unless a fuller prespecified analysis plan is available.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
• Catheter Thrombosis Rate of Bioflo Catheters vs. Palindrome Catheters.
• Cost Analysis

9. Statistical Interpretation

10. Statistical Methods Explained

The results are presented as means for continuous outcomes. A mean is the arithmetic average of the recorded values in a group. For the primary endpoint, the posted group means describe average tPA use per month, which the registry uses as an indicator of catheter thrombosis. A mean does not reveal whether the values were similar across participants or concentrated among a smaller number of participants. The registry record does not provide participant-level data or a distribution plot in the information.

What does the mean difference represent?

The primary comparison is reported as a mean difference. Its direction is Palindrome minus Bioflo: a positive estimate means the Palindrome group’s posted mean is larger. The reported difference is 2.97. This is a contrast between group averages, not a count of additional events for each participant and not a percentage change. It also does not mean every participant in one group had more tPA use than every participant in the other group.

The comparison is unadjusted in the sense that the reported result is not described as controlling for other measured factors. The registry record does not report covariate adjustment or a detailed model specification. As a general statistical point, adjustment can account for selected measured characteristics, but it does not automatically remove bias from unmeasured differences or correct problems in how an endpoint was recorded.

What does the standard error describe?

The group summaries use standard errors. A standard error describes the uncertainty of an estimated mean, rather than the spread of individual observations. It is therefore different from a standard deviation, which describes variation among individual values. The posted standard errors are 0.56 for Bioflo and 0.49 for Palindrome. These values help characterize precision of the mean estimates, but they do not show the full range of participant outcomes.

The registry also reports a pooled standard deviation for the comparison. As a general concept, a pooled standard deviation combines estimates of within-group variation and can be used to express a mean difference in relation to variability. It is not another estimate of the treatment difference. The registry record does not report enough detail to establish every calculation choice behind the posted comparison, so the displayed statistic should be read as a reported summary rather than a reconstruction of the full analysis.

How should the confidence interval be read?

A confidence interval gives a range of estimates compatible with the observed data under the statistical procedure used. The primary interval runs from 1.512 to 4.428 for the Palindrome-minus-Bioflo mean difference. It describes uncertainty around the estimated group contrast. It is not a range containing a stated proportion of individual participants’ outcomes, and it does not account for every source of uncertainty, such as endpoint misclassification or incomplete follow-up.

The interval is entirely above zero. For a mean-difference contrast, zero represents equal group means. The posted interval therefore supports a difference in average recorded tPA use under the procedure used to calculate it. A confidence interval does not assign a probability to a particular fixed value being true, and it should not be interpreted as proof of causation or clinical importance.

What does the p-value add?

The primary unadjusted p-value is <0.001. A p-value describes how unusual data at least as incompatible with a specified null hypothesis would be if that null hypothesis and the statistical assumptions held. It is not the probability that the null hypothesis is true, nor does it measure the size or practical importance of the difference. Here, the reported p-value is consistent with the confidence interval’s indication that the average tPA use differed between the groups.

The value is labelled unadjusted. In general, when several outcomes or comparisons are examined, the chance of obtaining at least one apparently notable result can increase. The registry record does not report a multiplicity procedure. The primary endpoint remains the designated main outcome, but the unadjusted label is relevant when considering the collection of results as a whole.

What can be inferred from the design?

Randomization is intended to make assigned groups comparable on average, including with respect to factors that are not known in advance. The registry identifies the study as randomized, but does not report how the random sequence was generated, how assignment was concealed, or whether the analysis followed assignment as randomized. No masking is listed. These omissions mean the record does not allow a full appraisal of the protections against selection or measurement bias.

The posted group counts differ, and the record does not explain why. Unequal counts do not automatically invalidate a comparison, but they affect precision and can prompt questions about recruitment, exclusions, or missing outcomes. The registry record does not report a participant-flow account or explain whether all randomized participants contributed to each analysis.

In summary, the reported statistical quantities describe a comparison of group means, its estimated uncertainty, and a test against equal means. General explanations of these quantities do not imply that every conventional assumption was checked in this trial. The registry record does not report a detailed analysis plan, diagnostics, or sensitivity analyses. The numerical result can be described as posted, while its analytical basis and robustness remain incompletely documented.

11. Confidence Intervals and Precision

The primary mean difference is 2.97, with a 95% confidence interval from 1.512 to 4.428. The interval does not include zero, and both its lower and upper limits are positive. For the reported Palindrome-minus-Bioflo contrast, that means the estimated average tPA use is higher in the Palindrome group across the interval’s range of values under the procedure used. The interval gives a more informative sense of estimate precision than the p-value alone.

The interval is not especially narrow relative to the estimate: it spans a range of plausible mean differences rather than identifying one exact value. This uncertainty matters even when the interval excludes zero. The estimate’s direction is clear in the posted comparison, but the exact size of the difference remains uncertain. Precision is also distinct from validity; a narrow interval would not resolve uncertainty about endpoint definition, missing data, or study conduct.

The group standard errors are 0.56 and 0.49. They describe uncertainty around the estimated group means, not the variability of individual tPA use. The registry reports no confidence limits for the individual group means, but does report the interval for the comparison. The trial’s enrollment and group sizes are modest, so the estimate should not be assumed to provide the same precision as a larger, independently conducted study.

The secondary cost comparison has a confidence interval that crosses zero, so its estimate is compatible with either direction of the group difference under the reported interval procedure. The later thrombosis-indicator comparison has an interval above zero. These intervals, along with the primary interval, should be considered in light of multiple outcomes and the absence of a reported multiplicity adjustment. Confidence intervals quantify sampling uncertainty under a statistical procedure; they do not capture all uncertainties arising from how the study was conducted or reported.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size section is a planning illustration based on the observed effects, not a description of the trial’s original design calculation. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each row uses the stated fraction of the observed effect as the effect to detect. The original sample-size assumptions for this trial are not reported in the registry record.

For these continuous outcomes, the values in the planning tables are participants per arm, not total participants and not total events. The table and curve show how the illustrative number changes with the chosen effect size and power target. The row describing 100% of the observed effect uses the full observed contrast as the planning target; the rows for 75% and 50% use smaller target effects. Smaller effects are harder to distinguish from random variation, so they require more participants under the same planning assumptions.

The 80% power column shows the planned participants per arm for a design that would have an 80% chance of detecting the specified effect at the stated significance level, if the planning assumptions and model were correct. The 90% power column gives the corresponding planning target for a higher chance of detection, which generally calls for more participants. Power is a design concept: it refers to the performance of a proposed study under specified assumptions, not certainty that a result will be statistically significant.

These figures are not observed power for this completed trial. They do not explain why the actual enrollment was 32, and they should not be read as evidence that the trial was adequately or inadequately planned. Because the illustration uses the observed effects, it is data-dependent and may reflect an effect estimate that is uncertain. The original design rationale and any assumptions used by the investigators are not reported in the registry record.

The curve is another way to view the planning relationship: as the target effect becomes smaller or the desired power becomes greater, the required participants per arm increase. It is a planning aid under the stated assumptions, not a forecast of future results or a substitute for a prespecified sample-size calculation based on a clinically meaningful target.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 2.970; pooled standard deviation σ = 2.154.
2. n = 2 × (1.96 + 0.842)² × 2.154² / 2.970² = 8.3, rounded up to 9 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 2.97                      # observed difference in means
sigma <- 2.15368057055822                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2796300)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 9 (80% power), 12 (90% power)
 75% of observed effect: n per arm = 15 (80% power), 20 (90% power)
 50% of observed effect: n per arm = 34 (80% power), 45 (90% power)
power.t.test: 9.3 
Simulated power at n = 9 per arm: 0.785 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary outcome and several secondary outcome entries, including thrombosis-indicator results at different timeframes and a cost outcome. Examining several outcomes or timepoints creates a multiplicity issue: even when no true differences exist, repeated testing can increase the chance that one comparison appears unusual by chance. This is a general statistical concern and does not establish that the primary result is false.

The posted comparison p-values are unadjusted. The registry record does not report a correction for multiple testing, a prespecified hierarchy among secondary outcomes, or a strategy for distinguishing confirmatory from exploratory analyses. It also does not report whether the primary result was selected before data review. Without those details, the primary result can be read as the registered main endpoint, while the secondary p-values should be interpreted cautiously and together rather than as separate definitive tests.

Missing-data handling is not reported in the registry record. The primary results list 10 participants in the Bioflo group and 22 in the Palindrome group, while the later thrombosis-indicator and cost summaries list 10 and 20 participants. The record does not explain the difference in counts across outcomes, whether data were unavailable, whether participants withdrew, or how any missing observations were handled. It does not report imputation or a complete-case analysis plan.

The planned analysis population is also not reported. The registry record does not say whether results were analyzed according to randomized assignment, according to treatment received, or under another rule. It gives no participant-flow account to show exclusions or crossovers. These omissions matter because the way participants are included can affect comparability between randomized groups.

There is no detailed statistical analysis plan, no reported interim-analysis plan, and no separate analyses listed. The registry record also does not report sensitivity analyses that could show how conclusions change under alternative assumptions about missing outcomes or endpoint definitions. These gaps do not erase the posted results; they limit assessment of whether analysis choices were prespecified and how robust the results are to those choices.

15. 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.

The posted safety figures show zero participants with a serious adverse event in the Bioflo group and zero in the Palindrome group. The registry also reports zero participants with other adverse events in each group. It lists 0 deaths in the Bioflo group and 3 in the Palindrome group. These are counts in the registry results, not rates adjusted for time under observation.

The safety summaries do not describe the types of serious or other adverse events, the causes of the deaths, the timing of the deaths, or whether any event was considered related to a catheter or study procedure. The registry record also does not explain the difference in group sizes or provide person-time exposure. Therefore, the figures should not be used to infer a causal relationship between catheter assignment and deaths or to compare risk over time.

Zero recorded events in a group does not prove that an event cannot occur; it means none are listed in these posted categories for the participants summarized. The registry lists no top serious adverse-event terms. Given the small enrollment and missing contextual details, the safety figures are descriptive and cannot provide a comprehensive comparison of harms.

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

The result does mean that the posted primary summaries show different average tPA use between the catheter groups at the registered 1-month timeframe. The reported mean was higher in the Palindrome group, and the reported confidence interval for the mean difference is above zero. This describes the data and the statistical comparison presented in the registry record.

It does not mean that every participant in the Palindrome group had more tPA use than every participant in the Bioflo group. Group means can differ even when individual values overlap substantially. The registry does not provide individual observations or a distribution of results, so the amount of overlap between participants cannot be determined from the posted summaries alone.

It does not establish that catheter type caused the difference in thrombosis. Randomization is a useful design feature, but the registry record does not report enough about allocation procedures, participant flow, analysis population, missing data, or endpoint assessment to evaluate all potential sources of bias. The outcome is tPA use as an indicator of catheter thrombosis, not a complete direct count of thrombosis events. The record also does not specify the clinical importance of a difference in this measure.

It does not show that one catheter is better for every outcome. The secondary cost comparison is uncertain, and the available safety summaries lack information about event type, cause, relatedness, and exposure time. Nor does the record establish whether the findings apply to other settings or patient groups. The trial enrolled 32 participants and is marked terminated, with no reason for termination reported.

The result should therefore be understood as a signal in a specific recorded measure, within a small trial whose statistical and operational details are incompletely documented. It can motivate careful consideration of the endpoint and further study, but the registry record alone cannot settle broader clinical, safety, or economic questions.

17. Why This Trial Matters Statistically

This trial illustrates why the exact endpoint matters in a randomized comparison. The outcome is titled as catheter thrombosis rate, but the recorded measure is tPA use as an indicator of thrombosed catheter. A statistical difference in this indicator is not automatically identical to a difference in directly adjudicated thrombosis events. Researchers and readers need to know how the indicator is defined and applied to understand what the estimate represents.

It also demonstrates the distinction between statistical evidence and precision. The primary confidence interval excludes zero, and the unadjusted p-value is small, yet the estimate still has a range of uncertainty and comes from a modest enrollment. Statistical evidence against equal means does not independently establish the size, importance, or reproducibility of a difference.

The record also shows why reporting group counts and missing-data procedures matters. The listed counts vary across outcomes, but the reasons are not explained. Without participant flow and a stated analysis population, it is difficult to assess whether all randomized participants contributed and whether any exclusions could affect the comparison.

Finally, secondary outcomes and safety summaries need context. Related timeframes can show a consistent direction, but they are not independent replications. Unadjusted tests across multiple outcomes should be interpreted carefully, and event counts without causes or exposure time cannot answer all safety questions. Clear reporting of design, analysis, endpoint definitions, and uncertainty is essential to move from a posted result to a well-supported interpretation.

18. 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.

Several limitations are specific to this record. First, the primary outcome uses tPA use as an indicator of catheter thrombosis. The registry does not report the criteria for tPA use, how the measure was collected, or whether thrombosis events were independently assessed. This makes the link between the recorded measure and the underlying complication difficult to evaluate.

Second, the trial is small, with an enrollment of 32, and the primary outcome counts are unequal between groups. The registry record does not explain the allocation ratio, the reason for the group-count difference, or any participant exclusions. It also does not provide baseline characteristics, so the degree of comparability in the observed groups cannot be assessed from these results.

Third, the study is marked terminated, but the reason is not reported in the registry record. The summary describes observation for three to six months, while the primary outcome is listed at 1 month and secondary outcomes at 3 months. The record does not explain actual follow-up by participant or whether termination affected outcome collection. The different counts reported across outcomes are also unexplained.

Fourth, important analysis details are absent: the original sample-size justification, missing-data handling, analysis population, interim-analysis plan, and multiplicity approach are not reported. The registry lists no separate analyses. Without those details, readers cannot fully assess prespecification or robustness.

Finally, the safety results lack event descriptions, causes, relatedness, and exposure-time information. The cost outcome lacks a description of included cost components. These limitations restrict interpretation of thrombosis, safety, and economic findings beyond the posted summaries.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Study to Compare Palindrome vs. BioFlo DuraMax Dialysis Catheters — NCT02796300.
• Registry record last updated 2020-08-13; status last verified 2020-07.
• Results first posted 2020-04-13.
• 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.

22. Record Summary

The registry describes a prospective randomized, unmasked, parallel-group comparison of Bioflo and Palindrome hemodialysis catheters in people with chronic kidney disease. Enrollment was 32, and the study is marked terminated. The reason for termination is not reported in the registry record.

The primary outcome is mean tPA use per month as an indicator of catheter thrombosis. The posted means and comparison show higher average use in the Palindrome group, with a confidence interval above zero. Secondary entries include a later thrombosis-indicator timeframe and cost analysis. Safety summaries list no serious or other adverse events in either group and list 3 deaths in the Palindrome group; the record does not provide context about causes or relatedness.

The registry record does not report the original sample-size rationale, a detailed statistical analysis plan, missing-data methods, or a multiplicity procedure. The results support a description of the posted comparisons, but the endpoint definition and reporting gaps limit broader conclusions.