Purge Vs no Purge in Living Donor Liver Transplantation Recipients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Purge Vs no Purge in Living Donor Liver Transplantation Recipients (NCT02540447), a randomized na study. The primary outcome is Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure.

2. Clinical Question

The registry describes a prospective randomized controlled trial comparing these approaches at graft portal reperfusion. Its stated focus is whether purging graft contents and mesenteric blood into the systemic circulation differs from washing that volume out of the circulation. The posted primary outcome is a continuous measure of blood pressure, not a count of complications or a time-to-event outcome.

The primary comparison is reported as No Purge relative to Purge. The observed mean difference is -8.28 mmHg, with an interval from -10.92 to -5.641 and p < 0.001. This is a statistical comparison of the recorded group means; it does not by itself establish why the groups differed or determine the clinical importance of the difference.

The record also lists biliary complications, ischemia reperfusion injury, postoperative infectious complications, and 3 Months Mortality as secondary outcomes. Those outcomes address different postoperative events and timeframes, so they complement rather than replace the immediate blood-pressure endpoint.

3. Trial Design

The registry identifies NCT02540447 as a completed, prospective randomized controlled trial. Allocation is listed as randomized, masking as double, and the model as parallel. The phase is recorded as NA. The sponsor is Mansoura University. The recorded start is 2013-01 and primary completion is 2014-05.

Enrollment was 80. The posted primary outcome data include 40 participants in the Purge group and 40 in the No Purge group. The arm descriptions concern right-lobe grafts without inclusion of the middle hepatic vein. In the Purge description, the portal vein was completely anastomosed and the right hepatic vein was anastomosed with the recipient hepatic vein apart. In the No Purge description, both vessels were completely anastomosed before portal declamping and the graft preservative contents were washed out. Both descriptions mention cold Custodiol at 4°C.

Random allocation is intended, in general, to reduce systematic differences between treatment groups at the point of assignment. A parallel design means the groups receive different assigned approaches rather than crossing over between them. Double masking indicates that the record classifies the study as masked, but which people were masked and how masking was maintained are not reported in the registry record. The allocation sequence, concealment procedures, and details of implementation are also not reported in the registry record.

The primary outcome is the lowest mean arterial pressure among readings at 1, 3, and 5 minutes after portal declamping. The secondary outcome timeframes include 3 months for biliary complications, 7 days for ischemia reperfusion injury, and 30 days for postoperative infectious complications. The registry also lists 3 Months Mortality as a secondary outcome, but an arm-specific secondary outcome result for mortality is not reported in the registry record.

The record gives no further description of the study sites, eligibility criteria, participant characteristics, or the population included in each analysis. The trial’s original design assumptions and sample-size justification are not reported in the registry record. Consequently, the posted group results can be described, but the record does not permit a full assessment of recruitment, follow-up, masking, or adherence to the planned protocol.

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

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 Lowest 5 Minutes Post-reperfusion Mean Arterial Blood Pressure, measured over 5 minutes post-reperfusion.

The primary endpoint is the lowest of three mean arterial pressure readings recorded at 1, 3, and 5 minutes after portal declamping. It is expressed in mmHg, and the registry labels the summary as a mean with standard deviation. The timeframe is 5 minutes post-reperfusion.

Mean arterial pressure is a continuous measure of blood pressure. In general, recording it at a specified point around reperfusion can describe the immediate hemodynamic response to that event. Selecting the lowest of the recorded readings focuses the endpoint on the minimum observed value in that brief observation window rather than on the average across the readings. This is a description of what the endpoint measures, not a claim about the investigators’ rationale, which is not reported in the registry record.

The posted mean is 66.03 mmHg in the Purge group and 57.75 mmHg in the No Purge group. The standard deviations are 6.13 and 5.91, respectively. The reported mean difference, expressed as No Purge relative to Purge, is -8.28 mmHg. A mean summarizes the group’s central value, while the standard deviation describes the spread of individual measurements around that mean. Neither measure shows the full distribution of readings or how each participant’s pressure changed over time.

This endpoint represents an early, specific measurement after portal declamping. It is distinct from later complications or mortality, and the registry record does not establish that it is a substitute for those outcomes.

7. Results Posted in the Registry

• No Purge: mean 57.75 versus 66.03 on control; difference -8.28 (95% CI -10.92 to -5.64), 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.

Biliary Complications (Participants)

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • No Purge: 15.0% (6/40) versus 25.0% (10/40) on control; risk difference -10.0 percentage points (95% CI -27.4 to 7.4), risk ratio 0.60 (0.24–1.49); unadjusted two-proportion z-test p = 0.264.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between No Purge and the control. The interval gives the range of effects that remain compatible with the data.

Ischemia Reperfusion Injury

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • No Purge: 5.0% (2/40) versus 7.5% (3/40) on control; risk difference -2.5 percentage points (95% CI -13.1 to 8.1), risk ratio 0.67 (0.12–3.78); unadjusted two-proportion z-test p = 0.644.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between No Purge and the control. The interval gives the range of effects that remain compatible with the data.

Post-operative Infectious Complications

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • No Purge: 20.0% (8/40) versus 22.5% (9/40) on control; risk difference -2.5 percentage points (95% CI -20.4 to 15.4), risk ratio 0.89 (0.38–2.07); unadjusted two-proportion z-test p = 0.785.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between No Purge and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes address postoperative events at different timeframes from the primary blood-pressure endpoint. Across the posted comparisons, the observed risk-difference estimates are negative for No Purge relative to Purge, but the associated intervals are broad and include zero. The estimates therefore do not provide precise evidence of a consistent difference in these complications. They also do not directly test the same question as the immediate post-reperfusion pressure comparison.

The primary result has a more clearly directional interval for its continuous endpoint, whereas the secondary binary outcomes are less precise. This is not a contradiction: a short-term continuous measure and postoperative event counts have different scales, event frequencies, and sources of uncertainty. A result on one endpoint does not imply a corresponding result on the others, and the primary finding cannot be used to fill gaps in the secondary evidence.

The registry lists 3 Months Mortality among the secondary outcomes, but arm-specific mortality results for that outcome are not reported in the registry record. The adverse-events summary includes “3 Months Mortality” as a serious term at 10.0%; it does not give an arm-specific mortality comparison there. That safety listing should not be treated as a substitute for a separately reported secondary outcome analysis.

The secondary p-values are unadjusted, and a multiplicity procedure is not reported in the registry record. In general, examining several outcomes increases the chance that at least one result may appear notable by chance if each is considered independently. This is why unadjusted secondary findings generally carry less confirmatory weight than a prespecified primary outcome with a clearly described analysis plan. The record does not provide enough detail to determine whether the secondary outcomes were prespecified in a particular hierarchy or how their interpretation was intended to be controlled.

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

• Biliary Complications (Participants)
• Ischemia Reperfusion Injury
• Post-operative Infectious Complications
• 3 Months Mortality

9. Statistical Interpretation

10. Statistical Methods Explained

The primary endpoint is continuous: each participant contributes a mean arterial pressure value, measured in mmHg, defined as the lowest of the readings at 1, 3, and 5 minutes after portal declamping. A group mean summarizes the central value of those observations. A standard deviation summarizes how much individual values vary around the group mean. These summaries do not convey every feature of the distributions, such as skewness or unusual observations.

What does a mean difference describe?

The reported contrast is No Purge relative to Purge. A mean difference subtracts one group mean from the other according to that stated comparison. The estimate is -8.28 mmHg. Its negative sign indicates a lower mean for No Purge on this endpoint. The estimate is in the same measurement units as the endpoint, so its scale is interpretable as a difference in mmHg rather than as a standardized score.

The posted group means are 66.03 and 57.75, with standard deviations of 6.13 and 5.91. The comparison also reports a pooled standard deviation of 6.021 and a standardized difference of -1.375. A standardized difference expresses a contrast relative to a measure of variability, which can assist comparisons across measures with different units. It does not replace the original-unit estimate, and it does not establish whether a difference is clinically important.

How should the interval and p-value be read?

The reported interval for the mean difference runs from -10.92 to -5.641. In general, a confidence interval describes the range of values reasonably compatible with the data and the method’s assumptions. It conveys uncertainty about the estimated difference: a narrower interval indicates greater precision than a wider one. The interval level and the specific method used to calculate it are not reported in the registry record, so they should not be inferred from the displayed endpoints.

The p-value is reported as p < 0.001 and is unadjusted. In general, a p-value evaluates how compatible the observed data are with a null model under specified assumptions. It is not the probability that the null hypothesis is true, and it does not measure the size or practical importance of an effect. Because the value is explicitly unadjusted, it should not be interpreted as accounting for testing multiple outcomes.

Why do the secondary outcomes use different comparisons?

The posted secondary outcomes are binary: each outcome is recorded as a participant count. Their comparisons are expressed as risk differences, with No Purge relative to Purge. A risk difference describes the difference between the proportions experiencing an outcome in the groups. The posted estimates are -0.1 for biliary complications, -0.025 for ischemia reperfusion injury, and -0.025 for postoperative infectious complications. These values and their intervals are reported as posted; they are not additional calculations in this explanation.

For binary outcomes, a confidence interval gives a range of plausible differences in event proportions under the analysis method. If an interval includes zero, it is compatible with no difference as well as with values on either side of zero. The three posted secondary risk-difference intervals all include zero. Their unadjusted p-values are 0.264, 0.644, and 0.785, respectively. The record does not list reported secondary analyses beyond the posted comparisons.

What is not specified about the analyses?

The record does not report the method used to calculate the primary interval or p-value, whether the primary comparison was adjusted for any covariates, or how missing measurements were handled. The outcome population and analysis population are not further described. It also does not report a detailed statistical analysis plan, interim analyses, or a multiplicity procedure. These details matter because different analysis choices can affect uncertainty estimates and how multiple results should be interpreted.

In general, random allocation is used to make treatment groups comparable on average, while statistical analysis quantifies the observed contrast and its uncertainty. These protections do not eliminate the need to examine missing data, departures from assigned treatment, and the analysis population. The registry record does not contain enough detail to evaluate those features fully.

11. Confidence Intervals and Precision

The primary mean-difference estimate is -8.28 mmHg, with an interval from -10.92 to -5.641. The entire interval is below zero, so the range of values compatible with the reported interval method points in the same direction as the estimate: a lower mean for No Purge relative to Purge. The interval nevertheless allows uncertainty about the size of that difference. Its level and construction method are not reported in the registry record.

Precision is not the same as importance. A narrow interval can indicate that an estimate is measured with less statistical uncertainty, but it does not say whether the difference matters clinically. Conversely, a statistically uncertain estimate can still include effects that would matter in practice. The registry does not report a threshold for clinical importance for this endpoint, so the observed contrast cannot be classified on that basis from the record alone.

The secondary binary-outcome intervals are wider in relation to their estimates and include zero. For biliary complications, the risk-difference interval runs from -0.274 to 0.074. For ischemia reperfusion injury, it runs from -0.131 to 0.081. For postoperative infectious complications, it runs from -0.204 to 0.154. Each interval permits both a negative and a positive risk difference, as well as no difference. This means the secondary comparisons are imprecise and do not establish a precise direction or magnitude.

Small event counts can make binary-outcome estimates uncertain because a change in a few observed events can substantially alter the estimated group difference. More generally, confidence intervals communicate this uncertainty more fully than a p-value alone. The posted group counts and intervals should therefore be read together, rather than treating a p-value as a complete summary of evidence.

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 planning calculations are illustrations based on the observed effects, not the trial’s original design calculation. The listed figures are participants per arm for 80% power and participants per arm for 90% power; they are not total trial sizes or total event counts. The calculation assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and an effect to detect defined as the stated fraction of the observed effect. The trial’s original sample-size assumptions and justification are not reported in the registry record.

The 80% power column means that, under the planning assumptions and for the selected effect size, a study of the indicated size per arm would have an 80% chance of detecting an effect at the specified significance level if that effect were truly present. The 90% column expresses the corresponding planning target with a higher chance of detection. Greater planned power generally requires more participants, all else held constant.

The rows planning for 100%, 75%, and 50% of the observed effect illustrate how the assumed effect size affects required enrollment. Smaller effects need more participants to distinguish them from random variation. For the primary endpoint, the posted per-arm planning values are 9 and 12 for planning around 100% of the observed effect, 15 and 20 for 75%, and 34 and 45 for 50%, for the 80% and 90% targets respectively. These are planning illustrations and are not observed power.

Such calculations depend on their assumptions. The observed effect can be an uncertain basis for planning, particularly when estimated in a limited study, and the normal approximation may not capture every feature of a future trial. The figures therefore describe hypothetical planning scenarios, not a guarantee that a future study would achieve the stated power or reproduce the observed result.

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 = -8.280; pooled standard deviation σ = 6.021.
2. n = 2 × (1.96 + 0.842)² × 6.021² / -8.280² = 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 <- -8.28                      # observed difference in means
sigma <- 6.02100489951636                     # 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(2540447)
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: 9.4 
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 one primary endpoint and multiple secondary outcomes. The primary comparison is reported with an unadjusted p-value. The secondary comparisons also have unadjusted p-values. A procedure for controlling the chance of false-positive findings across outcomes, such as an adjustment or testing hierarchy, is not reported in the registry record. Without that information, the secondary p-values should be treated as descriptive evidence rather than as a set of independently confirmatory tests.

The analysis plan is not reported in the registry record. It is therefore not possible to determine from the record whether the endpoint definitions, timeframes, comparison methods, or analysis choices were specified before results were known. Interim analyses and stopping rules are also not reported in the registry record. No assumptions about them should be made.

Missing-data handling is not reported in the registry record. The posted primary and secondary results include group sizes, but the record does not explain whether all randomized participants contributed to each outcome, whether measurements were unavailable, or how any unavailable values were handled. The analysis population is not identified as intention-to-treat, per-protocol, or another defined population. Participant flow and adherence to assigned procedures are not reported in the registry record.

These omissions limit assessment of possible bias. For example, if outcome availability differed between groups, the analyzed participants might not fully represent the randomized groups. The record does not say whether such a difference occurred; it simply does not report the information needed to assess it. Likewise, the absence of a stated analysis population does not establish that any particular analysis set was used.

The primary result is consequently interpretable as the posted group comparison, with the reported estimate, interval, and unadjusted p-value. Broader claims about robustness, prespecification, missing outcomes, or multiplicity control cannot be established from the registry record.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: 3 months mortality (10.0%).

The adverse-events summary reports serious adverse events affecting 4 of 40 participants in the Purge group and 3 of 40 in the No Purge group. Other adverse events affected 18 of 40 and 15 of 40, respectively. These are group counts in the registry summary; the record does not give additional detail about event definitions, severity grading, duration, or whether events were considered related to the assigned procedure.

The summary identifies “3 Months Mortality” among the top serious terms at 10.0%, but deaths are not reported by arm in the adverse-events data. Arm-specific mortality counts and a comparative mortality analysis are not reported in the registry record. The listed term should therefore not be interpreted as an arm-level estimate or as a comparison between the groups.

Adverse-event counts describe what was recorded during the trial; they do not by themselves establish that an assigned approach caused or prevented an event. The trial’s enrollment and the number of events also limit how precisely safety differences can be assessed. These summaries should be read alongside the missing detail on event definitions, follow-up, and analysis methods.

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

The posted result shows a difference between the group means for the lowest mean arterial pressure recorded during the 5 minutes after portal declamping. The mean was 66.03 mmHg in the Purge group and 57.75 mmHg in the No Purge group. The reported contrast, No Purge relative to Purge, is -8.28 mmHg, with an interval from -10.92 to -5.641 and p < 0.001. This is evidence of a group difference in the recorded primary measure under the reported comparison.

That result does not, on its own, establish the clinical importance of the difference. The registry does not report a threshold for a meaningful change in this endpoint or connect the short-term measurement to later outcomes. The endpoint is an early blood-pressure summary, whereas biliary complications, ischemia reperfusion injury, infection, and mortality are separate outcomes. A finding for the primary measure should not be carried over as a conclusion about those outcomes.

The secondary results do not establish precise differences in the listed complications: their intervals include zero and are broad. For 3 Months Mortality, an arm-specific outcome result is not reported in the registry record. The adverse-events summary lists mortality as a serious term at 10.0%, but that figure is not an arm-by-arm comparison.

The randomized, double-masked, parallel design is a useful framework for comparing assigned approaches, but details needed to judge implementation and analysis are absent. The registry does not report the analysis population, missing-data handling, full participant flow, or a detailed statistical analysis plan. These gaps mean that the reported estimates can be described, while the extent to which they are robust to analysis choices cannot be assessed from the record alone.

The result is not a recommendation about which procedure to use. It is a report of the statistical evidence for one defined measure in this trial. It does not establish effects in populations or settings not described in the registry, and the record does not provide enough participant or site detail to assess broader applicability.

17. Why This Trial Matters Statistically

This trial illustrates why endpoint choice matters in clinical research. Its primary measure is a continuous, short-term physiologic outcome, summarized by a group mean and standard deviation. The primary comparison has an interval entirely below zero and an unadjusted p-value below 0.001. In contrast, the posted secondary outcomes are binary events with broader intervals that include zero. Those patterns reflect different questions and different amounts of information, not interchangeable measures of a single effect.

It also demonstrates the value of interpreting estimates together with uncertainty. A point estimate gives a concise description of the observed contrast, while an interval indicates how much uncertainty remains. For the primary endpoint, the interval supports a directional difference in the recorded means. For the secondary event outcomes, the intervals admit a broader range of possible differences. Reporting only a p-value would conceal much of that distinction.

The planning illustrations show another statistical issue: sample-size requirements depend on the effect a study is designed to detect. Planning around smaller effects requires more participants under the stated assumptions. The observed effects in a completed study should not be confused with the assumptions used to design it, and the registry does not report the trial’s original sample-size justification.

Finally, the record shows why transparency about analysis populations, missing outcomes, and multiplicity matters. These details help readers judge whether estimates were prespecified, who contributed to each analysis, and how much weight to place on secondary findings. Their absence does not erase the posted results, but it limits the strength of conclusions that can be drawn from them.

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.

The registry record leaves important trial-specific details unavailable. It does not report participant eligibility criteria, baseline characteristics, study-site information, or a full participant-flow account. As a result, it is not possible to assess how closely the enrolled group reflects a broader population of living donor liver transplant recipients or whether the trial involved a single setting.

The trial enrollment was 80, with 40 participants in each arm in the posted primary outcome. That scale permits a description of the observed primary contrast, but the secondary event counts are limited and their intervals are broad. The secondary comparisons therefore have substantial uncertainty. The original sample-size rationale is not reported, and the planning illustrations based on observed effects should not be mistaken for that rationale.

The registry says the design was double-masked but does not identify who was masked or describe how masking was maintained. It does not report allocation concealment, adherence to the assigned procedures, crossovers, or deviations from protocol. These details are relevant when assessing whether the randomized comparison was implemented as intended.

The record also does not report the analysis population, missing-data approach, the method used to calculate the intervals, or a detailed analysis plan. It does not report an arm-specific secondary mortality comparison. These omissions limit assessment of robustness and make the secondary findings less suitable for confirmatory interpretation. They are limitations of what is documented in the registry record, not evidence that a particular problem occurred.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Purge Vs no Purge in Living Donor Liver Transplantation Recipients — NCT02540447.
• Registry record last updated 2017-04-26; status last verified 2016-12.
• Results first posted 2015-10-20.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

NCT02540447 is a completed, prospective randomized, double-masked, parallel trial sponsored by Mansoura University. It compared Purge with No Purge in living donor liver transplantation recipients, with enrollment of 80.

The primary outcome was the lowest mean arterial pressure reading at 1, 3, or 5 minutes after portal declamping. The posted mean difference for No Purge relative to Purge was -8.28 mmHg, with an interval from -10.92 to -5.641 and p < 0.001. Secondary complication comparisons were less precise, and an arm-specific secondary mortality result is not reported in the registry record.

Details on the original sample-size rationale, analysis population, missing-data handling, and multiplicity procedures are not reported in the registry record. The results describe the posted comparisons but do not establish effects on outcomes beyond those reported.