Hemostasis With QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Hemostasis With QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access (NCT03535597), a randomized na study. The primary outcome is Initial Successful Hemostasis.

2. Clinical Question

3. Trial Design

The registry describes a randomized, open-label, sequential-model trial evaluating hemostasis after transradial artery access. The study title frames the comparison as QuikClot Radial pad versus the standard-of-care TR Band. In the posted arm descriptions, the standard-care group used a TR Band inflated with 10 mL of air and gradually weaned over the subsequent 60 minutes. The other groups used a QuikClot Radial pad secured with a Coban bandage, a Tegaderm dressing, or a TR Band.

The registry lists enrollment of 355 and marks the study as completed. The primary completion date is 2022-12-28. The sponsor is Memorial Healthcare System, and coronary artery disease is listed as the condition. The phase entry is NA. Details about the setting, eligibility criteria, recruitment procedures, or whether the analysis followed an intention-to-treat approach are not reported in the registry record.

For the primary outcome, the posted group counts were 85 participants with successful hemostasis among 96 in the TR Band group, 88 among 100 in the pad-with-Coban group, 51 among 73 in the pad-with-Tegaderm group, and 74 among 86 in the pad-with-TR-Band group. These are counts for the outcome, not estimates adjusted for participant characteristics. The registry does not report whether any adjustments were made in the sponsor's analyses.

The record lists three secondary outcomes: radial artery occlusion, forearm hematoma assessed using the EASY Classification, and forearm pain or numbness. Their assessment timeframes vary. Details of masking, stratification, allocation concealment, or the rationale for the sequential model are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: Patients less than 18 years old, acute ST segment elevation myocardial infarction, pregnancy, inability to consent, inability or refusal to allow a follow-up visit or telephone call one business day after the procedure, and arterial access using an ulnar or femoral approach were excluded.

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 Initial Successful Hemostasis, measured over 3 hours.

The primary endpoint, initial successful hemostasis, counts participants meeting the registry's success definition within 3 hours. Success required no evidence of external bleeding from the transradial puncture site or an expanding forearm hematoma after the assigned protocol. It also required that no additional action specified in the definition was needed: reinflation of air in the TR Band, reapplication of manual pressure over the pad, or manual compression over the arteriotomy site.

This endpoint focuses on whether the assigned approach achieves the immediate hemostasis goal without the stated rescue measures. In general, a binary endpoint records whether each participant did or did not meet a defined event criterion during the specified period. Here, the registry reports the number of participants meeting the success definition for each group. It does not provide participant-level records, a separate count of each reason for failure, or detail about the timing of individual failures.

The endpoint allows the three pad configurations to be assessed separately against the TR Band protocol, rather than treating the pad approaches as a single intervention. That distinction matters because the pad was secured using different materials or devices across the groups. The posted results therefore describe each specific configuration in the record, and should not be read as a single estimate for every possible use of the pad.

The endpoint is a procedural outcome measured within 3 hours. It does not by itself summarize longer-term vessel status, symptoms, or all aspects of safety. The registry lists radial artery occlusion, forearm hematoma, and pain or numbness separately as secondary outcomes.

7. Results Posted in the Registry

• Arm 2: 88.0% (88/100) versus 88.5% (85/96) on control; risk difference -0.5 percentage points (95% CI -9.6 to 8.5), risk ratio 0.99 (0.90–1.10); unadjusted two-proportion z-test p = 0.906.
• Arm 3: 69.9% (51/73) versus 88.5% (85/96) on control; risk difference -18.7 percentage points (95% CI -31.0 to -6.4), risk ratio 0.79 (0.67–0.93); unadjusted two-proportion z-test p = 0.002.
• Arm 4: 86.0% (74/86) versus 88.5% (85/96) on control; risk difference -2.5 percentage points (95% CI -12.2 to 7.2), risk ratio 0.97 (0.87–1.09); unadjusted two-proportion z-test p = 0.613.

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.

Radial Artery Occlusion (RAO)

• 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:
  • Arm 2: 4.0% (4/100) versus 5.2% (5/96) on control; risk difference -1.2 percentage points (95% CI -7.1 to 4.7), risk ratio 0.77 (0.21–2.77); unadjusted two-proportion z-test p = 0.686.
  • Arm 3: 5.5% (4/73) versus 5.2% (5/96) on control; risk difference 0.3 percentage points (95% CI -6.6 to 7.1), risk ratio 1.05 (0.29–3.78); unadjusted two-proportion z-test p = 0.938.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm 2 and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm 3 and the control. The interval gives the range of effects that remain compatible with the data.

Forearm Hematoma (EASY Classification)

• 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:
  • Arm 2: 9.0% (9/100) versus 6.2% (6/96) on control; risk difference 2.7 percentage points (95% CI -4.7 to 10.2), risk ratio 1.44 (0.53–3.89); unadjusted two-proportion z-test p = 0.469.
  • Arm 3: 6.8% (5/73) versus 6.2% (6/96) on control; risk difference 0.6 percentage points (95% CI -7.0 to 8.2), risk ratio 1.10 (0.35–3.45); unadjusted two-proportion z-test p = 0.876.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm 2 and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm 3 and the control. The interval gives the range of effects that remain compatible with the data.

Incidence of Pain/Numbness of the Forearm

• 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:
  • Arm 2: 10.0% (10/100) versus 5.2% (5/96) on control; risk difference 4.8 percentage points (95% CI -2.6 to 12.2), risk ratio 1.92 (0.68–5.41); unadjusted two-proportion z-test p = 0.207.
  • Arm 3: 11.0% (8/73) versus 5.2% (5/96) on control; risk difference 5.8 percentage points (95% CI -2.7 to 14.2), risk ratio 2.10 (0.72–6.17); unadjusted two-proportion z-test p = 0.165.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm 2 and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Arm 3 and the control. The interval gives the range of effects that remain compatible with the data.

The secondary outcomes extend the primary procedural endpoint to include radial artery occlusion, forearm hematoma, and pain or numbness of the forearm. Together, they describe additional aspects of vessel status, local tissue findings, and reported symptoms. They do not answer the same question as initial successful hemostasis, and their assessment timeframes differ from the primary endpoint.

Across these outcomes, the sponsor-reported comparisons do not establish a consistent pattern of differences across every pad configuration and every secondary measure. The primary result for one specific pad configuration should therefore not be treated as a summary of all secondary findings. Conversely, the secondary findings do not replace the primary endpoint or establish the comparative performance of the full protocol on their own.

The registry posts sponsor analyses for selected secondary comparisons, but not every possible comparison is represented in those analyses. For example, the posted sponsor analyses do not include an analysis for every secondary endpoint and every pad group. The record does not explain whether this reflects prespecification, data availability, or a reporting decision. That lack of detail limits interpretation of the full set of secondary comparisons.

Unadjusted secondary results carry less weight because multiple outcomes and group comparisons create more opportunities for a chance finding. In general, multiplicity procedures can control error rates across a set of tests, but whether any such procedure was planned or applied is not reported in the registry record. Secondary outcomes are also typically less definitive than a prespecified primary outcome, particularly when events are sparse and confidence intervals are wide. The posted secondary results are best treated as additional descriptive and exploratory evidence, not as independent confirmation of a broad conclusion.

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

• Radial Artery Occlusion (RAO)
• Forearm Hematoma (EASY Classification)
• Incidence of Pain/Numbness of the Forearm

9. Statistical Interpretation

10. Statistical Methods Explained

The posted sponsor analyses use risk ratios to compare the number of participants meeting the primary success definition in each treatment group with the corresponding number in the TR Band group. A risk ratio is a relative measure: a value of 1 indicates equal event proportions in the groups, while values on either side indicate a relative difference. For this endpoint, the event is successful hemostasis, so the ratio must be interpreted as a comparison of success rather than failure.

The sponsor reports chi-squared analyses for the primary outcome. In general, a chi-squared test assesses whether an observed distribution of categorical outcomes is compatible with no association between group and outcome, subject to the test's assumptions. It does not quantify clinical importance. The risk ratio and its confidence interval describe the relative estimate and its uncertainty; the p value describes how unusual the observed data would be under a specified null model. A p value is not the probability that the null hypothesis is true.

The registry's simple recalculations express the primary contrasts as risk differences, a direct absolute-scale comparison between the observed event proportions. A risk difference gives the change in the event proportion between groups, with the sign depending on the order of the comparison. Risk ratios and risk differences answer related but distinct questions: one is relative, and the other is absolute. Because the registry flags a discrepancy between recalculated and sponsor analyses, the sponsor analysis is the appropriate source for the trial's reported inferential findings. The recalculations should not replace the sponsor's results.

For the secondary outcomes, the sponsor reports Fisher exact analyses for the comparisons that are posted. In general, Fisher's exact test evaluates categorical group differences using the observed table and is commonly used when event counts are sparse. The secondary outcomes include events with relatively low counts in the posted groups, so the test method is relevant to interpreting those registry analyses. The sponsor reports risk ratios and confidence intervals for these outcomes as well.

A confidence interval is a range generated by a method that, under its assumptions and repeated use, has a stated coverage rate. It indicates how much uncertainty surrounds an estimate. It is not a range that guarantees the true effect lies within it, and its width is affected by the amount of information and the variability in the data. When an interval spans the null value for a ratio, the data are compatible with no relative difference as well as with effects on either side, within the interval's limits.

The sample-size illustrations use a separate planning calculation, not the trial's reported analysis. The registry describes the planning assumptions as a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The assumed effect is a stated fraction of the observed effect. These illustrations can indicate how the required participants per arm changes under those assumptions; they do not document the trial's original design choices.

Several elements needed to fully evaluate the statistical methods are not reported in the registry record. These include the original statistical analysis plan, the rationale for the planned enrollment, any prespecified primary contrast, whether there were interim analyses, the handling of missing observations, the analysis populations, and whether the reported tests were adjusted for multiplicity. The fact that the study was randomized does not by itself establish how allocation was concealed or how participants were analyzed after randomization. Likewise, open-label status means masking is listed as none, but the registry does not describe whether outcome assessment involved any independent or blinded procedures.

In general, randomization supports a comparison of assigned groups, while masking can help limit some forms of ascertainment or performance bias. These are broad methodological principles, not additional claims about the conduct of this particular trial. The record's limited methodological detail means readers should separate what is explicitly documented from what might ordinarily be part of a protocol.

11. Confidence Intervals and Precision

Precision is about the uncertainty around an estimate, not simply whether a p value is small or large. For the sponsor's primary analyses, the risk-ratio confidence intervals differ in width across comparisons. The reported interval for the Coban comparison runs from 0.89 to 1.11; for the Tegaderm comparison, from 1.09 to 1.53; and for the pad secured with a TR Band, from 0.86 to 1.09. Each interval describes the range of relative effects compatible with the corresponding analysis and its assumptions.

The intervals for the Coban and pad-with-TR-Band comparisons include 1, the value corresponding to equal relative success proportions. They therefore do not pin down a direction of relative difference at the confidence level reported. The Tegaderm comparison's reported interval is entirely above 1 for the sponsor's ratio orientation, which is consistent with the sponsor's reported direction favoring a higher success proportion in the standard TR Band group. This does not establish the clinical importance of the difference.

Precision is limited by the available outcome information. The primary counts are based on groups with differing denominators, and the endpoint is binary. Confidence intervals reflect sampling uncertainty but do not account for unreported sources of bias, deviations from protocol, or missing data. The registry does not report enough detail to assess those issues or to determine whether the intervals were adjusted for the set of comparisons.

In general, a confidence interval is more informative than a point estimate alone because it shows a range of uncertainty. A broad interval can leave substantial uncertainty even if its central estimate appears notable; an interval excluding the null still does not establish a large or meaningful effect. Here, the sponsor's estimates and intervals should be read together, with the registry's discrepancy flag in mind and the sponsor's analysis taking precedence over the simple recalculations.

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 illustrations report participants per arm for 80% power and participants per arm for 90% power. These are not totals across groups and are not observed trial results. The calculation assumptions listed in the registry are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is defined as the stated fraction of the observed effect. The original trial's own design assumptions and sample-size justification are not reported in the registry record.

The 80% power column describes a planning scenario in which, if its assumptions and target effect were correct, a study would have an 80% chance of detecting that effect according to the specified test procedure. The 90% column uses a higher target probability under the same type of planning framework. Neither value is a guarantee for a future study, and neither describes the probability that the observed trial result is true. These figures are planning illustrations, not observed power.

Rows that plan for 100% of the observed effect use that effect as the target; rows that plan for 75% or 50% use smaller target effects. Smaller effects are harder to distinguish from random variation, so the planning calculations require more participants per arm as the target effect gets smaller. The curves express this same general relationship: the required sample size rises as the effect to detect becomes less pronounced.

These values are especially sensitive to the observed effect used as the planning reference. An effect estimated from a trial can be uncertain, and a planning calculation based on it inherits that uncertainty. The illustrations should therefore be read as conditional scenarios under stated assumptions, rather than as a recommendation or as proof that the completed study had a particular level of power.

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, p₀ and p₁ are the control and treatment proportions, and p̄ is their average.

Worked calculation for this trial

1. Control proportion p₀ = 0.885; treatment proportion p₁ = 0.880; average p̄ = 0.883.
2. First term: z_1−α/2 × √[2p̄(1−p̄)] = 1.96 × 0.4550 = 0.8919.
3. Second term: z_1−β × √[p₀(1−p₀) + p₁(1−p₁)] = 0.842 × 0.4550 = 0.3830.
4. n = (0.8919 + 0.3830)² / (-0.0054)² = 55,392.2, rounded up to 55,393 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
p0 <- 0.885416666666667                          # control proportion
p1 <- 0.88                          # treatment proportion
n_per_arm <- function(power, frac = 1) {
  q1 <- p0 + (p1 - p0) * frac               # smaller effect = fraction of the observed difference
  pbar <- (p0 + q1) / 2
  z_b <- qnorm(power)
  ceiling(round((z_a * sqrt(2 * pbar * (1 - pbar)) + z_b * sqrt(p0 * (1 - p0) + q1 * (1 - q1)))^2 / (q1 - p0)^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 (unrounded n per arm)
cat("power.prop.test:", round(power.prop.test(p1 = p0, p2 = p1, power = 0.80)$n, 1), "\n")

# Simulation: how often does the z-test reject at the 80%-power sample size?
set.seed(3535597)
n    <- n_per_arm(0.80)
reps <- 20000
x0 <- rbinom(reps, n, p0); x1 <- rbinom(reps, n, p1)
ph <- (x0 + x1) / (2 * n)
z  <- ((x1 - x0) / n) / sqrt(ph * (1 - ph) * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(z) > z_a, na.rm = TRUE), reps))

Output from running the code

100% of observed effect: n per arm = 55,393 (80% power), 74,154 (90% power)
 75% of observed effect: n per arm = 97,983 (80% power), 131,171 (90% power)
 50% of observed effect: n per arm = 219,351 (80% power), 293,648 (90% power)
power.prop.test: 55392.2 
Simulated power at n = 55,393 per arm: 0.799 (20000 replicates)

The simulation draws many pairs of event counts at the planned sample size and counts how often the two-proportion z-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. Analyses Reported by the Sponsor

The registry posts sponsor-reported risk ratios, confidence intervals, and p values for the primary comparisons. It also contains simple, unadjusted recalculations based on the posted group counts. The discrepancy flag indicates that the recalculated and sponsor-reported results do not fully agree. Under the stated interpretation rule for this record, the sponsor's own analysis takes precedence when reporting the trial's inferential results.

The sponsor analyses use risk ratios and chi-squared tests for the primary outcome, whereas the recalculations express the comparisons as risk differences. Differences in the effect measure and analysis method can produce different numerical summaries, and the registry does not provide enough information to reconstruct every detail of the sponsor's analysis. In particular, the sponsor's full statistical plan and any adjustment procedures are not reported in the registry record.

The sponsor-reported estimates should be understood as the analyses entered in the record, not as proof that all potential analytic concerns were addressed. The group counts remain useful descriptive information, while the sponsor results are the registry's primary inferential results. The existence of a discrepancy is a reason to keep the two kinds of information distinct rather than blending them into one estimate.

15. Multiplicity, Missing Data and Analysis Populations

The record includes a primary outcome, three secondary outcomes, and several pairwise comparisons against the TR Band group. Testing multiple contrasts raises a multiplicity question: when many hypotheses are examined, the chance of at least one apparently unusual result can increase. In general, a prespecified testing hierarchy or multiplicity adjustment can address this issue. Neither a hierarchy nor an adjustment procedure is reported in the registry record, so the posted p values should be interpreted as individual comparisons rather than as multiplicity-controlled results.

The registry does not report whether the primary comparison was selected in advance, whether the three pad configurations were each considered primary contrasts, or whether any analyses were exploratory. It also does not report whether interim analyses were planned or conducted. These details are relevant to interpreting the nominal p values and the possibility of selective emphasis, but cannot be inferred from the posted results.

Missing-data handling is also not reported in the registry record. The outcome counts and denominators are posted, but the record does not describe whether all randomized participants were assessed, how unavailable observations were handled, or whether any participants were excluded from an analysis. An analysis-population definition, such as intention-to-treat or per-protocol, is not reported. The record likewise does not explain whether the denominators reflect the randomized groups, participants with available outcome data, or another analysis set.

These omissions do not demonstrate that a problem occurred. They do mean that the robustness of the comparisons cannot be fully evaluated from the registry record alone. A statistical analysis plan, participant flow information, and explicit descriptions of the missing-data and multiplicity procedures would help clarify how the results were generated and how closely they reflect the randomized comparisons.

16. 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 0% reporting threshold.

The registry's adverse-event entries report 0 serious adverse events and 0 deaths in each of the four groups. It also reports 0 other adverse events in each group. These are the posted counts for the safety fields; they do not imply that every possible symptom or complication was assessed or that no unreported event occurred.

The registry lists the number at risk for each safety category, but does not describe the safety surveillance procedures, event definitions, follow-up duration, or completeness of reporting. The secondary outcomes include radial artery occlusion, forearm hematoma, and pain or numbness, which are posted separately from the adverse-event summary. Their presence illustrates why the adverse-event fields should not be treated as a complete summary of every outcome relevant to safety.

Zero recorded events can still be compatible with uncertainty about uncommon harms, particularly when the available group sizes are limited. In general, the absence of reported events is not equivalent to evidence that an intervention has no risk. The registry entries describe what was recorded in these fields and do not support a broader safety conclusion.

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

The posted results compare four specific hemostasis protocols after transradial artery access: a standard TR Band protocol and three ways of securing a QuikClot Radial pad. For the primary endpoint, the sponsor-reported analysis found a different relative success result for the pad secured with Tegaderm than for the other two pad configurations. The sponsor's reported intervals and p values describe the uncertainty and statistical evidence for those individual comparisons, while the discrepancy flag means that the sponsor analyses take precedence over the simple recalculations.

These findings do not establish that the pad as a general category is better or worse than the TR Band. The three pad groups used different securing approaches and should be considered separately. Nor do the results establish equivalence where an interval includes the null value. A non-small p value does not prove that two protocols perform the same; it can reflect uncertainty, including uncertainty about effects that may still matter.

The outcome is an immediate procedural measure within 3 hours, not a complete assessment of longer-term outcomes. Secondary measures cover vessel occlusion, hematoma, and forearm pain or numbness at their stated timeframes, but they do not provide a full account of all possible benefits or harms. Zero recorded adverse events do not rule out unobserved or uncommon events.

The record does not report the full protocol, analysis plan, missing-data approach, or multiplicity handling. It also does not provide the additional population and setting details needed to judge how broadly the findings apply. As a result, the posted statistics support conclusions about the recorded groups, endpoints, and analyses only; they do not establish a universal clinical effect or settle how the approaches compare in other settings.

18. Why This Trial Matters Statistically

This trial is statistically informative because the intervention is not a single uniform pad protocol. The pad was secured with three different approaches, so separate comparisons preserve the distinction between the configurations rather than hiding potentially different results inside an average. That is particularly important when the primary endpoint is tied to a defined procedural protocol.

The record also illustrates why effect estimates, confidence intervals, and p values should be read together. A p value alone does not convey the size or precision of a comparison. The sponsor's risk ratios and confidence intervals provide a relative estimate and its uncertainty, while the group counts make the underlying event data more concrete. The contrasting results across the three pad configurations show why one should avoid broad conclusions based on the device name alone.

Another statistical lesson is the importance of consistency between posted counts and reported analyses. The registry flags a discrepancy between simple recalculations and sponsor results, so the analyses should not be conflated. The sponsor's own analysis takes precedence, but the discrepancy makes transparent reporting of methods and analysis populations especially valuable.

Finally, the trial has several comparisons and secondary outcomes, while multiplicity and missing-data methods are not reported. This does not invalidate the results, but it changes how confidently isolated findings can be interpreted. Statistical significance, uncertainty, and clinical importance are separate considerations, and the registry provides only part of the information needed to assess them.

19. 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 does not report the eligibility criteria, participant characteristics beyond the listed condition, or study setting. This limits assessment of how closely the enrolled population may resemble other populations undergoing transradial access. It also does not report allocation concealment, details of randomization implementation, protocol deviations, or participant flow through the study.

The study was open label, with masking listed as none. The record does not describe whether outcome assessment was standardized or independently adjudicated. Because the primary endpoint includes judgments about bleeding, hematoma, and the need for additional compression, the absence of information about outcome assessment methods leaves uncertainty about ascertainment.

The record reports group counts and sponsor analyses but does not provide the original statistical analysis plan, the prespecified status of each comparison, missing-data procedures, analysis populations, or multiplicity methods. It also does not report the rationale for planned enrollment or whether interim analyses occurred. These omissions make it difficult to assess the extent to which the posted analyses follow a prespecified plan.

The sponsor analyses for secondary outcomes cover only selected comparisons, and the record does not explain why other combinations are absent. The adverse-event summary reports no events in its listed categories, but surveillance methods and follow-up for safety are not described. Finally, the primary outcome captures initial hemostasis within 3 hours; the record's secondary measures add information but do not resolve every question about longer-term outcomes or uncommon events.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Hemostasis With QuikClot® Radial® Pad Versus TR Band® After Transradial Artery Access — NCT03535597.
• Registry record last updated 2024-09-24; status last verified 2024-07.
• Results first posted 2024-09-24.
• 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.

23. Record Summary

The registry describes a completed, randomized, open-label, sequential-model study of hemostasis after transradial artery access, with enrollment of 355 and Memorial Healthcare System as sponsor. It compares a TR Band protocol with three QuikClot Radial pad configurations, secured with Coban, Tegaderm, or a TR Band.

The primary endpoint was initial successful hemostasis within 3 hours. Sponsor analyses report risk ratios and confidence intervals for each pad comparison against the TR Band group. The Tegaderm comparison has a different reported result from the other two comparisons; the registry flags a discrepancy between sponsor results and simple recalculations, so the sponsor analyses take precedence. Three secondary outcomes are also posted.

The registry reports 0 serious adverse events and 0 deaths in each group. Details about the original analysis plan, multiplicity, missing-data handling, analysis populations, and several aspects of trial conduct are not reported in the registry record.