This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for TXA Study in Major Burn Surgery (NCT02753816), a randomized na study. The primary outcome is Intraoperative Blood Loss in mL.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02753816 |
| Phase | NA |
| Condition | Tranexamic Acid, Burn, Major Surgery |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 25 |
| Arms in the primary outcome | 2 |
| Lead sponsor | Corewell Health West |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned participants undergoing major burn surgery. The registry record describes burn injury treatment and identifies burn and major surgery among the conditions. It does not report further eligibility details or participant characteristics in the record summarized for this trial.
Intervention
Participants assigned to tranexamic acid were to receive 1 gram intravenously over 10 minutes once before surgery. The research question was whether perioperative tranexamic acid affected blood loss during major burn surgery. The record describes the medication as an intervention under study.
Comparator
The comparator was placebo, given intravenously over 10 minutes once before surgery. The registry describes it as a liquid resembling tranexamic acid but without an active ingredient. The trial is described as placebo-controlled, randomized, and double-blinded; the masking field is recorded as quadruple.
Primary question
The primary outcome was intraoperative blood loss in mL. The stated aim was to determine the impact of perioperative tranexamic acid on blood loss in major burn surgeries. Results are reported as medians and inter-quartile ranges. They describe the posted outcome data, but do not by themselves establish the size or certainty of a treatment effect.
3. Trial Design
The registry record describes a randomized, parallel-group trial comparing tranexamic acid with placebo before burn surgery. Its official title describes it as double-blinded and placebo-controlled; the masking field records quadruple masking. The record does not specify which people involved in the trial were masked, so the exact masking arrangements are not reported in the registry record.
The tranexamic acid regimen was 1 gram given into a vein over 10 minutes once before surgery. The placebo was also given over 10 minutes once before surgery. The record describes both as research interventions. The primary outcome was intraoperative blood loss, measured in mL during surgery; the stated timeframe is intraoperative, average 122 minutes.
Enrollment is recorded as 25. The trial began in 2016-04, has a primary completion date of 2019-12-03, and its status is terminated. The registry record does not explain why the trial was terminated or whether termination was related to recruitment, safety, logistics, or another reason. Those explanations should not be inferred from the status alone.
The record identifies one secondary outcome concerning total length of hospital admission for a large (350 cm2) burn injury. It also records three outcome measures, without clarifying how that count relates to the listed primary and secondary outcomes. A detailed statistical analysis plan, allocation procedure, and planned sample-size justification are not reported in the registry record. The posted outcome results therefore need to be read alongside the limits of the available design and analysis information.
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: Enrolled participants can have multiple surgeries during the course of their stay. This is the reason for the discrepancy between the protocol enrollment and the participant flow.
Overall Study
| Stage | Tranexamic Acid | Placebo | Tranexamic Acid and Placebo |
|---|---|---|---|
| STARTED | 7 | 11 | 7 |
| Tranexamic Acid | 7 | 0 | 7 |
| Placebo | 0 | 11 | 7 |
| COMPLETED | 7 | 10 | 7 |
| NOT COMPLETED | 0 | 1 | 0 |
Reasons for not completing this period:
| Reason | Tranexamic Acid | Placebo | Tranexamic Acid and Placebo |
|---|---|---|---|
| Protocol Violation | 0 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: 1 patient in the Placebo group was excluded from this analysis. Patient was randomized to treatment but never received the treatment intraoperatively. 1 additional patient from the Placebo group was also excluded due to the missing data required to calculate intraoperative blood loss.
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.
| Characteristic | Unit | Tranexamic Acid | Placebo | Tranexamic Acid and Placebo | Total |
|---|---|---|---|---|---|
| Participants analysed | 7 | 11 | 7 | 25 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 7 | 8 | 6 | 21 |
| Age, Categorical: >=65 years | Participants | 0 | 3 | 1 | 4 |
| Age, Continuous | years | 37.2 (23.9 to 51.0) | 53.7 (36.1 to 69.9) | 48.6 (33.8 to 74.6) | 47.6 (23.9 to 74.6) |
| Sex: Female, Male: Female | Participants | 1 | 5 | 1 | 7 |
| Sex: Female, Male: Male | Participants | 6 | 6 | 6 | 18 |
| Race and Ethnicity Not Collected | Participants | — | — | — | 0 |
| Region of Enrollment: United States | Participants | 7 | 11 | 7 | 25 |
6. Primary Endpoint
The registry lists the primary outcome as Intraoperative Blood Loss in mL, measured over Intraoperative, average 122 minutes.
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | mL |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is intraoperative blood loss, measured in mL. It represents the amount of blood lost during the operation, rather than blood loss after surgery or a transfusion outcome. The registry’s stated timeframe is intraoperative, average 122 minutes. The record says the outcome was intended to assess the impact of perioperative tranexamic acid in major burn surgery.
Blood loss is a continuous measurement, but the posted results are summarized with medians and inter-quartile ranges rather than means and standard deviations. A median describes the central observation after values are ordered. The inter-quartile range describes the middle half of the observed values, with its lower and upper limits indicating the spread around the median. These summaries can be useful when observations are skewed or include unusually high values, because the median is less affected by extremes than the mean.
The TXA group’s reported median was 100 mL, with an inter-quartile range of 100 to 200 mL. The placebo group’s reported median was 325 mL, with an inter-quartile range of 200 to 500 mL. The summaries describe the analyzed outcome data; they do not give a confidence interval for a between-group effect or a probability that the observed contrast arose by chance. Neither an inferential test nor an adjusted effect estimate is reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary outcome summaries show a median intraoperative blood loss of 100 mL in the tranexamic acid group and 325 mL in the placebo group. The reported inter-quartile ranges are 100 to 200 mL and 200 to 500 mL, respectively. These are descriptive summaries of the participants included in the outcome analysis. They do not establish the precision of a group contrast, because no confidence interval or inferential test is reported in the registry record.
The inter-quartile ranges give information about the distribution of observed values within each group. They are not confidence intervals for the medians or for a treatment effect. Their position and width help describe the data, but they do not convey all features of the underlying distributions. Individual observations, a model-based estimate, or a test result could add information, but those are not reported in the registry record.
The primary outcome analysis excluded 1 participant in the placebo group who was randomized but did not receive treatment intraoperatively, and 1 additional placebo participant because data required to calculate intraoperative blood loss were missing. The arm summaries report n=14 for tranexamic acid and n=15 for placebo. These analysis counts should not be confused with enrollment, and the record does not state that the analysis followed an intention-to-treat approach. The exclusions are relevant because the posted outcome summaries do not represent every randomized participant in the same way.
The registry status is terminated, but the reason and timing of termination relative to the trial’s plans are not reported in the registry record. The status alone does not show whether the trial ended early, why it ended, or whether the termination affected the outcome analysis. No planned sample-size justification or complete statistical plan is reported, and no test or interval estimate accompanies the primary outcome summaries.
Accordingly, the posted values support a description of the observed distributions in the analyzed groups. They do not, on their own, establish how precisely the groups differ or whether the observed contrast would be expected to persist in another study. The results should be interpreted with the exclusions, the limited analysis detail, and the terminated status in view, without converting descriptive summaries into a definitive treatment conclusion.
9. Statistical Methods Explained
The main outcome is reported using a median and inter-quartile range for each treatment group. The median is the central value when observations are ordered. The inter-quartile range spans the middle half of those observations. Together, these summaries describe a typical value and the spread of the central portion of the data without requiring a normal, symmetric distribution. They do not describe every feature of the data, such as the influence of extreme values or the shape of the full distribution.
What does the median tell the reader?
A median is often useful for clinical measurements that may have a long right tail, where a small number of large observations can pull the mean upward. Blood loss can vary across operations, so a median offers a summary that is less sensitive to unusually high measurements. That general advantage does not establish that the observed data were skewed in this trial; the registry record does not report a distributional assessment. The reported medians are 100 mL for tranexamic acid and 325 mL for placebo.
How should the inter-quartile ranges be read?
The inter-quartile range gives the lower and upper limits of the central half of observed values. For tranexamic acid, the posted limits are 100 and 200 mL; for placebo, they are 200 and 500 mL. These limits describe variation among observations, not uncertainty in the estimated treatment effect. A confidence interval has a different purpose: it expresses uncertainty around an estimate under a statistical procedure. No confidence interval for the primary group contrast is reported in the registry record.
Why does the comparison need more than two medians?
Comparing two medians descriptively does not account for sampling uncertainty. A statistical analysis could estimate a difference in location, compare distributions, or use a model that adjusts for prespecified factors. The appropriate approach depends on the outcome distribution, design, and analysis plan. The registry record does not report the test, model, adjustment variables, or estimate used for the primary comparison. Consequently, the medians should be treated as descriptive evidence, not as a formal test of a treatment effect.
What do randomization and masking contribute?
In general, random assignment is intended to make treatment groups comparable with respect to both measured and unmeasured characteristics, on average. It does not guarantee exact balance in a small trial. Masking can reduce the influence of knowledge of assignment on care, measurement, and assessment. Here, the record describes randomized allocation and placebo control; it calls the trial double-blinded in the title and records quadruple masking in its masking field. The people covered by that description and the implementation details are not reported in the registry record.
How do exclusions affect the analysis?
The primary outcome population omitted 1 placebo participant who was randomized but never received treatment intraoperatively, and 1 additional placebo participant because data needed to calculate the outcome were missing. Missingness can affect results if the likelihood of missing data is related to outcome values or treatment assignment. Excluding a randomized participant who did not receive treatment can also make the analysis population differ from the initially assigned groups. These are general considerations; the record does not explain why the measurement was missing or report analyses testing the effect of these exclusions.
What do the planning illustrations represent?
The sample-size illustrations use the observed effect as a planning reference, with the effect to detect expressed as a fraction of that observed effect. The stated assumptions are a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. These are planning calculations, not observed power and not the trial’s original design justification. Their results depend on the assumptions and effect reference, and they should not be read as evidence that the trial was adequately powered. The registry record does not report the trial’s own sample-size rationale.
What is over-dispersion, in general?
Over-dispersion occurs when the observed variability in data is greater than a statistical model assumes. If a model underestimates variability, its standard errors can be too small and its intervals too narrow. Methods that account for over-dispersion can improve uncertainty estimates for suitable outcomes. This is a general statistical consideration, not a reported feature of this trial: the record does not describe an over-dispersion assessment or a model for the primary endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The primary endpoint is intraoperative blood loss. The registry record also names a secondary outcome concerning total length of hospital admission for a large (350 cm2) burn injury. It records three outcome measures overall, but the relationship between that count and the named outcomes is not clarified. The record does not report a multiplicity adjustment, a hierarchy of outcomes, or a strategy for controlling the chance of false-positive findings across multiple analyses. The effects of multiplicity therefore cannot be assessed from the registry record.
Multiplicity is a general concern when many outcomes or analyses are tested: as the number of tests grows, the chance of at least one apparently notable result can rise if each is interpreted without accounting for the others. This does not mean that any particular posted result is false. It means that the analysis plan and the set of tests are important context. The registry record does not report a full statistical analysis plan, and no inferential analyses are described alongside the primary outcome summaries.
For the primary endpoint, 1 randomized placebo participant was excluded because treatment was not received intraoperatively. Another placebo participant was excluded because data needed to calculate intraoperative blood loss were missing. The record does not state why the data were missing, whether missingness was related to clinical circumstances, or whether any sensitivity analysis was performed. It also does not report imputation or other methods for handling missing outcome data.
These exclusions mean the primary outcome summaries reflect the analyzed groups rather than an identical set of all randomized participants. The record does not identify the analysis population as intention-to-treat, per-protocol, or another prespecified population. That distinction, together with the absence of reported sensitivity analyses, limits assessment of how robust the primary summaries are to the exclusions.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Tranexamic Acid | 2 | 14 | 14.3% |
| Placebo | 1 | 17 | 5.9% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Tranexamic Acid | 1 of 14 |
| Placebo | 0 of 17 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Tranexamic Acid | 0 of 14 |
| Placebo | 0 of 17 |
Most frequent serious adverse event terms
| Event term | Organ system | Tranexamic Acid | Placebo |
|---|---|---|---|
| NSTEMI | Cardiac disorders | 0 of 14 | 1 of 17 |
| Pulmonary Embolism | Vascular disorders | 1 of 14 | 0 of 17 |
| Acute Myocardial Infarction | Cardiac disorders | 1 of 14 | 0 of 17 |
Serious events with the highest arm-level rate: pulmonary embolism (7.1%), acute myocardial infarction (7.1%), nstemi (5.9%).
The registry record lists serious adverse events for the tranexamic acid and placebo groups. The serious-event figures are 2 affected among 14 at risk in the tranexamic acid group and 1 affected among 17 at risk in the placebo group. Deaths are listed as 1 in the tranexamic acid group and 0 in the placebo group. Other adverse events are listed as 0 affected among 14 at risk for tranexamic acid and 0 among 17 at risk for placebo.
The record also lists Pulmonary Embolism at 7.1%, Acute Myocardial Infarction at 7.1%, and NSTEMI at 5.9% among the top serious terms. It does not specify in these figures which treatment group each term belongs to, so they should not be assigned to a group by inference. The record does not provide further detail about timing, duration, severity grading, or the relationship of each event to study treatment.
These counts are descriptive safety information, not a reliable basis for comparing risk. Small numbers of events can vary substantially by chance, and the groups’ at-risk counts differ. The adverse-event figures should not be interpreted as proving that treatment caused or prevented an event. The registry record does not report a formal comparative safety analysis or confidence intervals for these counts.
12. What the Result Does, and Does Not, Mean
The posted results show the observed primary outcome distributions among the participants included in the analysis: the median intraoperative blood loss was 100 mL with tranexamic acid and 325 mL with placebo, with inter-quartile ranges of 100 to 200 mL and 200 to 500 mL. Those values are descriptive. The record does not provide an inferential test, confidence interval, or adjusted estimate for the contrast, so its statistical precision cannot be determined from the reported summaries alone.
The results do not establish a definitive treatment effect. Randomization is an important design feature, but randomization does not eliminate uncertainty, particularly in a trial with enrollment recorded as 25. The outcome analysis also excluded 1 placebo participant who did not receive treatment intraoperatively and 1 because required outcome data were missing. The record does not report whether alternative analysis populations or sensitivity analyses were used.
The outcome concerns blood loss during major burn surgery. It does not directly answer every question about transfusion, postoperative bleeding, hospital admission, or other outcomes. A secondary outcome on total length of hospital admission is identified for a large (350 cm2) burn injury, but its results are not included in the registry record described for this trial. The registry record also lists serious adverse-event counts and terms; these do not by themselves establish causation or a comparative safety profile.
The trial’s terminated status is relevant context, but the record does not report the reason for termination. It should not be assumed that termination reflects a particular efficacy, safety, recruitment, or operational finding. The registry record also does not report a sample-size justification or complete statistical analysis plan. Thus, the posted outcome summaries can be used to describe what was observed, while questions about precision, robustness, and interpretation remain unresolved.
In general, confidence intervals and prespecified analyses help distinguish a plausible range of effects from a point summary, while complete reporting of exclusions and missing-data methods helps readers assess possible bias. Those elements are not reported for the primary comparison in the registry record. The result is therefore best understood as a limited descriptive comparison, not as a stand-alone basis for concluding that tranexamic acid does or does not alter blood loss in this setting.
13. Why This Trial Matters Statistically
This trial illustrates why outcome summaries and uncertainty estimates answer different questions. The reported medians and inter-quartile ranges describe central values and the spread of observed blood loss. They do not quantify how precisely the groups differ. Without a confidence interval or inferential test, readers cannot assess the statistical uncertainty around the comparison from the registry record.
It also demonstrates the importance of identifying the analysis population. The primary outcome analysis excluded 1 randomized placebo participant who did not receive treatment and 1 additional participant with missing data required to calculate blood loss. Such exclusions may be clinically understandable, but their implications depend on why they occurred and how the analysis handled them. Those details and any sensitivity analysis are not reported in the registry record.
The trial’s enrollment is recorded as 25, and its status is terminated. Those details make it especially important not to overinterpret descriptive differences or treat planning calculations as proof of adequate power. The record does not report the original sample-size justification, the reason for termination, or a full statistical analysis plan. The planning illustrations are based on the observed effect and stated assumptions; they are not observed power and do not establish the original design’s intent.
Finally, the record makes clear that safety counts require cautious reading too. Serious adverse events and deaths are listed, but small event counts, differing at-risk counts, and limited detail restrict the conclusions that can be drawn. In statistical terms, transparent reporting of denominators, analysis populations, uncertainty, and outcome selection is essential for interpreting both benefit-related endpoints and safety observations. These features are relevant to understanding what this trial’s posted results can and cannot support.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The record reports enrollment as 25 but does not provide detailed participant characteristics in the registry record described for the trial. The extent to which the participants represent other people undergoing burn surgery cannot therefore be assessed from these details. The trial concerns major burn surgery, and its findings should not automatically be generalized to other procedures or populations.
The primary endpoint summaries are medians and inter-quartile ranges, without a reported confidence interval, inferential test, or adjusted effect estimate. The statistical method used to compare groups is not reported in the registry record. This limits assessment of uncertainty and prevents a reader from determining whether the observed descriptive contrast was evaluated using a prespecified method.
The outcome analysis excluded 1 placebo participant who was randomized but did not receive treatment intraoperatively, and 1 additional placebo participant because required outcome data were missing. The reasons for missing data, handling methods, and sensitivity analyses are not reported. The analysis population is not identified as intention-to-treat or by another named approach.
The trial is listed as terminated, but the record does not give the reason. No sample-size justification, full statistical analysis plan, multiplicity approach, or detailed masking arrangements are reported. The record identifies a secondary hospital-admission outcome but does not include its result in the registry record. These reporting gaps limit assessment of planned versus posted analyses and of the completeness of outcome reporting.
For safety, event counts and top serious-event terms are listed, but the record does not detail the group attribution of each top term, timing, or a formal comparative analysis. The figures therefore support only cautious description, not causal conclusions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: TXA Study in Major Burn Surgery — NCT02753816.
- Registry record last updated 2021-08-23; status last verified 2021-04.
- Results first posted 2021-08-23.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT02753816 is a randomized, parallel-group, placebo-controlled trial titled TXA Study in Major Burn Surgery. The registry describes tranexamic acid given once before surgery as 1 gram intravenously over 10 minutes and records placebo as the comparator. The title describes double blinding, while the masking field records quadruple masking.
Enrollment is recorded as 25. The trial began in 2016-04, has a primary completion date of 2019-12-03, and is listed as terminated. The primary outcome is intraoperative blood loss in mL, summarized by medians and inter-quartile ranges. The record notes two placebo-group exclusions from that outcome analysis: 1 participant who did not receive treatment intraoperatively and 1 with missing data needed to calculate blood loss.
The registry also lists a secondary hospital-admission outcome and serious adverse-event information. The reason for termination, full statistical analysis plan, sample-size justification, and inferential results for the primary comparison are not reported in the registry record.