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 The Evicel Post-Authorization Surveillance Study (NCT01158261), a registered phase not stated study. The primary outcome is Specific Safety Parameters.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01158261 |
| Phase | Phase not stated |
| Condition | Peripheral Vascular Disease, Hemorrhage |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 300 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Ethicon, Inc. |
| Results posted | Yes |
2. Clinical Question
The study asks about the safety of EVICEL Fibrin Sealant (Human) when used as an adjunct to haemostasis in vascular surgery. Its objective is observational: to observe clinical safety performance when EVICEL is used as suture support for haemostasis. The registry lists Peripheral Vascular Disease and Hemorrhage as conditions. It describes a single-arm study, not a comparison of EVICEL with a control treatment.
Population
Vascular surgery subjects treated with EVICEL. Planned enrollment was 300. Participant flow reports that 283 subjects completed the study; one subject lost to follow-up had 4-week information in hospital records.
Intervention
EVICEL Fibrin Sealant (Human), used as an adjunct to haemostasis in vascular surgery. The registry classifies the intervention as biological.
Comparator
No comparator group is described. This is a prospective, single-arm, observational, non-interventional study; allocation is not stated.
Primary question
What incidences of graft occlusion, adverse events potentially related to non-graft thrombotic events, and bleeding events were recorded up to 4-weeks post-operatively?
The registry labels the primary outcome Specific Safety Parameters and defines it in participants. Although the study objective and endpoint identify what was to be observed, the registry record does not report counts for these specific primary safety outcomes. The posted adverse-event information is therefore not a complete answer to the primary question.
3. Trial Design
This was a prospective, single-arm, observational, non-interventional post-authorization safety surveillance study of EVICEL Fibrin Sealant (Human) in vascular surgery. The registry identifies Ethicon, Inc. as the sponsor. The recorded study start is 2010-06, primary completion is 2014-04, and status is COMPLETED. Enrollment was 300.
The study description places EVICEL alongside vascular surgery as an adjunct to haemostasis and as suture support. Because the study is non-interventional and single-arm, it is designed to observe outcomes among people treated with EVICEL rather than to estimate a randomized treatment contrast. The record does not describe a control arm, and allocation is not stated. Consequently, the design does not provide a like-for-like control comparison for attributing observed events to the sealant rather than to surgery, underlying health, or other factors.
The primary outcome is named Specific Safety Parameters. Its stated timeframe is up to 4-weeks post-operatively, and its description lists graft occlusion, adverse events potentially related to non-graft thrombotic events, and bleeding events. The outcome is expressed as a number of participants. The record lists one outcome measure and does not report analyses for it.
Participant flow reports that 283 subjects completed the study. It also notes that one subject lost to follow-up had 4-week information in hospital records. These statements describe flow and record availability, but do not establish how the primary endpoint data were analyzed or how missing information was handled. The registry record does not report a sample-size justification, a detailed statistical analysis plan, or further definitions of the analysis population.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | EVICEL® Fibrin Sealant (Human) |
|---|---|
| STARTED | 300 |
| COMPLETED | 283 |
| NOT COMPLETED | 17 |
Reasons for not completing this period:
| Reason | EVICEL® Fibrin Sealant (Human) |
|---|---|
| Lost to Follow-up | 9 |
| Death | 7 |
| Withdrawal by Subject | 1 |
Analysis population for the primary outcome, as defined in the registry: From participant flow, 283 subjects completed the study; One subject lost to follow-up had 4-week information in hospital records.
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 | EVICEL® Fibrin Sealant (Human) |
|---|---|---|
| Participants analysed | 300 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 151 |
| Age, Categorical: >=65 years | Participants | 149 |
| Age, Continuous | years | 64 (19 to 91) |
| Sex: Female, Male: Female | Participants | 120 |
| Sex: Female, Male: Male | Participants | 180 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 4 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 2 |
| Race (NIH/OMB): Black or African American | Participants | 105 |
| Race (NIH/OMB): White | Participants | 185 |
| Race (NIH/OMB): More than one race | Participants | 4 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 300 |
| BMI (grouped): Underweight | participants | 5 |
| BMI (grouped): Normal | participants | 84 |
| BMI (grouped): Overweight | participants | 79 |
| BMI (grouped): Obese | participants | 108 |
| BMI (grouped): Morbidly obese | participants | 24 |
| History of Smoking: Never smoked | participants | 108 |
| History of Smoking: Ex-smoker | participants | 136 |
| History of Smoking: Current smoker | participants | 56 |
6. Primary Endpoint
The registry lists the primary outcome as Specific Safety Parameters, measured over Up to 4-weeks post-operatively.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is called Specific Safety Parameters and is measured in participants. It concerns three safety outcomes: graft occlusion, adverse events potentially related to non-graft thrombotic events, and bleeding events. The stated observation period is up to 4-weeks post-operatively. In practical terms, the endpoint is intended to describe whether participants experienced these specified events during the stated period.
Safety surveillance is relevant when a product is used in a surgical setting because it can document events observed during clinical use. The listed outcomes include graft-related and other thrombotic events, as well as bleeding, which are the safety parameters named in this study’s registry description. A count of participants with an event can be informative, but its interpretation depends on having clearly reported event definitions, a denominator, follow-up completeness, and an analysis that explains how repeated or overlapping events are treated.
The registry record does not report participant counts for any of the three named primary safety outcomes. It therefore does not provide an endpoint estimate from which the frequency or precision of graft occlusion, non-graft thrombotic events, or bleeding can be assessed. The adverse-event information is separately reported and should not be treated as a substitute for those missing primary endpoint results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s purpose, design, follow-up timeframe, and intended safety outcomes. It does not report the primary endpoint results. In particular, no participant counts are posted for graft occlusion, adverse events potentially related to non-graft thrombotic events, or bleeding events. Without these results, the central safety question cannot be quantified from the registry record.
The adverse-event listing reports 22 participants with serious adverse events among 300 at risk and 23 participants with other adverse events among 300 at risk. These are separate categories in the posted safety information. The record does not establish that the categories are mutually exclusive, so the counts should not be combined. It also does not report whether these events were judged related to EVICEL. The serious-event terms listed include Sepsis, Ateriovenous fistula site complication, and Vascular graft occlusion, each reported as 0.7%; Angina pectoris, Bradycardia, and Cardiac arrest are each reported as 0.3%.
Those term percentages are descriptions in the adverse-event listing, not estimates for the three primary safety outcomes as a whole. A term-level listing does not by itself show the total number of participants with each primary endpoint, how cases were classified, or whether a participant had more than one event. The record does not report a death count.
Precision cannot be judged for the primary endpoint because its event counts and corresponding uncertainty estimates are not reported. A confidence interval, in general, describes the range of values compatible with the observed data under a statistical model; it is not posted for these primary safety outcomes. Likewise, no inferential analysis or p-value for the primary outcome is reported. The registry indicates no analyses, so there is no sponsor-reported primary endpoint analysis to interpret or compare with an independent recalculation.
The single-arm design is also important. Even if event counts were available, an observed event frequency in this cohort would describe outcomes among participants treated in this setting, not a causal difference versus an untreated or alternative-treatment group. Surgery and participants’ clinical circumstances may contribute to events, and the design does not separate those influences. The posted information is best read as a limited safety record: it gives some adverse-event counts and selected serious-event terms, but not the requested primary endpoint results or a comparative estimate.
9. Statistical Methods Explained
The registry describes the primary outcome as a number of participants and lists three safety parameters. This is a binary-outcome framework at the participant level: for each specified event, a participant either is or is not recorded as having that event over the stated observation period. A participant count is not the same as a rate per unit of follow-up time. The registry record does not report a time-to-event analysis for the primary outcome.
What does a participant count represent?
A count gives the number of participants meeting an event definition. To interpret it as a frequency, readers also need the relevant denominator and a clear account of who was eligible for analysis and who had adequate follow-up. The record reports planned enrollment of 300 and participant flow indicating that 283 subjects completed the study; one subject lost to follow-up had 4-week information in hospital records. These registry entries do not establish the denominator used for each endpoint or whether every participant had complete endpoint ascertainment. Endpoint-specific denominators and outcome counts are not reported in the registry record.
When outcomes can overlap, separate participant counts cannot automatically be added. A participant may experience more than one type of event, and the registry does not describe whether events were counted once per participant or how overlapping events were handled across the three parameters. The posted serious and other adverse-event counts are also separate listings; the record does not say that their participant groups are mutually exclusive.
How should uncertainty be understood?
Statistical uncertainty concerns how much an estimate might vary because it is based on a finite group of observations. A confidence interval is a general way to express this uncertainty around an estimated quantity. Narrower intervals indicate greater precision under the chosen method, while wider intervals indicate less precision. No confidence intervals for the primary safety outcomes are reported in the registry record, and the primary event counts needed to interpret such intervals are also absent. General definitions of statistical uncertainty do not fill that reporting gap.
A p-value, in general, evaluates how compatible observed data are with a specified null hypothesis under an analysis model. It does not measure the probability that a treatment is effective or safe. Since this is a single-arm observational study and no primary analysis is posted, the registry record provides no basis for a comparative hypothesis test about EVICEL versus another treatment. It also does not report a p-value for the primary safety outcome.
What do the planning assumptions mean?
The record describes a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two hypothetical arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. For time-to-event illustrations, the reported quantity is the total number of events using the Schoenfeld approach; for other illustrations, it is participants per arm. These are planning assumptions, not a description of how the surveillance study was conducted.
The actual study is single-arm and observational, so equal allocation between two arms is not its design. The planning illustration should not be read as the study’s sample-size justification or as evidence that the study had a particular probability of detecting an effect. Sample-size calculations are planning illustrations, not observed power. The registry record does not report the study’s own sample-size justification or protocol-level statistical plan. No numerical planning result is interpreted because the record details do not state those calculated values.
What can be inferred from the posted analysis status?
The registry lists one outcome measure but reports no analyses. That means the registry record does not provide an inferential analysis of the primary outcome. It does not establish whether analyses were conducted elsewhere, nor does it provide a basis to infer a method that was not recorded. In particular, no adjustment strategy, model, confidence-interval method, or interim-analysis procedure is reported. Any such method would need to be stated in the registry or an analysis report before it could be attributed to this study.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome description includes three safety parameters: graft occlusion, adverse events potentially related to non-graft thrombotic events, and bleeding events. The registry lists one outcome measure, but does not report separate results for the listed parameters. It does not state whether they were treated as separate tests, combined into a composite, or handled under a prespecified hierarchy. A multiplicity adjustment or other strategy for interpreting multiple outcomes is not reported in the registry record.
Participant flow reports that 283 subjects completed the study and that one subject lost to follow-up had 4-week information in hospital records. These details do not show how missing information was handled for each safety parameter, whether hospital records were used in endpoint analysis, or whether all participants had complete follow-up. The registry record does not report endpoint-specific missingness, imputation, sensitivity analyses, or rules for classifying incomplete observations.
The analysis population is also not described beyond the participant-flow information. The record does not report whether the primary outcome used all enrolled subjects, only those with follow-up information, or another defined population. It does not report interim analyses, a detailed analysis plan, or the handling of participants who discontinued or had incomplete records. These omissions limit assessment of selection and missing-data effects. They do not establish that a particular method was or was not used outside the registry record.
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 |
|---|---|---|---|
| EVICEL® Fibrin Sealant (Human) | 22 | 300 | 7.3% |
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 |
|---|---|
| EVICEL® Fibrin Sealant (Human) | 23 of 300 |
Most frequent serious adverse event terms
| Event term | Organ system | EVICEL® Fibrin Sealant (Human) |
|---|---|---|
| Sepsis | Infections and infestations | 2 of 300 |
| Ateriovenous fistula site complication | Injury, poisoning and procedural complications | 2 of 300 |
| Vascular graft occlusion | Injury, poisoning and procedural complications | 2 of 300 |
| Angina pectoris | Cardiac disorders | 1 of 300 |
| Bradycardia | Cardiac disorders | 1 of 300 |
| Cardiac arrest | Cardiac disorders | 1 of 300 |
| Cardio-respiratory arrest | Cardiac disorders | 1 of 300 |
| Cardiogenic shock | Cardiac disorders | 1 of 300 |
| Diarrhoea | Gastrointestinal disorders | 1 of 300 |
| Groin abscess | Infections and infestations | 1 of 300 |
Most frequent non-serious adverse event terms
| Event term | Organ system | EVICEL® Fibrin Sealant (Human) |
|---|---|---|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | 4 of 300 |
| Vascular graft occlusion | Injury, poisoning and procedural complications | 3 of 300 |
| Hypotension | Vascular disorders | 2 of 300 |
| Steal Syndrome | Vascular disorders | 2 of 300 |
| Nodal rhythm | Cardiac disorders | 1 of 300 |
| Nausea | Gastrointestinal disorders | 1 of 300 |
| Graft infection | Infections and infestations | 1 of 300 |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | 1 of 300 |
| Urine analysis abnormal | Investigations | 1 of 300 |
| Fluid overload | Metabolism and nutrition disorders | 1 of 300 |
Serious events with the highest arm-level rate: sepsis (0.7%), ateriovenous fistula site complication (0.7%), vascular graft occlusion (0.7%), angina pectoris (0.3%), bradycardia (0.3%).
The adverse-event listing reports 22 participants with serious adverse events among 300 at risk, and 23 participants with other adverse events among 300 at risk. These are counts of participants with an event, not proof that every event was caused by EVICEL. The registry record does not report an attribution judgment for these categories, and it does not state that the categories are mutually exclusive.
The listed serious-event terms are Sepsis, Ateriovenous fistula site complication, and Vascular graft occlusion, each at 0.7%; Angina pectoris, Bradycardia, and Cardiac arrest are each at 0.3%. These term percentages should be understood as the reported values for the listed terms. They are not a complete summary of the primary endpoint, which includes three specified safety parameters but has no posted participant counts.
The death count is not reported in the registry record. The listed serious adverse events cannot, on their own, establish an overall safety profile or a causal relationship. Interpretation is further limited by the absence of a control group and by the lack of reported endpoint-specific follow-up and analysis details.
12. What the Result Does, and Does Not, Mean
The record shows that a prospective, single-arm surveillance study was completed, with planned enrollment of 300, and identifies the safety outcomes it intended to observe after vascular surgery. The posted adverse-event information includes counts of participants with serious and other adverse events, as well as selected serious-event terms and percentages. These registry entries describe what is recorded; they do not establish that an event was caused by EVICEL.
The record does not report results for the three primary safety parameters. It therefore does not give a quantified answer about graft occlusion, non-graft thrombotic events, or bleeding during up to 4-weeks post-operatively. Nor does it provide uncertainty estimates for those endpoints. The adverse-event listing cannot be substituted for missing endpoint-specific results because the record does not explain how its categories map to the primary outcome definitions.
The study’s single-arm observational design also limits causal interpretation. Without a comparator group, the record cannot estimate how event frequency would differ under another treatment or no use of EVICEL. Events observed in vascular surgery may arise in a clinical context with multiple contributing factors; the study description does not provide a method for separating those contributions.
These limitations do not erase the value of documenting safety observations. They define what the evidence can support: a description of selected adverse-event information in the registry, rather than a comparative treatment effect or a complete estimate of the named primary outcomes. More detailed endpoint counts, definitions, follow-up accounting, and analysis methods would be needed to assess the frequency and precision of those outcomes.
13. Why This Trial Matters Statistically
This study is statistically useful as an example of the distinction between a stated safety objective and reported endpoint results. The registry names the events of interest and the follow-up timeframe, but does not post counts for those primary safety parameters. A clearly specified endpoint is important, yet specification alone does not allow readers to estimate event frequency or precision.
The single-arm observational design illustrates another key distinction: surveillance can describe events observed among treated participants, but it does not create a randomized comparison. Without a comparator, event counts do not estimate a treatment contrast and cannot separate treatment-associated effects from the surrounding surgical and clinical context. This distinction matters when interpreting safety records, where temporal occurrence and causal attribution are not the same.
The record also makes participant flow relevant to analysis. It reports 283 subjects completed the study and notes one subject lost to follow-up with 4-week information in hospital records. Such details help frame questions about ascertainment, but they do not tell readers which participants contributed to each endpoint or how missing data were handled. Transparent denominators and endpoint-specific follow-up accounting are necessary for a clear interpretation.
Finally, the registry’s planning illustration should be kept separate from the conducted study. Its assumptions describe hypothetical planning, including equal allocation between two arms, whereas the surveillance study is single-arm. Treating planning calculations as observed study power or as the actual design would confuse prospective planning with evidence from collected outcomes. Together, these issues show why interpretation depends not just on the named outcome, but also on the design, reporting, denominator, and analysis.
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 most direct limitation is that the registry record does not report results for the primary outcome’s named safety parameters. Without participant counts for graft occlusion, non-graft thrombotic events, and bleeding, their observed frequencies and precision cannot be evaluated from this record.
The study is single-arm and observational, with no comparator group described. It can record safety events in participants treated with EVICEL but cannot provide a like-for-like estimate of outcomes under an alternative approach. Allocation is not stated. The registry also does not report how investigators assessed whether events were related to EVICEL, so causal attribution cannot be inferred from event listings alone.
Participant flow is reported, but endpoint-specific denominators and follow-up completeness are not. The note that one subject lost to follow-up had 4-week information in hospital records does not explain how those records were incorporated into analyses. The record does not report missing-data methods, analysis populations, event definitions beyond the endpoint description, or methods for handling participants with multiple events.
The record lists selected serious adverse-event terms and separate counts for serious and other adverse events, but does not explain whether categories overlap or how the displayed terms relate to the primary endpoint. It does not report a death count, confidence intervals, p-values, or primary outcome analyses. A detailed statistical plan, sample-size justification, interim-analysis procedures, and multiplicity strategy are not reported in the registry record. These limitations concern the available registry information and should not be taken as evidence about methods or results that may exist outside that record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: The Evicel Post-Authorization Surveillance Study — NCT01158261.
- Registry record last updated 2015-08-19; status last verified 2015-07.
- Results first posted 2015-08-19.
- 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
NCT01158261 is the completed EVICEL Post-Authorization Surveillance Study, sponsored by Ethicon, Inc. It is described as a prospective, single-arm, observational, non-interventional study of EVICEL Fibrin Sealant (Human) as an adjunct to haemostasis in vascular surgery. Enrollment was 300; the recorded study start is 2010-06 and primary completion is 2014-04.
The primary outcome, Specific Safety Parameters, concerns graft occlusion, potentially related non-graft thrombotic events, and bleeding up to 4-weeks post-operatively. The registry record does not report results for these primary parameters or analyses. It does report serious adverse events among 22 participants and other adverse events among 23 participants, each among 300 at risk, with selected serious-event terms. Participant flow reports 283 completed subjects and one subject lost to follow-up with 4-week information in hospital records. The single-arm design and incomplete endpoint reporting limit comparative and endpoint-specific interpretation.