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 Fibrin Sealant Vascular Surgery Study (NCT00576420), a randomized phase 2 study. The primary outcome is Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00576420 |
| Phase | Phase 2 |
| Condition | Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts) |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 101 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Baxter Healthcare Corporation |
| Results posted | Yes |
2. Clinical Question
Population
Participants undergoing vascular surgery with prosthetic expanded polytetrafluoroethylene (ePTFE) conduits. The primary outcome population is identified as Intent to Treat. The record lists an enrollment of 101.
Intervention
FS VH S/D 500 s-apr applied to the study suture line, assessed with a 60-second polymerization time or a 120-second polymerization time.
Comparator
Manual compression of the study suture line with surgical gauze pads.
Primary question
What percentage of participants achieved maintained hemostasis at the study suture line at 4 minutes after treatment application, comparing the fibrin sealant approaches with manual compression?
The registry describes a randomized, parallel-group comparison with three treatment arms: the two sealant polymerization times and the manual-compression control. The primary endpoint is defined as hemostasis at the suture line at 4 minutes. A participant was considered a treatment failure for not achieving hemostasis by that time, requiring additional hemostatic treatment during the first 4 minutes, or experiencing rebleeding after the first 4 minutes of observation.
The primary endpoint results, including the arm-level percentages and a comparative estimate, are not reported in the registry record. The study purpose and endpoint definition therefore establish the question being asked, but do not establish the observed answer. Safety counts are reported separately and should not be treated as substitutes for the primary efficacy outcome.
3. Trial Design
The study is identified as a Phase 2 randomized, single-masked, parallel-group trial. Its listed enrollment is 101, and its status is completed. The registry lists the study start as 2007-12 and primary completion as 2008-11. Baxter Healthcare Corporation is the sponsor.
The three arms compare FS VH S/D 500 s-apr applied to the study suture line with either a 60-second or 120-second polymerization time against manual compression with surgical gauze pads. The study purpose is to evaluate efficacy and safety for hemostasis in participants receiving prosthetic ePTFE conduits during vascular surgery. The identity of the party or parties masked is not reported in the registry record. The allocation ratio and details of the randomization procedure are also not reported in the registry record.
The primary outcome is the percentage of participants achieving maintained hemostasis at the study suture line at 4 minutes after treatment application. The registry identifies its analysis population as Intent to Treat. The primary endpoint definition includes failure criteria related to failure to achieve hemostasis, additional treatment during the first 4 minutes, and rebleeding after the first 4 minutes of observation.
The registry lists secondary outcomes involving hemostasis at 6 and 10 minutes, intraoperative and postoperative rebleeding, transfusion requirement, graft occlusions, surgical-site infections, and preoperative systolic and diastolic blood pressure. Across the record, there are 27 outcome measures and 15 analyses. The full statistical protocol, including any planned covariate adjustment or detailed analysis procedures, is not reported in the registry record. The reported enrollment does not identify how participants were distributed across the three arms.
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: 101 participants were enrolled and screened. 26 were screen failures; 1 was excluded due to study issue; and 1 was withdrawn by investigator. Therefore, 73 of the 101 enrolled were randomized and treated.
Overall Study
| Stage | FS VH S/D 500 S-apr - 60 Seconds | FS VH S/D 500 S-apr - 120 Seconds | Control Group |
|---|---|---|---|
| STARTED | 26 | 24 | 23 |
| COMPLETED | 26 | 24 | 22 |
| NOT COMPLETED | 0 | 0 | 1 |
Reasons for not completing this period:
| Reason | FS VH S/D 500 S-apr - 60 Seconds | FS VH S/D 500 S-apr - 120 Seconds | Control Group |
|---|---|---|---|
| Death | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: Intent to Treat
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 | FS VH S/D 500 S-apr - 60 Seconds | FS VH S/D 500 S-apr - 120 Seconds | Control Group | Total |
|---|---|---|---|---|---|
| Participants analysed | 26 | 24 | 23 | 73 | |
| Age Continuous | years | 63.0 (full range 12.7) | 67.0 (full range 14.6) | 63.0 (full range 14.4) | 63 (24 to 86) |
| Sex: Female, Male: Female | Participants | 5 | 12 | 12 | 29 |
| Sex: Female, Male: Male | Participants | 21 | 12 | 11 | 44 |
| Region of Enrollment: United States | participants | 26 | 24 | 23 | 73 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line., measured over 4 minutes post start of treatment application.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants who achieve and maintain hemostasis at the study suture line at 4 minutes after treatment application. It focuses on bleeding control at the surgical site where treatment is applied, making it a direct measure of the stated purpose of the study. The registry identifies the analysis population as Intent to Treat.
The definition counts several circumstances as treatment failure: not achieving hemostasis at 4 minutes, needing additional hemostatic treatment during the first 4 minutes of observation, or experiencing rebleeding after the first 4 minutes. Thus, the outcome is not simply whether bleeding appears controlled at one instant. Its definition also accounts for the need for further treatment and subsequent rebleeding. The endpoint is binary at the participant level—achievement or failure—then expressed as a percentage of participants.
As a general statistical point, a binary endpoint can communicate the frequency of an event or successful outcome in each treatment group. A comparison between groups can then describe the observed difference in those frequencies, with an interval estimate conveying uncertainty when one is reported. Such estimates are not reported for this endpoint in the registry record. The endpoint definition and intended population are reported, but numerical group results and a single comparative estimate are not. Consequently, the endpoint clarifies what the trial set out to measure without establishing the size or precision of any treatment-group contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The study asks whether hemostasis at the study suture line is achieved and maintained at 4 minutes after application of FS VH S/D 500 s-apr, comparing two polymerization times with manual compression. The primary outcome is a participant-level percentage, and the registry identifies the analysis population as Intent to Treat. However, the numerical primary outcome results are not reported in the registry record. No arm-specific primary percentages, contrast, confidence interval, or primary-outcome test result is available in the stated details. The registry record therefore does not support a quantitative interpretation of the primary efficacy comparison.
The registry indicates that the primary outcome has several categories or time points and is not reduced to one comparison. That matters for interpretation: a reader should not assume that a single summarized contrast represents every outcome category or time point. The endpoint definition itself specifies a four-minute assessment and failure conditions, while the record separately names hemostasis outcomes at 6 and 10 minutes. Without the corresponding results and analysis details, the relationship among those outcomes cannot be assessed.
The record reports safety counts by group. For serious adverse events, it lists 4 affected participants among 26 at risk in the 60-second fibrin sealant group; 4 among 24 in the 120-second group; 8 among 50 in the combined fibrin sealant group; and 4 among 23 in the control group. It also lists other adverse-event counts of 4 among 26, 9 among 24, 13 among 50, and 7 among 23, respectively. These are descriptive counts, not estimates of a causal treatment effect. The combined fibrin sealant group is reported alongside the two separate sealant groups, and the counts should be read using the group labels rather than treated as independent comparisons.
The registry lists six serious adverse-event terms, each at 4.3%: myocardial infarction, ventricular fibrillation, gastrointestinal haemorrhage, dehydration, pulmonary oedema, and peripheral vascular disorder. The basis for these percentages and whether participants could contribute to more than one term are not reported in the registry record. Death counts are not reported in the registry record.
As a general statistical point, estimates from a randomized comparison are more informative when accompanied by uncertainty intervals and a clear description of the analysis population and methods. Those details help distinguish an observed difference from the uncertainty around it. Since the numerical primary-outcome estimates and their uncertainty are not reported, neither the direction nor the precision of the primary contrast can be described from this record. The listed safety counts likewise do not, by themselves, establish whether groups differed beyond what could arise from sampling variability.
9. Statistical Methods Explained
The record describes a randomized, parallel-group study with three arms and a single masking designation. Randomization is generally used to assign participants to treatment groups in a way intended to reduce systematic differences between groups at the start of a trial. A parallel-group design means participants are assigned to one group rather than receiving each treatment in sequence. The identity of the party or parties masked, the allocation ratio, and the details of how randomization was implemented are not reported in the registry record.
What does a percentage endpoint represent?
The primary outcome is the percentage of participants achieving hemostasis at 4 minutes after treatment application, with hemostasis required to be maintained under the endpoint definition. The registry classifies the outcome as a participant-level event measure. In general, a percentage for a binary outcome describes the share of participants in a group who meet the specified outcome definition. A treatment-group comparison may be expressed on different scales, such as a difference in percentages or a ratio of percentages; which scale is most useful depends on the question and analysis plan. No comparative primary estimate is reported in the registry record, so no particular scale can be interpreted for this trial.
For this endpoint, the definition includes both failure to reach hemostasis at 4 minutes and additional failure conditions involving treatment during the first 4 minutes or later rebleeding. These criteria make it important to use the registry definition when interpreting any eventual percentage. A result based on a different definition could represent a different outcome. The record does not report the participant-level outcome counts needed to reconstruct the primary percentages.
Why do uncertainty intervals matter?
General explanation: a confidence interval gives a range of values compatible with the data and the method used to calculate it. It communicates uncertainty in an estimate and is often more informative than a point estimate alone. A narrow interval indicates greater precision than a wide interval, while the interval's location helps show which effect sizes remain plausible under the method. No confidence interval for the primary endpoint is reported in the registry record. Without one, the precision of the primary comparison cannot be evaluated.
A p-value, when included, addresses compatibility between observed data and a specified null model under the assumptions of the test. It is not the probability that a treatment works, nor does it measure the size or clinical importance of an effect. No primary-outcome p-value is reported in the registry record. The absence of a reported test result should not be replaced with an inference from the enrollment or from safety counts.
How should the planning assumptions be read?
The record describes a sample-size planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The planning illustration is stated to use the effect to detect as a fraction of the observed effect. For time-to-event tables, the described quantity is total events; for other tables, it is participants per arm. Numerical planning values are not reported in the registry record for this analysis.
General explanation: sample-size planning asks how many participants or events would be needed under specified assumptions to detect a chosen effect with a stated probability of statistical significance. A planning illustration is conditional on its assumptions and is not an observed trial result. It is not observed power. In particular, if a planning illustration uses an effect estimated from the same trial, the resulting values should not be treated as independent evidence about the treatment effect. They do not replace the trial's actual outcome estimates and uncertainty intervals.
The registry enrollment is 101, but that is not equivalent to the number analyzed for each endpoint or the number assigned to each arm. Group-specific denominators may vary, and the registry record does not report the primary endpoint counts or missingness information in the stated details. Therefore, no arm-level event rate or precision measure can be derived from the overall enrollment.
Why can over-dispersion matter?
General explanation: over-dispersion occurs when observed variability is greater than a statistical model assumes. If a model underestimates variability, its standard errors and uncertainty intervals may be too small, and tests may appear more decisive than warranted. This is a general consideration for some types of outcome models; the primary endpoint is described as a binary participant percentage. The statistical model used for the primary analysis, and any assessment of over-dispersion, are not reported in the registry record. It would therefore be inappropriate to claim that over-dispersion was present or that a particular correction was used.
The record lists 27 outcome measures and 15 analyses, along with secondary outcomes at different time points and for different events. General explanation: multiple outcomes or repeated tests create a multiplicity question because the chance of at least one apparently unusual result can increase when many hypotheses are examined. Methods such as prespecifying a primary endpoint, adjusting for multiple tests, or treating secondary results as exploratory can address different parts of this issue. Which approach was prespecified or applied is not reported in the registry record. The outcome count alone does not establish that an adjustment was needed or used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 27 outcome measures and 15 analyses. It identifies one primary endpoint: the percentage of participants achieving hemostasis at 4 minutes after treatment application. It also lists secondary outcomes at 6 and 10 minutes, rebleeding outcomes, transfusion requirement, graft occlusions, surgical-site infections, and preoperative blood pressure measures. The record's primary outcome is described as having several categories or time points and not being reduced to one comparison. This makes it important to distinguish the endpoint definition from any single statistical contrast.
General explanation: when several outcomes, time points, or comparisons are examined, the analysis plan should clarify which results are confirmatory and whether any adjustment or hierarchy is used. Without that information, an isolated statistically unusual result can be difficult to interpret in the context of all the analyses. Any prespecified multiplicity strategy, adjustment method, or distinction between confirmatory and exploratory analyses is not reported in the registry record.
The primary outcome analysis population is identified as Intent to Treat. The registry does not report, in the stated details, the number analyzed by arm, missing primary-outcome data, reasons for missingness, or how missing outcomes were handled. It also does not report details of exclusions or any sensitivity analyses for missing data. As a general matter, missing-data handling can affect an estimated group percentage when outcome status is unknown for some participants, and the assumptions used should be stated.
The available information does not establish whether the stated Intent to Treat population was applied to every analysis or how it was operationalized. Nor does it establish whether secondary outcomes used the same population. These details are not reported in the registry record. Accordingly, no claim can be made about the effect of missing-data methods or multiplicity control on the study's findings.
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 |
|---|---|---|---|
| Fibrin Sealant - 60 Seconds | 4 | 26 | 15.4% |
| Fibrin Sealant - 120 Seconds | 4 | 24 | 16.7% |
| Fibrin Sealant All - (60 + 120 Seconds) | 8 | 50 | 16.0% |
| Control Group | 4 | 23 | 17.4% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Fibrin Sealant - 60 Seconds | 4 of 26 |
| Fibrin Sealant - 120 Seconds | 9 of 24 |
| Fibrin Sealant All - (60 + 120 Seconds) | 13 of 50 |
| Control Group | 7 of 23 |
Most frequent serious adverse event terms
| Event term | Organ system | Fibrin Sealant - 60 Seconds | Fibrin Sealant - 120 Seconds | Fibrin Sealant All - (60 + 120 Seconds) | Control Group |
|---|---|---|---|---|---|
| Incision site haematoma | Injury, poisoning and procedural complications | 1 of 26 | 1 of 24 | 2 of 50 | 0 of 23 |
| Graft thrombosis | Injury, poisoning and procedural complications | 1 of 26 | 0 of 24 | 1 of 50 | 0 of 23 |
| Hyperglycaemia | Metabolism and nutrition disorders | 1 of 26 | 0 of 24 | 1 of 50 | 0 of 23 |
| Metabolic acidosis | Metabolism and nutrition disorders | 1 of 26 | 0 of 24 | 1 of 50 | 0 of 23 |
| Vascular graft complication | Injury, poisoning and procedural complications | 0 of 26 | 1 of 24 | 1 of 50 | 0 of 23 |
| Vascular graft occlusion | Injury, poisoning and procedural complications | 0 of 26 | 1 of 24 | 1 of 50 | 0 of 23 |
| Wound | Injury, poisoning and procedural complications | 0 of 26 | 1 of 24 | 1 of 50 | 0 of 23 |
| Myocardial infarction | Cardiac disorders | 0 of 26 | 0 of 24 | 0 of 50 | 1 of 23 |
| Ventricular fibrillation | Cardiac disorders | 0 of 26 | 0 of 24 | 0 of 50 | 1 of 23 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 0 of 26 | 0 of 24 | 0 of 50 | 1 of 23 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Fibrin Sealant - 60 Seconds | Fibrin Sealant - 120 Seconds | Fibrin Sealant All - (60 + 120 Seconds) | Control Group |
|---|---|---|---|---|---|
| Incision site complication | Injury, poisoning and procedural complications | 2 of 26 | 2 of 24 | 4 of 50 | 0 of 23 |
| Incision site oedema | Injury, poisoning and procedural complications | 2 of 26 | 1 of 24 | 3 of 50 | 1 of 23 |
| Oedema peripheral | General disorders | 0 of 26 | 2 of 24 | 2 of 50 | 2 of 23 |
| Incision site erythema | Injury, poisoning and procedural complications | 0 of 26 | 2 of 24 | 2 of 50 | 1 of 23 |
| Ventricular tachycardia | Respiratory, thoracic and mediastinal disorders | 0 of 26 | 2 of 24 | 2 of 50 | 0 of 23 |
| Pyrexia | General disorders | 0 of 26 | 2 of 24 | 2 of 50 | 0 of 23 |
| Anxiety | Psychiatric disorders | 0 of 26 | 0 of 24 | 0 of 50 | 2 of 23 |
| Diarrhoea | Gastrointestinal disorders | 0 of 26 | 0 of 24 | 0 of 50 | 2 of 23 |
Serious events with the highest arm-level rate: myocardial infarction (4.3%), ventricular fibrillation (4.3%), gastrointestinal haemorrhage (4.3%), dehydration (4.3%), pulmonary oedema (4.3%).
The registry reports serious adverse-event counts and other adverse-event counts by treatment group. For serious adverse events, the listed figures are 4 of 26 at risk for the 60-second fibrin sealant group, 4 of 24 for the 120-second group, 8 of 50 for the combined fibrin sealant group, and 4 of 23 for the control group. For other adverse events, the corresponding counts are 4 of 26, 9 of 24, 13 of 50, and 7 of 23. These are counts of affected participants and the listed at-risk group sizes; they are not comparative effect estimates.
The combined fibrin sealant group is a separate registry entry covering the 60- and 120-second groups together. Its count should not be interpreted as an additional independent treatment arm alongside both component arms. The six listed serious adverse-event terms—myocardial infarction, ventricular fibrillation, gastrointestinal haemorrhage, dehydration, pulmonary oedema, and peripheral vascular disorder—are each reported as 4.3%. The registry record does not report the basis for those percentages or whether an individual participant could be represented under more than one term. Death counts are not reported in the registry record; a missing death count should not be read as a count of zero.
General explanation: adverse-event counts describe events observed during the study, but a count alone does not show whether an event was caused by a treatment. Interpretation also depends on definitions, observation periods, participant follow-up, and the analysis used to compare groups. Those details and a formal between-group safety comparison are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes the trial question, design, endpoint definition, and some safety counts. It does not report numerical results for the primary endpoint. The percentage achieving maintained hemostasis at 4 minutes, the corresponding group comparisons, and their statistical uncertainty are not reported in the registry record. Therefore, this record cannot quantify the primary treatment contrast or indicate how precisely it was estimated.
The outcome definition is clinically focused on control of bleeding at the study suture line, and it includes additional treatment and rebleeding criteria in its failure definition. That makes the measurement more specific than a simple notation that hemostasis was observed at one time. Yet the relevance of that definition does not supply the missing outcome results. The registry also names later hemostasis assessments and other secondary outcomes, but their numerical results are not reported in the stated details.
The safety entries show that serious and other adverse events were recorded in each listed group. They are descriptive counts with group sizes, not proof that one group had more or fewer treatment-related harms. The listed serious adverse-event terms are reported at 4.3% each, and the registry record does not explain their percentage basis. Death counts are not reported in the registry record. These limitations mean that the safety information should be read narrowly as the listed observations, not as a complete comparative safety analysis.
General explanation: a randomized trial can support a comparative interpretation when its outcome estimates, uncertainty, analysis population, and analytic methods are reported and considered together. Statistical significance alone, if reported, would not establish the size or clinical importance of a difference. Conversely, a nonsignificant test would not by itself demonstrate equivalence. Here, the numerical primary results and associated uncertainty are not reported, so neither conclusion can be drawn from the stated information. The registry entries also do not establish why the trial enrolled 101 participants or whether that enrollment was sufficient for a particular effect size.
The study is completed, but completion status is not itself evidence about the direction or magnitude of an outcome. The defensible interpretation is limited to what the registry reports: the planned comparison involved sealant at two polymerization times and manual compression, with hemostasis at 4 minutes as the primary endpoint and specified safety counts. The comparative primary result remains unreported.
13. Why This Trial Matters Statistically
This trial is statistically notable for separating two treatment features in the intervention arms: FS VH S/D 500 s-apr was applied with a 60-second or 120-second polymerization time. Both were compared with manual compression using surgical gauze pads. A three-arm randomized parallel design can frame separate questions about each sealant approach relative to control, as well as questions about the two sealant times. The registry information does not specify the planned contrast structure or whether comparisons between all arms were intended.
The primary outcome also illustrates why outcome definitions matter. It measures maintained hemostasis at the study suture line at 4 minutes and identifies additional treatment and later rebleeding as failure conditions. Such criteria affect which participants count as achieving the endpoint. Reporting the definition helps readers understand the intended estimand, although the numerical results are not reported in the registry record.
The record lists numerous outcome measures and analyses, with hemostasis assessed at multiple times and additional outcomes covering rebleeding, transfusion, graft occlusion, infection, and blood pressure. This makes transparent reporting of the prespecified primary comparison, secondary analyses, missing-data handling, and multiplicity approach particularly important. Those methods are not reported in the registry record.
The statistical lesson is that a completed randomized study and a clear endpoint definition do not alone allow an efficacy conclusion. Readers need the outcome counts or estimates and information about their uncertainty to assess the evidence. Safety counts can describe observed events, but they do not answer the primary efficacy question or independently establish causation. This record therefore illustrates both the value of precise endpoint definitions and the limits of interpretation when comparative outcome estimates and analytic details are not reported.
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 main trial-specific limitation for interpreting efficacy is that numerical primary-outcome results are not reported in the registry record. Arm-level hemostasis percentages, the primary comparative estimate, uncertainty intervals, and a test result are not available in the stated details. Although the endpoint and Intent to Treat population are identified, the number contributing to each arm's endpoint analysis is not reported. The overall enrollment of 101 cannot establish those group-specific denominators.
Several design and analysis details are also not reported: the allocation ratio, the randomization procedure, the identity of the party or parties masked, and the statistical model or test used. The record does not describe any covariate adjustment, missing-data approach, sensitivity analyses, or multiplicity strategy. It also does not state the sample-size justification used for the trial. A planning illustration is described separately, but numerical planning values are not reported in the stated details and should not be confused with the trial's design justification.
The registry lists safety counts, but the registry entries do not provide event definitions, the duration of safety observation, or a formal group comparison. The basis for the percentages attached to the serious adverse-event terms is not reported, nor is it clear from the record whether those terms could overlap at the participant level. Death counts are not reported in the registry record.
Finally, the record identifies secondary outcomes and reports 27 outcome measures and 15 analyses, but the stated details do not supply numerical results for those endpoints. Without those results and an account of how the analyses were prioritized, the breadth of the outcome assessment cannot be fully evaluated. These limitations concern the information available in the registry record; they do not establish that the unreported procedures or results were absent from study conduct.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Fibrin Sealant Vascular Surgery Study — NCT00576420.
- Registry record last updated 2012-11-27; status last verified 2012-10.
- Results first posted 2012-11-27.
- 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
NCT00576420 is a completed, randomized, single-masked, parallel-group Phase 2 study sponsored by Baxter Healthcare Corporation. Its listed enrollment is 101. The study evaluates FS VH S/D 500 s-apr applied at the study suture line with 60-second or 120-second polymerization times, compared with manual compression using surgical gauze pads, in participants undergoing vascular surgery with prosthetic ePTFE conduits.
The primary endpoint is the percentage achieving maintained hemostasis at 4 minutes after treatment application, with additional treatment during the first 4 minutes or later rebleeding included in the failure definition. The listed analysis population is Intent to Treat. Numerical primary results and comparative estimates are not reported in the registry record. Safety counts are reported by group, including serious and other adverse-event counts, while death counts are not reported. The record lists 27 outcome measures and 15 analyses; detailed statistical methods, missing-data handling, and multiplicity procedures are not reported in the stated details.