Trial · NCT00576420
Fibrin Sealant Vascular Surgery Study
NCT00576420, Phase 2, Completed, Baxter Healthcare Corporation; results first posted 2012-11-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Fibrin Sealant Vascular Surgery Study. Trials, record NCT00576420. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00576420
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fibrin Sealant Vascular Surgery Study
- NCT number
- NCT00576420
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 101 participants, actual
- Lead sponsor
- Baxter Healthcare Corporation
- Conditions
- Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)
- Interventions
- FS VH S/D 500 s-apr, 60-seconds polymerization time, FS VH S/D 500 s-apr, 120-seconds polymerization time, Manual compression with surgical gauze pads
- First posted
- 2007-12-19
- Last updated
- 2012-11-27
- Results first posted
- 2012-11-27
Source ClinicalTrials.gov
Registered outcomes27
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | 4 minutes post start of treatment application | Hemostasis at the study suture line must be maintained. Participants were considered treatment failures if they met any of the following conditions: * Did not achieve hemostasis at 4 minutes * Required additional hemostatic treatment during the first 4 minutes of the observation period * Experienced rebleeding after the first 4 minutes of the observation period. |
| Primary | 90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line | 4 minutes post start of treatment application | Hemostasis at the study suture line must be maintained until closure of the surgical wound. Participants were considered treatment failures if they met any of the following conditions: * Did not achieve hemostasis at 4 minutes * Required additional hemostatic treatment other than study treatment during the first 4 minutes of the observation period * Experienced rebleeding after the first 4 minutes of the observation period. |
| Primary | Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding | 4 minutes post start of treatment application | Investigators were shown videos of bleeding severities to standardize assessments. 1. Moderate bleeding defined as: * Either \>25% of the suture line bleeds, or * ≥5 suture line bleedings were present, if counting of suture line bleedings was possible, or * 1 pulsatile suture line bleeding was present. 2. Severe bleeding defined as: * Either \>50% of the suture line bleeds, or * ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or * \>1 pulsatile suture line bleeding was present, or * ≥1 spurting suture line bleeding was present. |
| Primary | Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding | 4 minutes post start of treatment application | Investigators were shown videos of bleeding severities to standardize assessments. Severe bleeding defined as: * Either \>50% of the suture line bleeds, or * ≥10 suture line bleedings were present, if counting of suture line bleedings was possible, or * \>1 pulsatile suture line bleeding was present, or * ≥1 spurting suture line bleeding was present. |
| Secondary | Percentage of Participants Achieving Hemostasis at 6 Minutes | 6 minutes post start of treatment application start | Hemostasis at the study suture line must be maintained until closure of the surgical wound. |
| Secondary | Percentage of Participants Achieving Hemostasis at 10 Minutes | 10 minutes post start of treatment application | Hemostasis at the study suture line must be maintained until closure of the surgical wound. |
| Secondary | Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line | Intraoperative day 0 | Intraoperative rebleeding at the study suture line after occurrence of hemostasis. |
| Secondary | Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line | Postoperative through day 30 ± 5 | Any rebleeding requiring surgical reexploration |
| Secondary | Percentage of Participants With Any Transfusion Requirement | Intraoperative (day 0) through day 30 ± 5 | Proportion of participants who required transfusions (i.e., red blood cell (RBC) concentrates, fresh frozen plasma (FFP), and platelets) |
| Secondary | Percentage of Participants With Graft Occlusions | Day 0 (procedure day) through day 30 ± 5 | Determined clinically and defined as absence of blood flow through the graft. |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 registered outcomesOutcomes27
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | 4 minutes post start of treatment application | Intent to Treat | percentage of participants | NUMBER |
| PRIMARY | 90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line | 4 minutes post start of treatment application | Intent to Treat | percentage of participants | NUMBER |
| PRIMARY | Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding | 4 minutes post start of treatment application | Intent to Treat | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Hemostasis at 6 Minutes | 6 minutes post start of treatment application start | Intent to Treat | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Hemostasis at 10 Minutes | 10 minutes post start of treatment application | Intent to Treat | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line | Intraoperative day 0 | Intent to Treat | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line | Postoperative through day 30 ± 5 | Intent to Treat | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Any Transfusion Requirement | Intraoperative (day 0) through day 30 ± 5 | Intent to Treat | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Graft Occlusions | Day 0 (procedure day) through day 30 ± 5 | Safety Analysis Set | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Infections at the Surgical Site | Day 0 (procedure day) through day 30 ± 5 | Safety Analysis Set | percentage of participants | NUMBER |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 outcomesResults by group237
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | FS VH S/D 500 S-apr- 60-Seconds | Primary Hemostasis Achieved at 4 Minutes | 46.2 | percentage of participants | |
| Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | FS VH S/D 500 S-apr - 120-Seconds | Primary Hemostasis Achieved at 4 Minutes | 62.5 | percentage of participants | |
| Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | Control Group | Primary Hemostasis Achieved at 4 Minutes | 34.8 | percentage of participants | |
| Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | FS VH S/D 500 S-apr- 60-Seconds | Additional Treatment Required for Hemostasis | 30.8 | percentage of participants | |
| Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | FS VH S/D 500 S-apr - 120-Seconds | Additional Treatment Required for Hemostasis | 25.0 | percentage of participants | |
| Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | Control Group | Additional Treatment Required for Hemostasis | 52.2 | percentage of participants | |
| Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | FS VH S/D 500 S-apr- 60-Seconds | Intraoperative Rebleeding After Primary Hemostasis | 3.8 | percentage of participants | |
| Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | FS VH S/D 500 S-apr - 120-Seconds | Intraoperative Rebleeding After Primary Hemostasis | 0.0 | percentage of participants | |
| Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. | Control Group | Intraoperative Rebleeding After Primary Hemostasis | 4.3 | percentage of participants | |
| 90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line | FS VH S/D 500 S-apr - 60-Seconds | 46.2 | 90% Confidence Interval 30.1 to 62.2 | percentage of participants |
1 to 10 of 237Source ClinicalTrials.gov
See all 237 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | FS VH S/D 500 S-apr - 60 Seconds | 26 | |
| Overall Study | STARTED | FS VH S/D 500 S-apr - 120 Seconds | 24 | |
| Overall Study | STARTED | Control Group | 23 | |
| Overall Study | COMPLETED | FS VH S/D 500 S-apr - 60 Seconds | 26 | |
| Overall Study | COMPLETED | FS VH S/D 500 S-apr - 120 Seconds | 24 | |
| Overall Study | COMPLETED | Control Group | 22 | |
| Overall Study | NOT COMPLETED | FS VH S/D 500 S-apr - 60 Seconds | 0 | |
| Overall Study | NOT COMPLETED | FS VH S/D 500 S-apr - 120 Seconds | 0 | |
| Overall Study | NOT COMPLETED | Control Group | 1 |
Source ClinicalTrials.gov
Adverse events84
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Incision site complication | Injury, poisoning and procedural complications | Fibrin Sealant - 60 Seconds | 2 | 26 | 3 |
| other | Incision site complication | Injury, poisoning and procedural complications | Fibrin Sealant - 120 Seconds | 2 | 24 | 2 |
| other | Incision site complication | Injury, poisoning and procedural complications | Fibrin Sealant All - (60 + 120 Seconds) | 4 | 50 | 5 |
| other | Incision site complication | Injury, poisoning and procedural complications | Control Group | 0 | 23 | 0 |
| other | Incision site oedema | Injury, poisoning and procedural complications | Fibrin Sealant - 60 Seconds | 2 | 26 | 2 |
| other | Incision site oedema | Injury, poisoning and procedural complications | Fibrin Sealant - 120 Seconds | 1 | 24 | 1 |
| other | Incision site oedema | Injury, poisoning and procedural complications | Fibrin Sealant All - (60 + 120 Seconds) | 3 | 50 | 3 |
| other | Incision site oedema | Injury, poisoning and procedural complications | Control Group | 1 | 23 | 1 |
| other | Incision site erythema | Injury, poisoning and procedural complications | Fibrin Sealant - 60 Seconds | 0 | 26 | 0 |
| other | Incision site erythema | Injury, poisoning and procedural complications | Fibrin Sealant - 120 Seconds | 2 | 24 | 2 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fibrin Sealant - 60 Seconds | ||
| Total, all-cause mortality | Fibrin Sealant - 120 Seconds | ||
| Total, all-cause mortality | Fibrin Sealant All - (60 + 120 Seconds) | ||
| Total, all-cause mortality | Control Group | ||
| Total, other adverse events | Fibrin Sealant - 60 Seconds | 4 | 26 |
| Total, other adverse events | Fibrin Sealant - 120 Seconds | 9 | 24 |
| Total, other adverse events | Fibrin Sealant All - (60 + 120 Seconds) | 13 | 50 |
| Total, other adverse events | Control Group | 7 | 23 |
| Total, serious adverse events | Fibrin Sealant - 60 Seconds | 4 | 26 |
| Total, serious adverse events | Fibrin Sealant - 120 Seconds | 4 | 24 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21514114 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00576420
GET https://conductscience.org/api/trials/v1/NCT00576420/registered?page=2