Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)Phase 2NCT00576420
Fibrin Sealant Vascular Surgery Study
A Phase 2 study testing FS VH S/D 500 s-apr, 60-seconds polymerization time, FS VH S/D 500 s-apr, 120-seconds polymerization time and Manual compression with surgical gauze pads in people with Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts), run by Baxter Healthcare Corporation at 11 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) for hemostasis in participants receiving prosthetic expanded polytetrafluoroethylene (ePTFE) conduits as compared to a… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)
- What is being tested?
- FS VH S/D 500 s-apr, 60-seconds polymerization time, FS VH S/D 500 s-apr, 120-seconds polymerization time and Manual compression with surgical gauze pads
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 11 sitesUnited States
- Study dates
- Dec 2007to Dec 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female of all ages
- Subject undergoing peripheral vascular surgery, ie, conduit placement with an ePTFE graft such as arterio-arterial bypasses [including: axillo-femoral, ilio-femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass], or arteriovenous dialysis access shunt in the upper or lower extremity.
- Signed informed consent
- Intraoperative inclusion criterion:
- Suture line bleeding eligible for study treatment is present after surgical hemostasis (i.e., suturing).
- Suture line bleeding eligible for study treatment is defined as: any suture line bleeding that would prevent immediate closure of the wound and require treatment of the bleeding first, and on a scale of mild, moderate, and severe, the suture line bleeding is assessed as moderate or severe. (Moderate is defined as: either more than 25% of the suture line bleeds, or at least 5 suture line bleedings are present, if counting of suture line bleedings is possible, or one pulsatile suture line bleeding is present. Severe is defined as: either more than 50% of the suture line bleeds, or at least 10 suture line bleedings present, if counting of suture line bleedings is possible, or more than one pulsatile suture line bleedings are present, or at least one spurting suture line bleeding is present.)
- Note: Bleedings that can be treated with additional sutures are not appropriate for the study. Such anastomoses should receive additional sutures, be re-categorized, and if they still comply with the inclusion criteria, be randomized.
Who cannot join
- Subjects concurrently participating in another clinical study treatment with another investigational drug or device within the last 30 days
- Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)
- Arterio-arterial bypasses with more than 2 anastomoses (e.g., aorto-bifemoral, axillo-bifemoral etc.)
- Pregnant or lactating women
- Congenital coagulation disorders
- Prior kidney transplantation
Show all 15Show fewer
- Heparin-induced thrombocytopenia
- Known prior exposure to aprotinin within the last 12 months
- Known hypersensitivity to aprotinin or other components of the product
- Known severe congenital or acquired immunodeficiency (e.g., HIV infection or long term treatment with immunosuppressive drugs)
- Prior radiation therapy to the operating field
- Severe local inflammation at the operating field.
- Intraoperative exclusion criterion:
- Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
- Intraoperative change in planned surgical procedure, which results in subject no longer meeting preoperative inclusion and/or exclusion criteria, (e.g. abandonment of ePTFE graft placement).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Baton Rouge, Louisiana
Study site
Birmingham, Alabama
Study site
Charlottesville, Virginia
Study site
Jacksonville, Florida
Study site
Lexington, Kentucky
Study site
Long Beach, California
Study site
Pittsburgh, Pennsylvania
Study site
Salt Lake City, Utah
Study site
Seattle, Washington
Study site
Tucson, Arizona
Study site
Virginia Beach, Virginia
About this study
Official title: Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 S-apr for Hemostasis in Subjects Undergoing Vascular Surgery
The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) for hemostasis in participants receiving prosthetic expanded polytetrafluoroethylene (ePTFE) conduits as compared to a control group treated by manual compression with surgical gauze pads.
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FS VH S/D 500 s-apr, 60-seconds polymerization timeBiological
FS VH S/D 500 s-apr (FS) is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr.
FS VH S/D 500 s-apr, 120-seconds polymerization timeBiological
Treatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps.
Manual compression with surgical gauze padsProcedure or surgery
Treatment of the study suture line with manual compression with surgical gauze pads.
| Study group | Role | What they receive |
|---|---|---|
| FS VH S/D 500 s-apr - 60-Seconds | Experimental | Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) will be applied to the study suture line, 60-second polymerization time Receives: Biological: FS VH S/D 500 s-apr, 60-seconds polymerization time |
| FS VH S/D 500 s-apr - 120-Seconds | Experimental | FS VH S/D 500 s-apr will be applied to the study suture line, 120-second polymerization time Receives: Biological: FS VH S/D 500 s-apr, 120-seconds polymerization time |
| Control Group- Manual compression with surgical gauze pads | Active comparator | Treatment of the study-suture line will be manual compression with surgical gauze pads. Receives: Procedure: Manual compression with surgical gauze pads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.
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.
Measured: 4 minutes post start of treatment application
90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line
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.
Measured: 4 minutes post start of treatment application
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding
Investigators were shown videos of bleeding severities to standardize assessments.
- 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.
- 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.
Measured: 4 minutes post start of treatment application
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding
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.
Measured: 4 minutes post start of treatment application
Secondary outcomes (23)
Percentage of Participants Achieving Hemostasis at 6 Minutes
Hemostasis at the study suture line must be maintained until closure of the surgical wound.
Measured: 6 minutes post start of treatment application start
Percentage of Participants Achieving Hemostasis at 10 Minutes
Hemostasis at the study suture line must be maintained until closure of the surgical wound.
Measured: 10 minutes post start of treatment application
Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line
Intraoperative rebleeding at the study suture line after occurrence of hemostasis.
Measured: Intraoperative day 0
Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line
Any rebleeding requiring surgical reexploration
Measured: Postoperative through day 30 ± 5
Percentage of Participants With Any Transfusion Requirement
Proportion of participants who required transfusions (i.e., red blood cell (RBC) concentrates, fresh frozen plasma (FFP), and platelets)
Measured: Intraoperative (day 0) through day 30 ± 5
Percentage of Participants With Graft Occlusions
Determined clinically and defined as absence of blood flow through the graft.
Measured: Day 0 (procedure day) through day 30 ± 5
Percentage of Participants With Infections at the Surgical Site
Measured: Day 0 (procedure day) through day 30 ± 5
Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline
Measured: Within 14 days prior to date of surgery
Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure
Percent Change in Systolic and Diastolic Blood Pressure (BP) Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14
Measured: Preoperative baseline through postoperative Day 14
Vital Signs: Heart Rate - Preoperative Baseline
Measured: Within 14 days prior to date of surgery
Percent Change in Vital Signs: Heart Rate
Percent Change in Heart Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14
Measured: Preoperative baseline through postoperative Day 14
Vital Signs: Respiratory Rate - Preoperative Baseline
Measured: Within 14 days prior to date of surgery
Percent Change in Vital Signs: Respiratory Rate
Percent Change in Respiratory Rate Measured as: Preoperative Baseline - Intraoperative Day 0; Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14
Measured: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Hemoglobin
Measured: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Hematocrit
Measured: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Erythrocytes
Measured: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes
Measured: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Platelets
Measured: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)
Measured: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Alanine Aminotransferase (ALT)
Measured: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Aspartate Aminotransferase (AST)
Measured: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)
Measured: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: International Normalized Ratio (INR)
Measured: Preoperative baseline through postoperative Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00576420
- Sponsor's protocol ID
- 550602
- Status last verified
- Oct 2012
- First submitted
- 18 Dec 2007
- Last updated
- 27 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Saha SP, Muluk S, Schenk W 3rd, Burks SG, Grigorian A, Ploder B, Presch I, Pavlova BG, Hantak E. Use of fibrin sealant as a hemostatic agent in expanded polytetrafluoroethylene graft placement surgery. Ann Vasc Surg. 2011 Aug;25(6):813-22. doi: 10.1016/j.avsg.2010.12.016. Epub 2011 Apr 21.
PubMed 21514114
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Efficacy and Safety of FS VH S/D 500 S-apr for Hemostasis in Subjects Undergoing Vascular Surgery
- ClinicalTrials.gov ID
- NCT00576420
- Acronym / sponsor ID
- 550602
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 19 Dec 2007 (estimated)
- Results
- Posted 27 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) for hemostasis in participants receiving prosthetic expanded polytetrafluoroethylene (ePTFE) conduits as compared to a control group treated by manual compression with surgical gauze pads.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FS VH S/D 500 s-apr - 60-Seconds | Experimental | Biological: FS VH S/D 500 s-apr, 60-seconds polymerization timeFibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) will be applied to the study suture line, 60-second polymerization time |
| FS VH S/D 500 s-apr - 120-Seconds | Experimental | Biological: FS VH S/D 500 s-apr, 120-seconds polymerization timeFS VH S/D 500 s-apr will be applied to the study suture line, 120-second polymerization time |
| Control Group- Manual compression with surgical gauze pads | Active comparator | Procedure: Manual compression with surgical gauze padsTreatment of the study-suture line will be manual compression with surgical gauze pads. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female of all ages
- Subject undergoing peripheral vascular surgery, ie, conduit placement with an ePTFE graft such as arterio-arterial bypasses [including: axillo-femoral, ilio-femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass], or arteriovenous dialysis access shunt in the upper or lower extremity.
- Signed informed consent
- Suture line bleeding eligible for study treatment is present after surgical hemostasis (i.e., suturing).
- Suture line bleeding eligible for study treatment is defined as: any suture line bleeding that would prevent immediate closure of the wound and require treatment of the bleeding first, and on a scale of mild, moderate, and severe, the suture line bleeding is assessed as moderate or severe. (Moderate is defined as: either more than 25% of the suture line bleeds, or at least 5 suture line bleedings are present, if counting of suture line bleedings is possible, or one pulsatile suture line bleeding is present. Severe is defined as: either more than 50% of the suture line bleeds, or at least 10 suture line bleedings present, if counting of suture line bleedings is possible, or more than one pulsatile suture line bleedings are present, or at least one spurting suture line bleeding is present.)
Key exclusion criteria (15 listed)
- Subjects concurrently participating in another clinical study treatment with another investigational drug or device within the last 30 days
- Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)
- Arterio-arterial bypasses with more than 2 anastomoses (e.g., aorto-bifemoral, axillo-bifemoral etc.)
- Pregnant or lactating women
- Congenital coagulation disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FS VH S/D 500 s-apr, 60-seconds polymerization timeFS VH S/D 500 s-apr (FS) is applied to the study suture line. The actual dose of FS VH S/D 500 s-apr depends on the length of the suture line and the intensity of bleeding and is to be decided by the surgeon, but the maximum dose per suture line shall not exceed 4 mL FS VH S/D 500 s apr. After application of FS VH S/D 500 s-apr to the study suture line is completed, the surgeon will wait for 1 minute to allow polymerization of FS VH S/D 500 s-apr. | Biological | FS VH S/D 500 s-apr - 60-Seconds |
| FS VH S/D 500 s-apr, 120-seconds polymerization timeTreatment will be identical to the FS VH S/D 500 s-apr Group, 60 seconds polymerization time, except that the surgeons will wait 2 minutes to allow polymerization and will then open the cross clamps. | Biological | FS VH S/D 500 s-apr - 120-Seconds |
| Manual compression with surgical gauze padsTreatment of the study suture line with manual compression with surgical gauze pads. | Procedure or surgery | Control Group- Manual compression with surgical gauze pads |
Primary outcome
Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line.
Time frame: 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.
90% Confidence Interval for the Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Suture Line
Time frame: 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.
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Moderate Bleeding
Time frame: 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.
Hemostasis at 4 Minutes After Treatment Application at the Suture Line by Bleeding Severity - Severe Bleeding
Time frame: 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.
23 secondary outcomes
Percentage of Participants Achieving Hemostasis at 6 Minutes
Time frame: 6 minutes post start of treatment application start
Percentage of Participants Achieving Hemostasis at 10 Minutes
Time frame: 10 minutes post start of treatment application
Percentage of Participants With Intraoperative Rebleeding After Hemostasis at the Study Suture Line
Time frame: Intraoperative day 0
Percentage of Participants With Postoperative Rebleeding After Hemostasis at the Study Suture Line
Time frame: Postoperative through day 30 ± 5
Percentage of Participants With Any Transfusion Requirement
Time frame: Intraoperative (day 0) through day 30 ± 5
Percentage of Participants With Graft Occlusions
Time frame: Day 0 (procedure day) through day 30 ± 5
Percentage of Participants With Infections at the Surgical Site
Time frame: Day 0 (procedure day) through day 30 ± 5
Vital Signs: Systolic and Diastolic Blood Pressure - Preoperative Baseline
Time frame: Within 14 days prior to date of surgery
Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure
Time frame: Preoperative baseline through postoperative Day 14
Vital Signs: Heart Rate - Preoperative Baseline
Time frame: Within 14 days prior to date of surgery
Percent Change in Vital Signs: Heart Rate
Time frame: Preoperative baseline through postoperative Day 14
Vital Signs: Respiratory Rate - Preoperative Baseline
Time frame: Within 14 days prior to date of surgery
Percent Change in Vital Signs: Respiratory Rate
Time frame: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Hemoglobin
Time frame: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Hematocrit
Time frame: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Erythrocytes
Time frame: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Leukocytes, Basophils, Eosinophils, Lymphocytes, Neutrophils, and Monocytes
Time frame: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Platelets
Time frame: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Creatinine, Bilirubin, and Blood Urea Nitrogen (BUN)
Time frame: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Alanine Aminotransferase (ALT)
Time frame: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Aspartate Aminotransferase (AST)
Time frame: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: Activated Partial Thromboplastin Time (aPTT)
Time frame: Preoperative baseline through postoperative Day 14
Laboratory Values Over Time: International Normalized Ratio (INR)
Time frame: Preoperative baseline through postoperative Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21514114Saha SP, Muluk S, Schenk W 3rd, Burks SG, Grigorian A, Ploder B, Presch I, Pavlova BG, Hantak E. Use of fibrin sealant as a hemostatic agent in expanded polytetrafluoroethylene graft placement surgery. Ann Vasc Surg. 2011 Aug;25(6):813-22. doi: 10.1016/j.avsg.2010.12.016. Epub 2011 Apr 21.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FS VH S/D 500 s-apr, 60-seconds polymerization time, FS VH S/D 500 s-apr, 120-seconds polymerization time and Manual compression with surgical gauze pads in people with Adjunct to Hemostasis in Vascular Surgery (Synthetic Vascular Grafts), run by Baxter Healthcare Corporation at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Hemostasis at 4 Minutes After Treatment Application at the Study Suture Line. (time frame: 4 minutes post start of treatment application). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00576420, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2012.