Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft ProsthesesPhase 3NCT00892957

FS VH S/D 500 S-apr in Vascular Surgery

A Phase 3 study testing Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) and Surgical gauze pads in people with Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses, run by Baxter Healthcare Corporation at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to compare safety and efficacy of FS VH S/D 500 s-apr (FS) versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft placement. Read more about this study

Who is it for?: Any age
Conditions the study is for: Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses
What is being tested?: Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr) and Surgical gauze pads
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 176 participants
Where: 22 sitesUnited States
Study dates: Jul 2009to Nov 2010
Phase: Phase 3
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

Preoperative inclusion criteria:
Subjects undergoing vascular surgery (ie, conduit placement with an ePTFE graft), including arterio-arterial bypasses, including:
axillo-femoral
axillo-bifemoral
aorto-bifemoral
ilio-femoral

Show all 16Show fewer

femoro-femoral
ilio-popliteal
femoro-popliteal (including below knee)
femoro-tibial vessel bypass
arterio-venous shunting for dialysis access in the upper or lower extremity
Signed informed consent
Subject is of childbearing potential, presents with a negative serum or urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study.
Subject is willing and able to comply with the requirements of the protocol.
Intraoperative inclusion criterion:
Suture line bleeding eligible for study treatment is present after surgical hemostasis (ie, suturing). (A definition of eligible suture line bleeding is provided in the study protocol.)

Who cannot join

Preoperative exclusion criteria:
Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)
Congenital coagulation disorders
Prior kidney transplantation
Heparin-induced thrombocytopenia
Known hypersensitivity to heparin

Show all 16Show fewer

Known hypersensitivity to aprotinin or other components of the product
Known severe congenital or acquired immunodeficiency (eg, HIV infection or long-term treatment with immunosuppressive drugs (eg, organ transplantation patients)
Prior radiation therapy to the operating field
Severe local inflammation at the operating field
Subject is pregnant or lactating at the time of enrollment
Subject has participated in another clinical study involving an investigational product (IP) or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
Subject has previously participated in this study (Protocol No.: 550801), ie, each subject can only be enrolled once.
Intraoperative Exclusion Criteria:
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, (eg, abandonment of ePTFE graft placement)

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

Study site
Baton Rouge, Louisiana
Study site
Bellevue, Washington
Study site
Birmingham, Alabama
Study site
Buffalo, New York
Study site
Charlottesville, Virginia
Study site
Dayton, Ohio
Study site
Fort Wayne, Indiana
Study site
Fresno, California
Study site
Hackensack, New Jersey
Study site
Jacksonville, Florida
Study site
Lexington, Kentucky
Study site
Melbourne, Florida
Study site
Orange, California
Study site
Pittsburgh, Pennsylvania
Study site
Saginaw, Michigan
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
Seattle, Washington
Study site
Southfield, Michigan
Study site
The Bronx, New York
Study site
Tucson, Arizona
Study site
Washington D.C., District of Columbia

Other trials in United States

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 was to compare safety and efficacy of FS VH S/D 500 s-apr (FS) versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft placement.

Conditions: Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses
Being tested: Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), Surgical gauze pads
Keywords: Vascular Surgery, Arterio-arterial bypasses, Arterio-venous (AV) shunts

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)Biological
Also called Biological two-component fibrin sealant
The actual dose of FS VH S/D 500 s-apr will depend on the length of the suture line and the intensity of bleeding (but shall not exceed 4 mL FS VH S/D 500 s-apr).
Surgical gauze padsOther
Manual compression with surgical gauze pads

Study groups in NCT00892957
Study group	Role	What they receive
FS VH S/D 500 s-apr	Experimental	FS VH S/D 500 s-apr will be applied to the study suture line. Receives: Biological: Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)
Manual compression with surgical gauze pads	Active comparator	Dry gauze pads will be positioned to cover the complete study suture line. Receives: Other: Surgical gauze pads

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.
Hemostasis at the study suture line must be maintained until closure of the surgical wound.
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.
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 Who Achieved Hemostasis at 6 Minutes Post Treatment Application
Hemostasis at the study suture line must be maintained until closure of the surgical wound.
Measured: 6 minutes post start of treatment application
Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application
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 Study Suture Line
Intraoperative rebleeding at the study suture line after occurrence of hemostasis.
Measured: Intraoperative day 0
Percentage of Participants With Postoperative Rebleeding
Any rebleeding requiring surgical re-exploration
Measured: Postoperative through day 30 ± 5
Percentage of Participants With Graft Occlusion
Determined clinically and defined as absence of blood flow through the graft.
Measured: post-op discharge/day 1, post-op day 14 and day 30
Percentage of Participants With Infection at the Surgical Site
Measured: post-op discharge/day 1, post-op day 14 and day 30
Number of Participants With Infections by Grade
Infections were recorded according to:
- Grade I: only dermis affected
- Grade II: infection invades subcutaneous region but not the arterial implant
- Grade III: the arterial implant is infected
Measured: post-op discharge/day 1, post-op day 14 and day 30
Vital Signs: Systolic and Diastolic Blood Pressure (BP)- 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: Within 14 days prior to surgery 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: Within 14 days prior to surgery 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 Heart Rate Measured as: Preoperative Baseline - Postoperative Day 1; and Preoperative Baseline - Postoperative Day 14
Measured: Within 14 days prior to surgery 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.

Jul 2009Nov 2010

First posted5 May 2009 (estimated)
Study startJul 2009
Primary completionOct 2010
Study completionNov 2010

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 Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft ProsthesesStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00892957
Sponsor's protocol ID: 550801
Status last verified: Oct 2012
First submitted: 4 May 2009
Last updated: 27 Nov 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Saha SP, Muluk S, Schenk W 3rd, Dennis JW, Ploder B, Grigorian A, Presch I, Goppelt A. A prospective randomized study comparing fibrin sealant to manual compression for the treatment of anastomotic suture-hole bleeding in expanded polytetrafluoroethylene grafts. J Vasc Surg. 2012 Jul;56(1):134-41. doi: 10.1016/j.jvs.2012.01.009. Epub 2012 May 25.
PubMed 22633423

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: NCT00892957
Acronym / sponsor ID: 550801
Conditions: Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses
Keywords: Vascular Surgery, Arterio-arterial bypasses, Arterio-venous (AV) shunts
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 176 participants (actual)
Lead sponsor: Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
Study start: Jul 2009
Primary completion: Oct 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 5 May 2009 (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 was to compare safety and efficacy of FS VH S/D 500 s-apr (FS) versus manual compression in prosthetic expanded polytetrafluoroethylene (ePTFE) graft placement.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
FS VH S/D 500 s-apr	Experimental	Biological: Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)FS VH S/D 500 s-apr will be applied to the study suture line.
Manual compression with surgical gauze pads	Active comparator	Other: Surgical gauze padsDry gauze pads will be positioned to cover the complete study suture line.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (16 listed)

Subjects undergoing vascular surgery (ie, conduit placement with an ePTFE graft), including arterio-arterial bypasses, including:
Signed informed consent
Subject is of childbearing potential, presents with a negative serum or urine pregnancy test, and agrees to employ adequate birth control measures for the duration of the study.
Subject is willing and able to comply with the requirements of the protocol.
Suture line bleeding eligible for study treatment is present after surgical hemostasis (ie, suturing). (A definition of eligible suture line bleeding is provided in the study protocol.)

Key exclusion criteria (16 listed)

Other vascular procedures during the same surgical session (stenting and/or endarterectomy of the same artery are allowed)
Congenital coagulation disorders
Prior kidney transplantation
Heparin-induced thrombocytopenia
Known hypersensitivity to heparin

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
Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr)Also: Biological two-component fibrin sealantThe actual dose of FS VH S/D 500 s-apr will depend on the length of the suture line and the intensity of bleeding (but shall not exceed 4 mL FS VH S/D 500 s-apr).	Biological	FS VH S/D 500 s-apr
Surgical gauze padsManual compression with surgical gauze pads	Other	Manual compression with surgical gauze pads

Primary outcome

Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.
Time frame: 4 minutes post start of treatment application
Hemostasis at the study suture line must be maintained until closure of the surgical wound.
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. 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.
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 Who Achieved Hemostasis at 6 Minutes Post Treatment Application
Time frame: 6 minutes post start of treatment application
Percentage of Participants Who Achieved Hemostasis at 10 Minutes Post Treatment Application
Time frame: 10 minutes post start of treatment application
Percentage of Participants With Intraoperative Rebleeding After Hemostasis at Study Suture Line
Time frame: Intraoperative day 0
Percentage of Participants With Postoperative Rebleeding
Time frame: Postoperative through day 30 ± 5
Percentage of Participants With Graft Occlusion
Time frame: post-op discharge/day 1, post-op day 14 and day 30
Percentage of Participants With Infection at the Surgical Site
Time frame: post-op discharge/day 1, post-op day 14 and day 30
Number of Participants With Infections by Grade
Time frame: post-op discharge/day 1, post-op day 14 and day 30
Vital Signs: Systolic and Diastolic Blood Pressure (BP)- Preoperative Baseline
Time frame: Within 14 days prior to date of surgery
Percent Change in Vital Signs: Systolic and Diastolic Blood Pressure
Time frame: Within 14 days prior to surgery 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: Within 14 days prior to surgery 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: Within 14 days prior to surgery 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

Results posted to the registry on 27 Nov 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
FS VH S/D 500 S-apr	70	70
Control - Manual Compression With Surgical Gauze Pads	70	70

Primary outcome: Percentage of Participants Who Achieved Hemostasis at 4 Minutes Post Treatment Application.

Time frame: 4 minutes post start of treatment application. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	FS VH S/D 500 S-apr n = 70	Control - Manual Compression With Surgical Gauze n = 70
Value	62.9 (51.2 to 73.6)	31.4 (21.4 to 42.8)

FS VH S/D 500 S-apr vs Control - Manual Compression With Surgical Gauze: p <0.0001, Likelihood ratio chi-square test

Population analysed: Intent to Treat

Primary outcome: 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. Number (95% Confidence Interval). Unit: percentage of participants

Measure	FS VH S/D 500 S-apr n = 29	Control - Manual Compression With Surgical Gauze n = 27
Value	75.9 (58.5 to 88.8)	48.1 (30.1 to 66.5)

Population analysed: Intent to Treat

Primary outcome: 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. Number (95% Confidence Interval). Unit: percentage of participants

Measure	FS VH S/D 500 S-apr n = 41	Control - Manual Compression With Surgical Gauze n = 42
Value	53.7 (38.5 to 68.4)	20.9 (10.7 to 34.6)

Population analysed: Intent to Treat

23 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the study period, 1 year and 3 months. For SAEs: Recovering/resolving SAEs were followed until resolution, medically stabilized, or 30 days after study completion/termination visit, whichever came first.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
FS VH S/D 500 S-apr	20 of 70 (28.6%)	14 of 70 (20%)	Not reported
Control - Manual Compression With Surgical Gauze Pads	18 of 70 (25.7%)	7 of 70 (10%)	Not reported

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.
Background: PubMed 22633423Saha SP, Muluk S, Schenk W 3rd, Dennis JW, Ploder B, Grigorian A, Presch I, Goppelt A. A prospective randomized study comparing fibrin sealant to manual compression for the treatment of anastomotic suture-hole bleeding in expanded polytetrafluoroethylene grafts. J Vasc Surg. 2012 Jul;56(1):134-41. doi: 10.1016/j.jvs.2012.01.009. Epub 2012 May 25.

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.

Isabella Presch, MD, MBA study director

Baxter Innovations GmbH

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 inclusion and 16 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 22 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Who Achieved Hemostasis at 4 Minutes Post Treatment Application. (time frame: 4 minutes post start of treatment application). The study lists 3 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 NCT00892957, 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.