|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00439309 |
|
Date of registration:
|
21/02/2007 |
|
Primary sponsor: |
|
|
Public title:
|
Study to Evaluate Safety & Effectiveness of Vascular Sealant System
|
|
Scientific title:
|
Randomized Study to Evaluate Safety & Effectiveness of Vascular Sealant to Control Suture Line Bleeding |
|
Date of first enrolment:
|
April 2007 |
|
Target sample size:
|
69 |
|
Recruitment status: |
Terminated |
|
URL:
|
http://clinicaltrials.gov/show/NCT00439309 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Vladimir I Scerbin |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Confluent Surgical |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
Subject was > 18 years of age. Scheduled for elective vascular surgery that entails
placement of a PTFE vascular graft including extra-anatomic, infrainguinal bypass, and
primary and secondary arteriovenous access procedures. Subject was willing and able to
comply with all aspects of the treatment and evaluation schedule. Informed of the nature
of the study, and has provided written informed consent, approved by the appropriate
Institutional Review Board (IRB) of the respective clinical site
Exclusion Criteria:
Subject had a known local or systemic infection. Subjects with known coagulopathies
including hemophilia, factor deficiencies, platelet count < 80,000 u/mL, heparin induced
thrombocytopenia or uncorrected INR > 1.5. Subject was participating in a clinical trial
that requires treatment with another investigational device or drug. Subject was
lactating or pregnant, or does not agree to use contraception for the duration of the
study. Subject had a known hypersensitivity to any components of bovine thrombin
preparations and/or material of bovine origin. The investigator determined that the
subject should not be included in the study for reason(s) not already specified
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Peripheral Vascular Disease
|
|
Intervention(s)
|
|
Device: Gelfoam/Thrombin
|
|
Device: VascuSeal
|
|
Primary Outcome(s)
|
|
The primary effectiveness endpoint is sealing success defined as complete anastomotic suture line sealing within 10 minutes following restoration of blood flow without use of an adjunctive hemostatic technique different from the assigned treatment.
[Time Frame: intra-operative]
|
|
Secondary Outcome(s)
|
|
At each site, time to hemostasis was determined from the time circulation was restored after treatment application until bleeding had stopped (assessed at intervals of 1, 3, 5, 7.5 and 10 minutes).
[Time Frame: intra-operative]
|
|
The proportion of immediate sealing successes at treated anastomoses by treatment group, with immediate sealing success defined as a site with no suture line bleeding after blood flow is restored
[Time Frame: intra-operative]
|
|
The proportion of overall sealing successes (within 10 minutes) at treated anastomoses in each treatment group.
[Time Frame: intra-operative]
|
|
Time to wound closure was determined, with wound closure defined as the elapsed time between initial clamp removal at the last anastomotic site until skin closure.
[Time Frame: intra-operative]
|
|
Secondary ID(s)
|
|
VAS-06-001
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|