Thrombosis Clinical Trial
Official title:
Second Generation Surveillance Techniques to Prevent Thrombosis and Increase Assisted Primary Patency in Native Arteriovenous Fistula. A Prospective Controlled Trial.
All vascular access guidelines recommend monitoring and surveillance protocols to prevent
vascular access complications in hemodialysis units.
However, in the case of second generation screening techniques which determine access blood
flow measurement (QA), there is a huge controversy about it´s efficiency.
Although multiple observational studies find a decrease in the thrombosis rate and an
increased primary assisted patency survival related to the use of these techniques, a
recently published meta-analysis find contradictory results in the randomized controlled
trials, affirming that the measurement of QA is useless in grafts and questionable in native
arteriovenous fistulae (AVF).
We have designed a multicenter, prospective, open label, controlled, randomized trial, to
prove the usefulness of the QA measurement using two complementary second generation
techniques, Doppler ultrasound and Transonic dilution method, compared to the classical
monitoring and surveillance methods.
The primary endpoint will be a reduction in the thrombosis rate with an increased assisted
primary patency survival, and a cost effectiveness economic analysis.
As secondary endpoints we will analyze the impact over non-assisted primary patency survival
and secondary patency survival.
Definition:
Multicenter, prospective, open label, controlled, randomized trial, to prove the usefulness
of the QA measurement using two complementary second generation techniques, Doppler
ultrasound and Transonic dilution method, compared to the classical monitoring and
surveillance methods.
For Patient Registries:
Clinical data repository (CDR) paper notebook will contain all baseline patient
characteristics and the information related to vascular access. These data will be collected
by the different investigators and reviewed and included in data base by the study´s
monitor.
This information will be included in a centralized computer database (SPSS 15.0 computer
system) and encoded in order to preserve patients´ confidentiality.
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