Clinical trial NCT02111655: Improving Arteriovenous Fistula Patency
Official title: Second Generation Surveillance Techniques to Prevent Thrombosis and Increase Assisted Primary Patency in Native Arteriovenous Fistula. A Prospective Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thrombosis
Keywords: Thrombosis
Arteriovenous fistulae
Hemodialysis
Doppler ultrasound
Vascular access blood flow
Surveillance
Lead sponsor: Hospital Infanta Sofia
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Informed consent signature.
* Age between 18 and 95 years old.
* Functioning native AVF.
* Patients with end stage renal disease (ESRD) undergoing hemodialysis program for at least three months.

Exclusion Criteria:

* Coagulopathy or hemoglobinopathy of any cause.
* Hospitalization of any cause in the previous month.
* VA related complications or dysfunction in the previous three months.

Primary outcomes:
measure: Improved primary patency rate in arteriovenous fistulae with the use of doppler ultrasound and transonic dilution method
timeFrame: Up to 3 years follow up
Secondary outcomes:
measure: Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.
timeFrame: Up to 1 year follow up
measure: Evaluate the efficacy and efficiency of second generation methods
timeFrame: Up to 2 years follow up
measure: Reproducibility in Doppler ultrasound technique
timeFrame: Up to 3 years follow up.
measure: Possible influence of different baseline items in the risk of thrombosis of native AVF
timeFrame: Up to 3 years follow up
measure: Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.
timeFrame: Up to 2 years follow up
measure: Evaluate the efficacy and efficiency of second generation methods
timeFrame: Up to 3 years follow up
measure: Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.
timeFrame: Up to 3 years follow up
Other outcomes:
Locations:
city: San Sebastian de Los Reyes
country: Spain
facility: Hospital Universitario Infanta Sofia
state: Madrid
city: Madrid
country: Spain
facility: Centro de Diálisis Los Enebros
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Dialcentro
city: Madrid
country: Spain
facility: Clinica Fuensanta
Study officials:
affiliation: HOSPITAL UNIVERSITARIO INFANTA SOFIA
name: ANTONIO CIRUGEDA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOSPITAL UNIVERSITARIO INFANTA SOFIA
name: SILVIA CALDES, MD
role: STUDY_CHAIR
affiliation: CLINICA FUENSANTA
name: YESIKA AMEZQUITA, MD
role: STUDY_CHAIR
affiliation: HOSPITAL UNIVERSITARIO GREGORIO MARAÑON
name: JUAN MANUEL LOPEZ, PhD
role: STUDY_CHAIR
affiliation: HOSPITAL UNIVERSITARIO GREGORIO MARAÑON
name: SORAYA ABAD, MD
role: STUDY_CHAIR
affiliation: Hospital Infanta Sofia
name: INES ARAGONCILLO, MD
role: STUDY_CHAIR
affiliation: HOSPITAL GREGORIO MARAÑON
name: BORJA QUIROGA, MD
role: STUDY_CHAIR
affiliation: Hospital Infanta Sofia
name: FERNANDO DE ALVARO, PhD
role: STUDY_CHAIR
References:
citation: Aragoncillo I, Abad S, Caldes S, Amezquita Y, Vega A, Cirugeda A, Moratilla C, Ibeas J, Roca-Tey R, Fernandez C, Macias N, Quiroga B, Blanco A, Villaverde M, Ruiz C, Martin B, Ruiz AM, Ampuero J, de Alvaro F, Lopez-Gomez JM. Adding access blood flow surveillance reduces thrombosis and improves arteriovenous fistula patency: a randomized controlled trial. J Vasc Access. 2017 Jul 14;18(4):352-358. doi: 10.5301/jva.5000700. Epub 2017 Apr 20.
citation: Aragoncillo I, Amezquita Y, Caldes S, Abad S, Vega A, Cirugeda A, Moratilla C, Ibeas J, Roca-Tey R, Fernandez C, Quiroga B, Blanco A, Villaverde M, Ruiz C, Martin B, Ruiz AM, Ampuero J, Lopez-Gomez JM, de Alvaro F. The impact of access blood flow surveillance on reduction of thrombosis in native arteriovenous fistula: a randomized clinical trial. J Vasc Access. 2016 Jan-Feb;17(1):13-9. doi: 10.5301/jva.5000461. Epub 2015 Sep 18.