Clinical Trial: Second Generation Surveillance Methods To Prevent Thrombosis And Increase Assisted Primary Patency Survival In Native Arteriovenous Fistulae

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: SECOND GENERATION SURVEILLANCE TECHNIQUES (METHODS) TO PREVENT THROMBOSIS AND INCREASE ASSISTED PRIMARY PATENCY SURVIVAL IN NATIVE ARTERIOVENOUS FISTULAE. A PROSPECTIVE CO

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 Summary:

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.


Sponsor: Hospital Infanta Sofia

Current Primary Outcome:

  • Improved primary patency rate in arteriovenous fistulae with the use of doppler ultrasound and transonic dilution method [ Time Frame: Up to 1 year follow up ]

    Differences in assisted primary patency rates (thrombosis free access survival) in AVF between the two groups: control group in which classical monitoring and surveillance techniques are applied and experimental group in which Doppler ultrasound and transonic were performed every three months in addition to classical methods.

    Cost efficacy analysis in both groups will be done, measuring all vascular access (VA) related health care spending (VA hospitalization costs, central venous catheter (CVC) placements, surgeries and endovascular procedures will be recorded).

  • Improved primary patency rate in arteriovenous fistulae with the use of doppler ultrasound and transonic dilution method [ Time Frame: Up to 2 years follow up ]

    Differences in assisted primary patency rates (thrombosis free access survival) in AVF between the two groups: control group in which classical monitoring and surveillance techniques are applied and experimental group in which Doppler ultrasound and transonic were performed every three months in addition to classical methods.

    Cost efficacy analysis in both groups will be done, measuring all vascular access (VA) related health care spending (VA hospitalization costs, central venous catheter (CVC) placements, surgeries and endovascular procedures will be recorded).

  • Improved primary patency rate in arteriovenous fistulae w

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups. [ Time Frame: Up to 1 year follow up ]
    • Evaluate the efficacy and efficiency of second generation methods [ Time Frame: Up to 2 years follow up ]
      It will be evaluated the positive and negative predictive value of each second generation technique, doppler ultrasound and Transonic dilution method. The accuracy of these techniques will be compared to determine which one show more benefits detecting pathology of AVF.
    • Reproducibility in Doppler ultrasound technique [ Time Frame: Up to 3 years follow up. ]
      There will be always two observers for each doppler ultrasound (same observers for same AVF). Differences among different quarterly measures in stable AVF will be evaluated, as well as the differences between the two observers in QA measurement.
    • Possible influence of different baseline items in the risk of thrombosis of native AVF [ Time Frame: Up to 3 years follow up ]
      It will be evaluated if there is any influence of age, body mass index, use of antiplatelet therapy, anticoagulant therapy and the use of pentoxifylline in the risk of thrombosis of AVF
    • Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups. [ Time Frame: Up to 2 years follow up ]
    • Evaluate the efficacy and efficiency of second generation methods [ Time Frame: Up to 3 years follow up ]
      It will be evaluated the positive and negative predictive value of each second generation technique, doppler ultrasound and Transonic dilution method. The accuracy of these techniques will be compared to determine which one show more benefits detecting pathology of AVF.
    • Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups. [ Time Frame: Up to 3 years follow up ]


    Original Secondary Outcome: Same as current

    Information By: Hospital Infanta Sofia

    Dates:
    Date Received: March 28, 2014
    Date Started: September 2012
    Date Completion:
    Last Updated: August 11, 2014
    Last Verified: August 2014