ThrombosisMETTRONCT02111655
Improving Arteriovenous Fistula Patency
A study testing Second generation surveillance of AVF, vital signs and physical examination of AVF in people with Thrombosis, run by Hospital Infanta Sofia at 5 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Thrombosis
- What is being tested?
- Second generation surveillance of AVF, vital signs and physical examination of AVF
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 5 sitesSpain
- Study dates
- 1 Sep 2012to 29 Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Coagulopathy or hemoglobinopathy of any cause.
- Hospitalization of any cause in the previous month.
- VA related complications or dysfunction in the previous three months.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Centro de Diálisis Los Enebros
Madrid, 28007
Hospital Universitario Gregorio Marañon
Madrid, 28007
Dialcentro
Madrid, 28009
Clinica Fuensanta
Madrid, 28027
Hospital Universitario Infanta Sofia
San Sebastián de los Reyes, Madrid, 28702
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Thrombosis
- Being tested
- Second generation surveillance of AVF, vital signs, physical examination of AVF, ktv test, urea method
- Keywords
- Thrombosis, Arteriovenous fistulae, Hemodialysis, Doppler ultrasound, Vascular access blood flow, Surveillance
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Second generation surveillance of AVFDevice
Also called Doppler ultrasound: M-Turbo. Sonosite., Transonic dilution method: Transonic System Inc HD-03
Doppler ultrasound and transonic dilution method technique will be performed in the experimental group quarterly.
QA will be measured by both techniques and haemodynamic repercussion stenosis will be evaluated by doppler ultrasound.
vital signsProcedure or surgery
Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session
physical examination of AVFProcedure or surgery
Predialysis physical examination of AVF every dialysis session.
ktv testProcedure or surgery
Weekly ktv measurement using biosensors. In patients who have been dialyzed in monitors with no biosensors, ktv will be measured monthly using monocompartimental Daugirdas equation
urea methodProcedure or surgery
Quarterly recirculation with urea method.
| Study group | Role | What they receive |
|---|---|---|
| Clasical Surveillance of AVF | Other | Classical evaluation of AVF includes:
1. Vital sings and predialysis physical examination of AVF every dialysis session.
2. Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session.
3. Weekly ktv test using biosensors or monthly if using monocompartimental Daugirdas equation.
4. Quarterly recirculation with urea method.
Following Spanish Nephrology VA guidelines will be consider as alarm criteria:
1.25% Increased venous pressure. 2.25% Decreased pump blood flow. 3.0,2 ktv decreased compared with previous measurement. 4.> 10% recirculation using urea method. 5.Prolonged coagulation time or cannulation difficulties in 3 consecutive dialysis sessions.
6.Pathologic physical examination with any other criteria. Receives: Procedure: vital signs; Procedure: physical examination of AVF; Procedure: ktv test; Procedure: urea method |
| Second generation surveillance of AVF | Experimental | In addition to the classical surveillance and monitoring methods, in the experimental group Doppler ultrasound and transonic dilution method will be performed on a quarterly basis.
In addition to the classical alarm criteria and derived from the results in Doppler ultrasound an transonic dilution method the following alarm criteria would also be considered in the experimental group:
1. 25% or higher decreased in QA compared with previous measurement.
2. QA lower than 500 ml/min.
3. Stenotic area with a higher than 50% reduction of blood vessel lumen would be considered as alarm criteria only if it comes with a haemodynamic repercussion criteria defined as Peak systolic velocity (PSV) higher than 400 cm/sc, aliasing, or PSV ratio stenosis/pre-stenosis higher than 3. Receives: Device: Second generation surveillance of AVF; Procedure: vital signs; Procedure: physical examination of AVF; Procedure: ktv test; Procedure: urea method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved primary patency rate in arteriovenous fistulae with the use of doppler ultrasound and transonic dilution method
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).
Measured: Up to 3 years follow up
Secondary outcomes (7)
Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.
Measured: Up to 1 year follow up
Evaluate the efficacy and efficiency of second generation methods
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.
Measured: Up to 2 years follow up
Reproducibility in Doppler ultrasound technique
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.
Measured: Up to 3 years follow up.
Possible influence of different baseline items in the risk of thrombosis of native AVF
It will be evaluated if there is any influence of age, body mass index, use of antiplatelet therapy, anticoagulant therapy or the use of pentoxifylline in the risk of thrombosis of AVF
Measured: Up to 3 years follow up
Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.
Measured: Up to 2 years follow up
Evaluate the efficacy and efficiency of second generation methods
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.
Measured: Up to 3 years follow up
Compared non-assisted primary patency rates (intervention free access survival) and secondary patency rates (access survival until abandonment) between the two groups.
Measured: Up to 3 years follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2014 (estimated)
- Study start1 Sep 2012
- Primary completion29 Sep 2015
- Study completion29 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ThrombosisStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Infanta Sofia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Cirugeda, Hospital Infanta Sofia
- Investigators
- ANTONIO CIRUGEDA, MD, Principal investigator, HOSPITAL UNIVERSITARIO INFANTA SOFIASILVIA CALDES, MD, Study chair, HOSPITAL UNIVERSITARIO INFANTA SOFIAYESIKA AMEZQUITA, MD, Study chair, CLINICA FUENSANTAJUAN MANUEL LOPEZ, PhD, Study chair, HOSPITAL UNIVERSITARIO GREGORIO MARAÑONSORAYA ABAD, MD, Study chair, HOSPITAL UNIVERSITARIO GREGORIO MARAÑONINES ARAGONCILLO, MD, Study chair, Hospital Infanta SofiaBORJA QUIROGA, MD, Study chair, HOSPITAL GREGORIO MARAÑONFERNANDO DE ALVARO, PhD, Study chair, Hospital Infanta Sofia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02111655
- Sponsor's protocol ID
- 210443-031132-261233
- Other IDs
- 3598
- Acronym
- METTRO
- Status last verified
- Jun 2017
- First submitted
- 28 Mar 2014
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28430315Aragoncillo 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.
PubMed 26391583
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Second Generation Surveillance Techniques to Prevent Thrombosis and Increase Assisted Primary Patency in Native Arteriovenous Fistula. A Prospective Controlled Trial.
- ClinicalTrials.gov ID
- NCT02111655
- Acronym / sponsor ID
- METTRO / 210443-031132-261233
- Conditions
- Thrombosis
- Keywords
- Thrombosis, Arteriovenous fistulae, Hemodialysis, Doppler ultrasound, Vascular access blood flow, Surveillance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Hospital Infanta SofiaUniversity, hospital or other
- Study start
- 1 Sep 2012
- Primary completion
- 29 Sep 2015 (actual)
- Study completion
- 29 Sep 2015 (actual)
- First posted
- 11 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clasical Surveillance of AVF | Other | Procedure: vital signs, Procedure: physical examination of AVF, Procedure: ktv test, Procedure: urea methodClassical evaluation of AVF includes: 1. Vital sings and predialysis physical examination of AVF every dialysis session. 2. Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session. 3. Weekly ktv test using biosensors or monthly if using monocompartimental Daugirdas equation. 4. Quarterly recirculation with urea method. Following Spanish Nephrology VA guidelines will be consider as alarm criteria: 1.25% Increased venous pressure. 2.25% Decreased pump blood flow. 3.0,2 ktv decreased compared with previous measurement. 4.> 10% recirculation using urea method. 5.Prolonged coagulation time or cannulation difficulties in 3 consecutive dialysis sessions. 6.Pathologic physical examination with any other criteria. |
| Second generation surveillance of AVF | Experimental | Device: Second generation surveillance of AVF, Procedure: vital signs, Procedure: physical examination of AVF, Procedure: ktv test, Procedure: urea methodIn addition to the classical surveillance and monitoring methods, in the experimental group Doppler ultrasound and transonic dilution method will be performed on a quarterly basis. In addition to the classical alarm criteria and derived from the results in Doppler ultrasound an transonic dilution method the following alarm criteria would also be considered in the experimental group: 1. 25% or higher decreased in QA compared with previous measurement. 2. QA lower than 500 ml/min. 3. Stenotic area with a higher than 50% reduction of blood vessel lumen would be considered as alarm criteria only if it comes with a haemodynamic repercussion criteria defined as Peak systolic velocity (PSV) higher than 400 cm/sc, aliasing, or PSV ratio stenosis/pre-stenosis higher than 3. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Coagulopathy or hemoglobinopathy of any cause.
- Hospitalization of any cause in the previous month.
- VA related complications or dysfunction in the previous three months.
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 |
|---|---|---|
| Second generation surveillance of AVFAlso: Doppler ultrasound: M-Turbo. Sonosite., Transonic dilution method: Transonic System Inc HD-03Doppler ultrasound and transonic dilution method technique will be performed in the experimental group quarterly. QA will be measured by both techniques and haemodynamic repercussion stenosis will be evaluated by doppler ultrasound. | Device | Second generation surveillance of AVF |
| vital signsEffective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session | Procedure or surgery | Clasical Surveillance of AVF, Second generation surveillance of AVF |
| physical examination of AVFPredialysis physical examination of AVF every dialysis session. | Procedure or surgery | Clasical Surveillance of AVF, Second generation surveillance of AVF |
| ktv testWeekly ktv measurement using biosensors. In patients who have been dialyzed in monitors with no biosensors, ktv will be measured monthly using monocompartimental Daugirdas equation | Procedure or surgery | Clasical Surveillance of AVF, Second generation surveillance of AVF |
| urea methodQuarterly recirculation with urea method. | Procedure or surgery | Clasical Surveillance of AVF, Second generation surveillance of AVF |
Primary outcome
Improved primary patency rate in arteriovenous fistulae with the use of doppler ultrasound and transonic dilution method
Time frame: Up to 3 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).
7 secondary outcomes
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
Reproducibility in Doppler ultrasound technique
Time frame: Up to 3 years follow up.
Possible influence of different baseline items in the risk of thrombosis of native AVF
Time frame: Up to 3 years follow up
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Derived from this study: PubMed 28430315Aragoncillo 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.
- Derived from this study: PubMed 26391583Aragoncillo 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.
- Individual participant dataSharing planned: No
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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.
ANTONIO CIRUGEDA, MD principal investigator
HOSPITAL UNIVERSITARIO INFANTA SOFIA
SILVIA CALDES, MD study chair
HOSPITAL UNIVERSITARIO INFANTA SOFIA
YESIKA AMEZQUITA, MD study chair
CLINICA FUENSANTA
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Second generation surveillance of AVF, vital signs and physical examination of AVF in people with Thrombosis, run by Hospital Infanta Sofia at 5 sites in Spain.
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 4 inclusion and 3 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improved primary patency rate in arteriovenous fistulae with the use of doppler ultrasound and transonic dilution method (time frame: Up to 3 years follow up). 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 NCT02111655, which also lists 2 linked publications.
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 20 Jun 2017.