Vascular Access ComplicationNCT04472221
Arterio-arterial Vascular Access as a Novel Technique for Treatment of Venous Hypertention With Arterio-venous Vascular Access
A study testing Arterioarterial synthetic graft in people with Vascular Access Complication, run by Mansoura University at 1 site in Egypt.
Trial summary
Arterio-arterial vascular access, Arterio-venous synthetic access, Venous hypertension, Hemodialysis patients Purpose: To describe a technique used to treat a patient with Lt upper limb synthetic arterio-venous vascular access and venous hypertension of the same limb. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vascular Access Complication
- What is being tested?
- Arterioarterial synthetic graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Jun 2018to 21 Jun 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All vascular access with central venous hypertension with failed angioplasty
Who cannot join
- infected access or rupture access
Trial locations and contacts
1 site in 1 country.
About this study
Arterio-arterial vascular access, Arterio-venous synthetic access, Venous hypertension, Hemodialysis patients Purpose: To describe a technique used to treat a patient with Lt upper limb synthetic arterio-venous vascular access and venous hypertension of the same limb. Technique: the investigator expose the venous anastomosis of the graft by small longitudinal incision in the axilla and dissection of the axillary artery just parallel to the axillary vein , the investigator disconnect the graft from the axillary vein and do primary repair of the vein , then the investigator do end to side anastomosis of the graft to the axillary artery , after finishing this anastomosis the axillary artery ligated just below the anastomosis. Conclusion: the conversion of arterio-venous graft to arterio-arterial vascular access in precious access with venous hypertension lead to resolution of edema of venous hypertension and preservation of access for dialysis.
Read the detailed description
Abstract Purpose: To describe a technique used to treat a patient with Lt upper limb synthetic arterio-venous vascular access and venous hypertension of the same limb. Technique: we expose the venous anastomosis of the graft by small longitudinal incision in the axilla and dissection of the axillary artery just parallel to the axillary vein , the investigator disconnect the graft from the axillary vein and do primary repair of the vein , then investigator s do end to side anastomosis of the graft to the axillary artery , after finishing this anastomosis the axillary artery ligated just below the anastomosis. Conclusion: the conversion of arterio-venous graft to arterio-arterial vascular access in precious access with venous hypertension lead to resolution of edema of venous hypertension and preservation of access for dialysis.
Keywords: Arterio-arterial vascular access, Arterio-venous synthetic access, Venous hypertension, Hemodialysis patients.
Introduction:
In haemodialysis patients the investigator are confronted by patient with Left upper limb synthetic graft used for haemodialysis and the patient developed edema due to central venous occlusion ( venous hypertension) in the same limb. The other limb have no palpable pulse due to previous 3 operations for vascular access which ended by ligation of the brachial artery.
First the hope to dilatation of the central veins but this trial failed due to failure of the wire to cross the lesion, so we think to convert this arterio-venous graft to arterio-arterial access as we have previous experience with brachial aretrio-arterial vascular access.
One limitation of this technique was that the continuity of the brachial artery which will lead to thrombosis of the graft because of equal pressure in the graft and the brachial artery so ligation of the axillary artery below the proximal anastomosis was done despite our fear of ischaemia of the limb if the synthetic graft occluded later on.
Technique:
After failure of trial angioplasty of epsilateral central veins. This procedure was done either by local, regional, or general anesthesia (IV deprivan) according to the patient situation and surgeon preference.
Longitudinal incision (about 5-7cm) in the axilla at the arterio-venous anastomosis of the synthetic graft and along the course of the axillary artery , good hemostasis is needed because of the edema and the venous hypertension in the dilated collateral veins.
Good exposure of the end of the synthetic graft and mobilization of the axillary artery was done with ligation of intervening branches (a segment of 4-6 cm).
The synthetic graft catted and we do repair of the axillary vein. End to side anastomosis between the synthetic graft and the axillary artery by 6/0 proline then the axillary artery is ligated just below the anastomosis by 2/0 silk suture , now the blood is reversed in the synthetic graft and the blood flow from the axillary artery to the synthetic graft then to the brachial artery and radial and ulnar arteries.
Patients were discharged in the 2nd postoperative day unless need. Creep bandage was applied to the forearm and after 1-2 days the edema resolved and the patient regain the function of the upper limb and he can used the graft for dialysis immediately because the graft already healed and used previously for dialysis which is useful in those patients who has no venous access even for temporary catheter .
The same instructions as any arterio-arterial graft for hemodialysis were given to the patient and the medical stuff at dialysis unit as:
- no medications given at the AAPL to avoid intra-arterial injection and acute ischemia.
- Only pulse which can be palpated at the graft but no thrill.
- Patency of the graft is done by palpation of the distal pulsation (distal brachial or radial artery) or duplex.
- The puncture site needs more time of compression than that needed for AV grafts. (Khafagy et al.,)
- Conditions
- Vascular Access Complication
- Being tested
- Arterioarterial synthetic graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterioarterial synthetic graftProcedure or surgery
Synthetic poly tetraflouroethylene graft
| Study group | Role | What they receive |
|---|---|---|
| Vascular Access Venous Hypertension | Experimental | Swollen upper limb with synthetic Arteriovenous graft Receives: Procedure: Arterioarterial synthetic graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease the swelling of the upper limb gradually
Measure of the whole cicumference
Measured: Six month
Patency of the dialysis access
Duplex ultrasound assessment of the patency
Measured: Six month
Effeicient dialysis
Continue haemodialysis of the access for 4 hours
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start21 Jun 2018
- Primary completion21 Jun 2021 (estimated)
- Study completion21 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Access ComplicationStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472221
- Sponsor's protocol ID
- R.20.06.909 - 2020/06/24
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterio-arterial Vascular Access as a Novel Technique for Treatment of Venous Hypertention With Arterio-venous Vascular Access
- ClinicalTrials.gov ID
- NCT04472221
- Acronym / sponsor ID
- R.20.06.909 - 2020/06/24
- Conditions
- Vascular Access Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 21 Jun 2018 (actual)
- Primary completion
- 21 Jun 2021 (estimated)
- Study completion
- 21 Jun 2021 (estimated)
- First posted
- 15 Jul 2020 (actual)
- 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.
Arterio-arterial vascular access, Arterio-venous synthetic access, Venous hypertension, Hemodialysis patients Purpose: To describe a technique used to treat a patient with Lt upper limb synthetic arterio-venous vascular access and venous hypertension of the same limb. Technique: the investigator expose the venous anastomosis of the graft by small longitudinal incision in the axilla and dissection of the axillary artery just parallel to the axillary vein , the investigator disconnect the graft from the axillary vein and do primary repair of the vein , then the investigator do end to side anastomosis of the graft to the axillary artery , after finishing this anastomosis the axillary artery ligated just below the anastomosis. Conclusion: the conversion of arterio-venous graft to arterio-arterial vascular access in precious access with venous hypertension lead to resolution of edema of venous hypertension and preservation of access for dialysis.
Detailed description
Abstract Purpose: To describe a technique used to treat a patient with Lt upper limb synthetic arterio-venous vascular access and venous hypertension of the same limb. Technique: we expose the venous anastomosis of the graft by small longitudinal incision in the axilla and dissection of the axillary artery just parallel to the axillary vein , the investigator disconnect the graft from the axillary vein and do primary repair of the vein , then investigator s do end to side anastomosis of the graft to the axillary artery , after finishing this anastomosis the axillary artery ligated just below the anastomosis. Conclusion: the conversion of arterio-venous graft to arterio-arterial vascular access in precious access with venous hypertension lead to resolution of edema of venous hypertension and preservation of access for dialysis.
Keywords: Arterio-arterial vascular access, Arterio-venous synthetic access, Venous hypertension, Hemodialysis patients.
Introduction:
In haemodialysis patients the investigator are confronted by patient with Left upper limb synthetic graft used for haemodialysis and the patient developed edema due to central venous occlusion ( venous hypertension) in the same limb. The other limb have no palpable pulse due to previous 3 operations for vascular access which ended by ligation of the brachial artery.
First the hope to dilatation of the central veins but this trial failed due to failure of the wire to cross the lesion, so we think to convert this arterio-venous graft to arterio-arterial access as we have previous experience with brachial aretrio-arterial vascular access.
One limitation of this technique was that the continuity of the brachial artery which will lead to thrombosis of the graft because of equal pressure in the graft and the brachial artery so ligation of the axillary artery below the proximal anastomosis was done despite our fear of ischaemia of the limb if the synthetic graft occluded later on.
Technique:
After failure of trial angioplasty of epsilateral central veins. This procedure was done either by local, regional, or general anesthesia (IV deprivan) according to the patient situation and surgeon preference.
Longitudinal incision (about 5-7cm) in the axilla at the arterio-venous anastomosis of the synthetic graft and along the course of the axillary artery , good hemostasis is needed because of the edema and the venous hypertension in the dilated collateral veins.
Good exposure of the end of the synthetic graft and mobilization of the axillary artery was done with ligation of intervening branches (a segment of 4-6 cm).
The synthetic graft catted and we do repair of the axillary vein. End to side anastomosis between the synthetic graft and the axillary artery by 6/0 proline then the axillary artery is ligated just below the anastomosis by 2/0 silk suture , now the blood is reversed in the synthetic graft and the blood flow from the axillary artery to the synthetic graft then to the brachial artery and radial and ulnar arteries.
Patients were discharged in the 2nd postoperative day unless need. Creep bandage was applied to the forearm and after 1-2 days the edema resolved and the patient regain the function of the upper limb and he can used the graft for dialysis immediately because the graft already healed and used previously for dialysis which is useful in those patients who has no venous access even for temporary catheter .
The same instructions as any arterio-arterial graft for hemodialysis were given to the patient and the medical stuff at dialysis unit as:
- no medications given at the AAPL to avoid intra-arterial injection and acute ischemia.
- Only pulse which can be palpated at the graft but no thrill.
- Patency of the graft is done by palpation of the distal pulsation (distal brachial or radial artery) or duplex.
- The puncture site needs more time of compression than that needed for AV grafts. (Khafagy et al.,)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental
| Arm | Type | Receives |
|---|---|---|
| Vascular Access Venous Hypertension | Experimental | Procedure: Arterioarterial synthetic graftSwollen upper limb with synthetic Arteriovenous graft |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All vascular access with central venous hypertension with failed angioplasty
Key exclusion criteria (1 listed)
- infected access or rupture access
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 |
|---|---|---|
| Arterioarterial synthetic graftSynthetic poly tetraflouroethylene graft | Procedure or surgery | Vascular Access Venous Hypertension |
Primary outcome
Decrease the swelling of the upper limb gradually
Time frame: Six month
Measure of the whole cicumference
Patency of the dialysis access
Time frame: Six month
Duplex ultrasound assessment of the patency
Effeicient dialysis
Time frame: 4 hours
Continue haemodialysis of the access for 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterioarterial synthetic graft in people with Vascular Access Complication, run by Mansoura University at 1 site in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed S. Abdelgawwad, MD (01003919077 ext. 002, mshukri33@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease the swelling of the upper limb gradually (time frame: Six month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2020.