<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04472221</url>
  </required_header>
  <id_info>
    <org_study_id>R.20.06.909 - 2020/06/24</org_study_id>
    <nct_id>NCT04472221</nct_id>
  </id_info>
  <brief_title>Arterio-arterial Vascular Access as a Novel Technique for Treatment of Venous Hypertention With Arterio-venous Vascular Access</brief_title>
  <official_title>Arterio-arterial Vascular Access as a Novel Technique for Treatment of Venous Hypertention With Arterio-venous Vascular Access</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mansoura University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Arterio-arterial vascular access, Arterio-venous synthetic access, Venous hypertension,&#xD;
      Hemodialysis patients Purpose: To describe a technique used to treat a patient with Lt upper&#xD;
      limb synthetic arterio-venous vascular access and venous hypertension of the same limb.&#xD;
      Technique: the investigator expose the venous anastomosis of the graft by small longitudinal&#xD;
      incision in the axilla and dissection of the axillary artery just parallel to the axillary&#xD;
      vein , the investigator disconnect the graft from the axillary vein and do primary repair of&#xD;
      the vein , then the investigator do end to side anastomosis of the graft to the axillary&#xD;
      artery , after finishing this anastomosis the axillary artery ligated just below the&#xD;
      anastomosis. Conclusion: the conversion of arterio-venous graft to arterio-arterial vascular&#xD;
      access in precious access with venous hypertension lead to resolution of edema of venous&#xD;
      hypertension and preservation of access for dialysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Abstract Purpose: To describe a technique used to treat a patient with Lt upper limb&#xD;
      synthetic arterio-venous vascular access and venous hypertension of the same limb. Technique:&#xD;
      we expose the venous anastomosis of the graft by small longitudinal incision in the axilla&#xD;
      and dissection of the axillary artery just parallel to the axillary vein , the investigator&#xD;
      disconnect the graft from the axillary vein and do primary repair of the vein , then&#xD;
      investigator s do end to side anastomosis of the graft to the axillary artery , after&#xD;
      finishing this anastomosis the axillary artery ligated just below the anastomosis.&#xD;
      Conclusion: the conversion of arterio-venous graft to arterio-arterial vascular access in&#xD;
      precious access with venous hypertension lead to resolution of edema of venous hypertension&#xD;
      and preservation of access for dialysis.&#xD;
&#xD;
      Keywords: Arterio-arterial vascular access, Arterio-venous synthetic access, Venous&#xD;
      hypertension, Hemodialysis patients.&#xD;
&#xD;
      Introduction:&#xD;
&#xD;
      In haemodialysis patients the investigator are confronted by patient with Left upper limb&#xD;
      synthetic graft used for haemodialysis and the patient developed edema due to central venous&#xD;
      occlusion ( venous hypertension) in the same limb. The other limb have no palpable pulse due&#xD;
      to previous 3 operations for vascular access which ended by ligation of the brachial artery.&#xD;
&#xD;
      First the hope to dilatation of the central veins but this trial failed due to failure of the&#xD;
      wire to cross the lesion, so we think to convert this arterio-venous graft to&#xD;
      arterio-arterial access as we have previous experience with brachial aretrio-arterial&#xD;
      vascular access.&#xD;
&#xD;
      One limitation of this technique was that the continuity of the brachial artery which will&#xD;
      lead to thrombosis of the graft because of equal pressure in the graft and the brachial&#xD;
      artery so ligation of the axillary artery below the proximal anastomosis was done despite our&#xD;
      fear of ischaemia of the limb if the synthetic graft occluded later on.&#xD;
&#xD;
      Technique:&#xD;
&#xD;
      After failure of trial angioplasty of epsilateral central veins. This procedure was done&#xD;
      either by local, regional, or general anesthesia (IV deprivan) according to the patient&#xD;
      situation and surgeon preference.&#xD;
&#xD;
      Longitudinal incision (about 5-7cm) in the axilla at the arterio-venous anastomosis of the&#xD;
      synthetic graft and along the course of the axillary artery , good hemostasis is needed&#xD;
      because of the edema and the venous hypertension in the dilated collateral veins.&#xD;
&#xD;
      Good exposure of the end of the synthetic graft and mobilization of the axillary artery was&#xD;
      done with ligation of intervening branches (a segment of 4-6 cm).&#xD;
&#xD;
      The synthetic graft catted and we do repair of the axillary vein. End to side anastomosis&#xD;
      between the synthetic graft and the axillary artery by 6/0 proline then the axillary artery&#xD;
      is ligated just below the anastomosis by 2/0 silk suture , now the blood is reversed in the&#xD;
      synthetic graft and the blood flow from the axillary artery to the synthetic graft then to&#xD;
      the brachial artery and radial and ulnar arteries.&#xD;
&#xD;
      Patients were discharged in the 2nd postoperative day unless need. Creep bandage was applied&#xD;
      to the forearm and after 1-2 days the edema resolved and the patient regain the function of&#xD;
      the upper limb and he can used the graft for dialysis immediately because the graft already&#xD;
      healed and used previously for dialysis which is useful in those patients who has no venous&#xD;
      access even for temporary catheter .&#xD;
&#xD;
      The same instructions as any arterio-arterial graft for hemodialysis were given to the&#xD;
      patient and the medical stuff at dialysis unit as:&#xD;
&#xD;
        -  no medications given at the AAPL to avoid intra-arterial injection and acute ischemia.&#xD;
&#xD;
        -  Only pulse which can be palpated at the graft but no thrill.&#xD;
&#xD;
        -  Patency of the graft is done by palpation of the distal pulsation (distal brachial or&#xD;
           radial artery) or duplex.&#xD;
&#xD;
        -  The puncture site needs more time of compression than that needed for AV grafts.&#xD;
           (Khafagy et al.,)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 21, 2018</start_date>
  <completion_date type="Anticipated">June 21, 2021</completion_date>
  <primary_completion_date type="Anticipated">June 21, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Experimental</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease the swelling of the upper limb gradually</measure>
    <time_frame>Six month</time_frame>
    <description>Measure of the whole cicumference</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patency of the dialysis access</measure>
    <time_frame>Six month</time_frame>
    <description>Duplex ultrasound assessment of the patency</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Effeicient dialysis</measure>
    <time_frame>4 hours</time_frame>
    <description>Continue haemodialysis of the access for 4 hours</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Vascular Access Complication</condition>
  <arm_group>
    <arm_group_label>Vascular Access Venous Hypertension</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Swollen upper limb with synthetic Arteriovenous graft</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Arterioarterial synthetic graft</intervention_name>
    <description>Synthetic poly tetraflouroethylene graft</description>
    <arm_group_label>Vascular Access Venous Hypertension</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All vascular access with central venous hypertension with failed angioplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  infected access or rupture access&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohamed S. Abdelgawwad, MD</last_name>
    <phone>01003919077</phone>
    <phone_ext>002</phone_ext>
    <email>mshukri33@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tamer A. Khafagy, PhD</last_name>
    <phone>01011889500</phone>
    <phone_ext>002</phone_ext>
    <email>Dr_Tamerkhafagy@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Mansoura University</name>
      <address>
        <city>Mansoura</city>
        <zip>35615</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04472221
org study id: R.20.06.909 - 2020/06/24
nct id: NCT04472221
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.,)
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Experimental
primary purpose: Treatment
masking: None (Open Label)
measure: Decrease the swelling of the upper limb gradually
time frame: Six month
description: Measure of the whole cicumference
measure: Patency of the dialysis access
time frame: Six month
description: Duplex ultrasound assessment of the patency
measure: Effeicient dialysis
time frame: 4 hours
description: Continue haemodialysis of the access for 4 hours
arm group label: Vascular Access Venous Hypertension
arm group type: Experimental
description: Swollen upper limb with synthetic Arteriovenous graft
intervention type: Procedure
intervention name: Arterioarterial synthetic graft
description: Synthetic poly tetraflouroethylene graft
arm group label: Vascular Access Venous Hypertension
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mohamed S. Abdelgawwad, MD
phone: 01003919077
phone ext: 002
email: mshukri33@gmail.com
last name: Tamer A. Khafagy, PhD
phone: 01011889500
phone ext: 002
email: Dr_Tamerkhafagy@yahoo.com
facility: 
status: Recruiting
country: Egypt
responsible party type: Sponsor
sharing ipd: No