<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/NCT03820401</url>
  </required_header>
  <id_info>
    <org_study_id>UGent_FiberClotting_1</org_study_id>
    <nct_id>NCT03820401</nct_id>
  </id_info>
  <brief_title>Dialysis Performance of Different Dialyzer Membranes Using Different Coagulation Strategies</brief_title>
  <official_title>Quantification of Dialysis Performance of Different Dialyzer Membranes With Different Coagulation Strategies, Using a Reference microCT Scanning Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Ghent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Ghent</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Coagulation within the dialyzer membrane fibres is an obvious biological sign of&#xD;
      bio-incompatibility. To avoid clotting during extracorporeal treatment, an anticoagulant is&#xD;
      added to the circuit, resulting in an increased risk for bleeding complications.&#xD;
&#xD;
      In addition, there is evidence that a substantial number of fibers can become blocked before&#xD;
      this is reflected in routinely observed parameters, or in termination of the dialysis&#xD;
      session. Little is known about the impact of such subclinical clotting on dialyzer&#xD;
      performance in terms of solute clearance.&#xD;
&#xD;
      Membrane clogging due to deposition of proteins and red blood cells on the dialysis membrane&#xD;
      may influence both the diffusive and convective transport characteristics of the dialyzer&#xD;
      membrane before leading to complete dialyzer clotting.&#xD;
&#xD;
      In 2018, the invesitgators described a method to objectively count the number of blocked&#xD;
      fibres inside a dialyzer using a micro-CT scanning technique.&#xD;
&#xD;
      In the present trial, the investigators use this method to assess the resistance of the&#xD;
      dialyzer to clotting, and to evaluate the impact of subclinical fibre blocking on solute&#xD;
      removal and thus performance of a dialyzer during a dialysis session.&#xD;
&#xD;
      The aim of this randomized cross-over study is to objectively quantify the performance of&#xD;
      different dialyzer membranes: ATA™ membrane in the Solacea™ dialyzer, polysulfone membrane in&#xD;
      the FX800 dialyzer, and the heparin-coated AN membrane in the Evodial dialyzer, and this with&#xD;
      different anticoagulation strategies.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This single centre, randomized cross-over study includes ten consecutive stable chronic&#xD;
      hemodialysis (HD) patients who experienced stable dialysis sessions during the last 4 weeks,&#xD;
      and had no known coagulation disorder, active inflammation or malignancy.&#xD;
&#xD;
      Double-needle vascular access is achieved through a native arterio-venous fistula or a&#xD;
      well-functioning double lumen tunnelled central venous catheter.&#xD;
&#xD;
      In a first test series, each patient is dialyzed for 240min (at midweek) in 4 different&#xD;
      regimens, randomly using 2 different dialyzers and 2 different anticoagulation schemes.&#xD;
      Patients receive their regular brand of Low-Molecular-Weight Heparin anticoagulation at the&#xD;
      beginning of the dialysis session, and this randomly either at their regular dose (full dose&#xD;
      1/1) or at only 50% of their regular dose (half dose 1/2). All test sessions are performed&#xD;
      with blood flow at 300mL/min and dialysate flow at 500mL/min in post dilution&#xD;
      hemodiafiltration (HDF) mode (substitution flow 75mL/min). Ultrafiltration rates is set&#xD;
      according to the patient's interdialytic weight gain and clinical status:&#xD;
&#xD;
        1. ATA™ Solacea 19H - HDF - 1/1 anticoagulation&#xD;
&#xD;
        2. ATA™ Solacea 19H - HDF - 1/2 anticoagulation&#xD;
&#xD;
        3. polysulfone FX800 - HDF - 1/1 anticoagulation&#xD;
&#xD;
        4. polysulfone FX800 - HDF - 1/2 anticoagulation&#xD;
&#xD;
      During the 4 experimental midweek sessions, blood is sampled from the arterial and venous&#xD;
      blood lines, and spent dialysate is sampled from the outlet line, all at 60min after the&#xD;
      dialysis start. Blood samples are immediately centrifuged and serum and dialysate are stored&#xD;
      at -80°C until batch analysis.&#xD;
&#xD;
      Concentrations of urea, kappa and lambda free light chains, and myoglobin are determined.&#xD;
      Extraction ratios and adsorption on the membrane are calculated from concentrations.&#xD;
&#xD;
      At the end of the dialysis session, a standard rinsing procedure of the hemodialyzer is&#xD;
      performed using exact 300mL rinsing solution. Next, the hemodialyzer is dried using&#xD;
      continuous positive pressure ventilation. Dialyzer fibre blocking is visualized in the&#xD;
      dialyzer outlet potting using a 3D CT scanning technique on micrometer resolution. HECTOR is&#xD;
      a High Energy CT scanner Optimized for Research, built by the Ghent University Centre for&#xD;
      X-ray Tomography (UGCT) in collaboration with the UGCT spin-off company XRE (Gent, Belgium).&#xD;
      In front of the X-ray source, the dialyzer is mounted vertically on a precision rotation&#xD;
      stage, and radiographies were recorded over 360° with an angular interval of 0.15°. Scan&#xD;
      conditions are optimized to maximize the signal-to-noise ratio based on the sample size and&#xD;
      structure, and the scanner properties. The tube voltage is set at 80kV, at a power of 20&#xD;
      Watts, the maximal power that allowed imaging at a resolution of 25µm. A total of 2401&#xD;
      projections are recorded with 500ms exposure each, resulting in a total exposure time of 20&#xD;
      minutes. Acquired images at 0 (projection 1) and 360° (projection 2401) are compared to&#xD;
      exclude movement of the hemodialyzer during the scanning process. Reconstruction of the raw&#xD;
      projection data is performed with the Octopus Reconstruction software package, licensed by&#xD;
      XRE23.&#xD;
&#xD;
      Fibers are counted in the central cross-section of the dialyzer outlet potting in a&#xD;
      computer-based way using the Fiji image processing toolkit of ImageJ analysis software&#xD;
      (ImageJ 1.51H, NIH, Bethesda, USA), an open-source platform for biological-image analysis.&#xD;
&#xD;
      In a second test series in 10 stable HD patients, no blood sampling is performed but&#xD;
      dialyzers are scanned post dialysis. The following different dialyzers in HD modus at midweek&#xD;
      are tested:&#xD;
&#xD;
        1. ATA™ Solacea 19H - HD - 1/1 anticoagulation&#xD;
&#xD;
        2. ATA™ Solacea 19H - HD - 1/2 anticoagulation&#xD;
&#xD;
        3. polysulfone FX800 - HD - 1/1 anticoagulation&#xD;
&#xD;
        4. polysulfone FX800 - HD - 1/2 anticoagulation&#xD;
&#xD;
        5. polysulfone FX800 - HD - 1/2 anticoagulation - with predialysis albmuin priming of the&#xD;
           membrane&#xD;
&#xD;
        6. Evodial - HD - no anticoagulation&#xD;
&#xD;
        7. Evodial - HD - no anticoagulation - with predialysis albmuin priming of the membrane&#xD;
&#xD;
      In a third test series in 10 stable HD patients, no blood sampling is performed but dialyzers&#xD;
      are scanned post dialysis. The following different dialyzers at midweek are tested:&#xD;
&#xD;
        1. ATA™ Solacea 19H - pre dilution HDF (substitution 150mL/min) - 1/4 anticoagulation&#xD;
&#xD;
        2. ATA™ Solacea 19H - post dilution HDF (substitution 75mL/min) - 1/4 anticoagulation&#xD;
&#xD;
        3. ATA™ Solacea 19H - HD - 1/4 anticoagulation&#xD;
&#xD;
        4. ATA™ Solacea 19H - pre dilution HDF (substitution 150mL/min) - no anticoagulation&#xD;
&#xD;
        5. ATA™ Solacea 19H - post dilution HDF (substitution 75mL/min) - no anticoagulation&#xD;
&#xD;
        6. ATA™ Solacea 19H - HD - no anticoagulation&#xD;
&#xD;
      First outcome measure: relative number of open fibers in each tested dialyzer. Second outcome&#xD;
      measure: dialyzer performance (extraction ratio, adsorption).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2018</start_date>
  <completion_date type="Actual">January 17, 2019</completion_date>
  <primary_completion_date type="Actual">May 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of open fibres in the dialyzer</measure>
    <time_frame>17 weeks</time_frame>
    <description>Number of open fibres as assessed post dialysis by a reference microCT scanning technique</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Extraction ratio of three middle molecules in the dialyzer</measure>
    <time_frame>4 weeks</time_frame>
    <description>Extraction ratio from myoglobin, kappa and lambda free light chains as calculated from their concentrations at the dialyzer inlet en outlet</description>
  </secondary_outcome>
  <number_of_arms>17</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hemodialysis</condition>
  <condition>Coagulation</condition>
  <arm_group>
    <arm_group_label>Solacea_postHDF_1/1anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: Solacea dialyzer (Nipro, Japan)&#xD;
choice of dialysis mode: post dilution hemodiafiltration&#xD;
choice of anticoagulation strategy: standard anticoagulation dose&#xD;
measurements:&#xD;
blood &amp; dialysate sampling at 60min after dialysis start&#xD;
microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solacea_postHDF_1/2anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: Solacea dialyzer (Nipro Japan)&#xD;
choice of dialysis mode: post dilution hemodiafiltration&#xD;
choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose&#xD;
measurements:&#xD;
blood &amp; dialysate sampling at 60min after dialysis start&#xD;
microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FX800_postHDF_1/1anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany)&#xD;
choice of dialysis mode: post dilution hemodiafiltration&#xD;
choice of anticoagulation strategy: standard anticoagulation dose&#xD;
measurements:&#xD;
blood &amp; dialysate sampling at 60min after dialysis start&#xD;
microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FX800_postHDF_1/2anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany)&#xD;
choice of dialysis mode: post dilution hemodiafiltration&#xD;
choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose&#xD;
measurements:&#xD;
blood &amp; dialysate sampling at 60min after dialysis start&#xD;
microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solacea_HD_1/1anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: Solacea dialyzer (Nipro, Japan)&#xD;
choice of dialysis mode: hemodialysis&#xD;
choice of anticoagulation strategy: standard anticoagulation dose&#xD;
measurement:&#xD;
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solacea_HD_1/2anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: Solacea dialyzer (Nipro, Japan)&#xD;
choice of dialysis mode: hemodialysis&#xD;
choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose&#xD;
measurements:&#xD;
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FX800_HD_1/1anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany)&#xD;
choice of dialysis mode: hemodialysis&#xD;
choice of anticoagulation strategy: standard anticoagulation dose&#xD;
measurements:&#xD;
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FX800_HD_1/2anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany)&#xD;
choice of dialysis mode: hemodialysis&#xD;
choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose&#xD;
measurements:&#xD;
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FX800_HD_1/2anticoagulation_albuprime</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany)&#xD;
choice of dialysis mode: hemodialysis&#xD;
choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose&#xD;
preparation of dialyzer: the dialyzer was preprimed with albumin solution&#xD;
measurement:&#xD;
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evodial_HD_no anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: Evodial 1.3 (Baxter, USA)&#xD;
choice of dialysis mode: hemodialysis&#xD;
choice of anticoagulation strategy: no anticoagulation is administered&#xD;
measurement:&#xD;
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Evodial_HD_no anticoagulation_albuprime</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: Evodial 1.3 (Baxter, USA)&#xD;
choice of dialysis mode: hemodialysis&#xD;
choice of anticoagulation strategy: no anticoagulation is administered&#xD;
preparation of dialyzer: the dialyzer was preprimed with albumin solution&#xD;
measurement:&#xD;
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solacea_preHDF_1/4anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: Solacea dialyzer (Nipro Japan)&#xD;
choice of dialysis mode: pre dilution hemodiafiltration&#xD;
choice of anticoagulation strategy: the patient receives only 1/4th of his/her standard anticoagulation dose&#xD;
measurements:&#xD;
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solacea_postHDF_1/4anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: Solacea dialyzer (Nipro Japan)&#xD;
choice of dialysis mode: post dilution hemodiafiltration&#xD;
choice of anticoagulation strategy: the patient receives only 1/4th of his/her standard anticoagulation dose&#xD;
measurements:&#xD;
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solacea_HD_1/4anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: Solacea dialyzer (Nipro Japan)&#xD;
choice of dialysis mode: hemodialysis&#xD;
choice of anticoagulation strategy: the patient receives only 1/4th of his/her standard anticoagulation dose&#xD;
measurements:microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solacea_preHDF_no anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: Solacea dialyzer (Nipro Japan)&#xD;
choice of dialysis mode: pre dilution hemodiafiltration&#xD;
choice of anticoagulation strategy: no anticoagulation is administered&#xD;
measurements:&#xD;
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solacea_postHDF_no anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: Solacea dialyzer (Nipro Japan)&#xD;
choice of dialysis mode: post dilution hemodiafiltration&#xD;
choice of anticoagulation strategy: no anticoagulation is administered&#xD;
measurements:&#xD;
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solacea_HD_no anticoagulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intervention:&#xD;
choice of dialyzer: Solacea dialyzer (Nipro Japan)&#xD;
choice of dialysis mode: hemodialysis&#xD;
choice of anticoagulation strategy: no anticoagulation is administered&#xD;
measurements:&#xD;
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>choice of dialyzer</intervention_name>
    <description>Fiber blocking is calculated in different commercially available dialyzers</description>
    <arm_group_label>Evodial_HD_no anticoagulation</arm_group_label>
    <arm_group_label>Evodial_HD_no anticoagulation_albuprime</arm_group_label>
    <arm_group_label>FX800_HD_1/1anticoagulation</arm_group_label>
    <arm_group_label>FX800_HD_1/2anticoagulation</arm_group_label>
    <arm_group_label>FX800_HD_1/2anticoagulation_albuprime</arm_group_label>
    <arm_group_label>FX800_postHDF_1/1anticoagulation</arm_group_label>
    <arm_group_label>FX800_postHDF_1/2anticoagulation</arm_group_label>
    <arm_group_label>Solacea_HD_1/1anticoagulation</arm_group_label>
    <arm_group_label>Solacea_HD_1/2anticoagulation</arm_group_label>
    <arm_group_label>Solacea_HD_1/4anticoagulation</arm_group_label>
    <arm_group_label>Solacea_HD_no anticoagulation</arm_group_label>
    <arm_group_label>Solacea_postHDF_1/1anticoagulation</arm_group_label>
    <arm_group_label>Solacea_postHDF_1/2anticoagulation</arm_group_label>
    <arm_group_label>Solacea_postHDF_1/4anticoagulation</arm_group_label>
    <arm_group_label>Solacea_postHDF_no anticoagulation</arm_group_label>
    <arm_group_label>Solacea_preHDF_1/4anticoagulation</arm_group_label>
    <arm_group_label>Solacea_preHDF_no anticoagulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>choice of dialysis mode</intervention_name>
    <description>Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies</description>
    <arm_group_label>Evodial_HD_no anticoagulation</arm_group_label>
    <arm_group_label>Evodial_HD_no anticoagulation_albuprime</arm_group_label>
    <arm_group_label>FX800_HD_1/1anticoagulation</arm_group_label>
    <arm_group_label>FX800_HD_1/2anticoagulation</arm_group_label>
    <arm_group_label>FX800_HD_1/2anticoagulation_albuprime</arm_group_label>
    <arm_group_label>FX800_postHDF_1/1anticoagulation</arm_group_label>
    <arm_group_label>FX800_postHDF_1/2anticoagulation</arm_group_label>
    <arm_group_label>Solacea_HD_1/1anticoagulation</arm_group_label>
    <arm_group_label>Solacea_HD_1/2anticoagulation</arm_group_label>
    <arm_group_label>Solacea_HD_1/4anticoagulation</arm_group_label>
    <arm_group_label>Solacea_HD_no anticoagulation</arm_group_label>
    <arm_group_label>Solacea_postHDF_1/1anticoagulation</arm_group_label>
    <arm_group_label>Solacea_postHDF_1/2anticoagulation</arm_group_label>
    <arm_group_label>Solacea_postHDF_1/4anticoagulation</arm_group_label>
    <arm_group_label>Solacea_postHDF_no anticoagulation</arm_group_label>
    <arm_group_label>Solacea_preHDF_1/4anticoagulation</arm_group_label>
    <arm_group_label>Solacea_preHDF_no anticoagulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>choice of anticoagulation strategy</intervention_name>
    <description>Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies</description>
    <arm_group_label>Evodial_HD_no anticoagulation</arm_group_label>
    <arm_group_label>Evodial_HD_no anticoagulation_albuprime</arm_group_label>
    <arm_group_label>FX800_HD_1/1anticoagulation</arm_group_label>
    <arm_group_label>FX800_HD_1/2anticoagulation</arm_group_label>
    <arm_group_label>FX800_HD_1/2anticoagulation_albuprime</arm_group_label>
    <arm_group_label>FX800_postHDF_1/1anticoagulation</arm_group_label>
    <arm_group_label>FX800_postHDF_1/2anticoagulation</arm_group_label>
    <arm_group_label>Solacea_HD_1/1anticoagulation</arm_group_label>
    <arm_group_label>Solacea_HD_1/2anticoagulation</arm_group_label>
    <arm_group_label>Solacea_HD_1/4anticoagulation</arm_group_label>
    <arm_group_label>Solacea_HD_no anticoagulation</arm_group_label>
    <arm_group_label>Solacea_postHDF_1/1anticoagulation</arm_group_label>
    <arm_group_label>Solacea_postHDF_1/2anticoagulation</arm_group_label>
    <arm_group_label>Solacea_postHDF_1/4anticoagulation</arm_group_label>
    <arm_group_label>Solacea_postHDF_no anticoagulation</arm_group_label>
    <arm_group_label>Solacea_preHDF_1/4anticoagulation</arm_group_label>
    <arm_group_label>Solacea_preHDF_no anticoagulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>preparation of dialyzer</intervention_name>
    <description>Fiber blocking is calculated in different commercially available dialyzers either preprimed with Albumin or not</description>
    <arm_group_label>Evodial_HD_no anticoagulation_albuprime</arm_group_label>
    <arm_group_label>FX800_HD_1/2anticoagulation</arm_group_label>
    <arm_group_label>FX800_HD_1/2anticoagulation_albuprime</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  experienced stable dialysis sessions during the last 4 weeks&#xD;
&#xD;
          -  double needle/lumen well-functioning vascular access&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known coagulation disorder&#xD;
&#xD;
          -  active inflammation&#xD;
&#xD;
          -  malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ghent University Hospital - Nephrology</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <results_reference>
    <citation>Vanommeslaeghe F, Van Biesen W, Dierick M, Boone M, Dhondt A, Eloot S. Micro-computed tomography for the quantification of blocked fibers in hemodialyzers. Sci Rep. 2018 Feb 8;8(1):2677. doi: 10.1038/s41598-018-20898-w.</citation>
    <PMID>29422614</PMID>
  </results_reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>hemodialyzer</keyword>
  <keyword>fibre clotting</keyword>
  <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/NCT03820401
org study id: UGent_FiberClotting_1
nct id: NCT03820401
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Coagulation within the dialyzer membrane fibres is an obvious biological sign of
      bio-incompatibility. To avoid clotting during extracorporeal treatment, an anticoagulant is
      added to the circuit, resulting in an increased risk for bleeding complications.

      In addition, there is evidence that a substantial number of fibers can become blocked before
      this is reflected in routinely observed parameters, or in termination of the dialysis
      session. Little is known about the impact of such subclinical clotting on dialyzer
      performance in terms of solute clearance.

      Membrane clogging due to deposition of proteins and red blood cells on the dialysis membrane
      may influence both the diffusive and convective transport characteristics of the dialyzer
      membrane before leading to complete dialyzer clotting.

      In 2018, the invesitgators described a method to objectively count the number of blocked
      fibres inside a dialyzer using a micro-CT scanning technique.

      In the present trial, the investigators use this method to assess the resistance of the
      dialyzer to clotting, and to evaluate the impact of subclinical fibre blocking on solute
      removal and thus performance of a dialyzer during a dialysis session.

      The aim of this randomized cross-over study is to objectively quantify the performance of
      different dialyzer membranes: ATA™ membrane in the Solacea™ dialyzer, polysulfone membrane in
      the FX800 dialyzer, and the heparin-coated AN membrane in the Evodial dialyzer, and this with
      different anticoagulation strategies.
This single centre, randomized cross-over study includes ten consecutive stable chronic
      hemodialysis (HD) patients who experienced stable dialysis sessions during the last 4 weeks,
      and had no known coagulation disorder, active inflammation or malignancy.

      Double-needle vascular access is achieved through a native arterio-venous fistula or a
      well-functioning double lumen tunnelled central venous catheter.

      In a first test series, each patient is dialyzed for 240min (at midweek) in 4 different
      regimens, randomly using 2 different dialyzers and 2 different anticoagulation schemes.
      Patients receive their regular brand of Low-Molecular-Weight Heparin anticoagulation at the
      beginning of the dialysis session, and this randomly either at their regular dose (full dose
      1/1) or at only 50% of their regular dose (half dose 1/2). All test sessions are performed
      with blood flow at 300mL/min and dialysate flow at 500mL/min in post dilution
      hemodiafiltration (HDF) mode (substitution flow 75mL/min). Ultrafiltration rates is set
      according to the patient's interdialytic weight gain and clinical status:

        1. ATA™ Solacea 19H - HDF - 1/1 anticoagulation

        2. ATA™ Solacea 19H - HDF - 1/2 anticoagulation

        3. polysulfone FX800 - HDF - 1/1 anticoagulation

        4. polysulfone FX800 - HDF - 1/2 anticoagulation

      During the 4 experimental midweek sessions, blood is sampled from the arterial and venous
      blood lines, and spent dialysate is sampled from the outlet line, all at 60min after the
      dialysis start. Blood samples are immediately centrifuged and serum and dialysate are stored
      at -80°C until batch analysis.

      Concentrations of urea, kappa and lambda free light chains, and myoglobin are determined.
      Extraction ratios and adsorption on the membrane are calculated from concentrations.

      At the end of the dialysis session, a standard rinsing procedure of the hemodialyzer is
      performed using exact 300mL rinsing solution. Next, the hemodialyzer is dried using
      continuous positive pressure ventilation. Dialyzer fibre blocking is visualized in the
      dialyzer outlet potting using a 3D CT scanning technique on micrometer resolution. HECTOR is
      a High Energy CT scanner Optimized for Research, built by the Ghent University Centre for
      X-ray Tomography (UGCT) in collaboration with the UGCT spin-off company XRE (Gent, Belgium).
      In front of the X-ray source, the dialyzer is mounted vertically on a precision rotation
      stage, and radiographies were recorded over 360° with an angular interval of 0.15°. Scan
      conditions are optimized to maximize the signal-to-noise ratio based on the sample size and
      structure, and the scanner properties. The tube voltage is set at 80kV, at a power of 20
      Watts, the maximal power that allowed imaging at a resolution of 25µm. A total of 2401
      projections are recorded with 500ms exposure each, resulting in a total exposure time of 20
      minutes. Acquired images at 0 (projection 1) and 360° (projection 2401) are compared to
      exclude movement of the hemodialyzer during the scanning process. Reconstruction of the raw
      projection data is performed with the Octopus Reconstruction software package, licensed by
      XRE23.

      Fibers are counted in the central cross-section of the dialyzer outlet potting in a
      computer-based way using the Fiji image processing toolkit of ImageJ analysis software
      (ImageJ 1.51H, NIH, Bethesda, USA), an open-source platform for biological-image analysis.

      In a second test series in 10 stable HD patients, no blood sampling is performed but
      dialyzers are scanned post dialysis. The following different dialyzers in HD modus at midweek
      are tested:

        1. ATA™ Solacea 19H - HD - 1/1 anticoagulation

        2. ATA™ Solacea 19H - HD - 1/2 anticoagulation

        3. polysulfone FX800 - HD - 1/1 anticoagulation

        4. polysulfone FX800 - HD - 1/2 anticoagulation

        5. polysulfone FX800 - HD - 1/2 anticoagulation - with predialysis albmuin priming of the
           membrane

        6. Evodial - HD - no anticoagulation

        7. Evodial - HD - no anticoagulation - with predialysis albmuin priming of the membrane

      In a third test series in 10 stable HD patients, no blood sampling is performed but dialyzers
      are scanned post dialysis. The following different dialyzers at midweek are tested:

        1. ATA™ Solacea 19H - pre dilution HDF (substitution 150mL/min) - 1/4 anticoagulation

        2. ATA™ Solacea 19H - post dilution HDF (substitution 75mL/min) - 1/4 anticoagulation

        3. ATA™ Solacea 19H - HD - 1/4 anticoagulation

        4. ATA™ Solacea 19H - pre dilution HDF (substitution 150mL/min) - no anticoagulation

        5. ATA™ Solacea 19H - post dilution HDF (substitution 75mL/min) - no anticoagulation

        6. ATA™ Solacea 19H - HD - no anticoagulation

      First outcome measure: relative number of open fibers in each tested dialyzer. Second outcome
      measure: dialyzer performance (extraction ratio, adsorption).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of open fibres in the dialyzer
time frame: 17 weeks
description: Number of open fibres as assessed post dialysis by a reference microCT scanning technique
measure: Extraction ratio of three middle molecules in the dialyzer
time frame: 4 weeks
description: Extraction ratio from myoglobin, kappa and lambda free light chains as calculated from their concentrations at the dialyzer inlet en outlet
arm group label: Solacea_postHDF_1/1anticoagulation
arm group type: Experimental
description: intervention:
choice of dialyzer: Solacea dialyzer (Nipro, Japan)
choice of dialysis mode: post dilution hemodiafiltration
choice of anticoagulation strategy: standard anticoagulation dose
measurements:
blood & dialysate sampling at 60min after dialysis start
microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: Solacea_postHDF_1/2anticoagulation
arm group type: Experimental
description: intervention:
choice of dialyzer: Solacea dialyzer (Nipro Japan)
choice of dialysis mode: post dilution hemodiafiltration
choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose
measurements:
blood & dialysate sampling at 60min after dialysis start
microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: FX800_postHDF_1/1anticoagulation
arm group type: Experimental
description: intervention:
choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany)
choice of dialysis mode: post dilution hemodiafiltration
choice of anticoagulation strategy: standard anticoagulation dose
measurements:
blood & dialysate sampling at 60min after dialysis start
microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: FX800_postHDF_1/2anticoagulation
arm group type: Experimental
description: intervention:
choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany)
choice of dialysis mode: post dilution hemodiafiltration
choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose
measurements:
blood & dialysate sampling at 60min after dialysis start
microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: Solacea_HD_1/1anticoagulation
arm group type: Experimental
description: intervention:
choice of dialyzer: Solacea dialyzer (Nipro, Japan)
choice of dialysis mode: hemodialysis
choice of anticoagulation strategy: standard anticoagulation dose
measurement:
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: Solacea_HD_1/2anticoagulation
arm group type: Experimental
description: intervention:
choice of dialyzer: Solacea dialyzer (Nipro, Japan)
choice of dialysis mode: hemodialysis
choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose
measurements:
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: FX800_HD_1/1anticoagulation
arm group type: Experimental
description: intervention:
choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany)
choice of dialysis mode: hemodialysis
choice of anticoagulation strategy: standard anticoagulation dose
measurements:
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: FX800_HD_1/2anticoagulation
arm group type: Experimental
description: intervention:
choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany)
choice of dialysis mode: hemodialysis
choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose
measurements:
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: FX800_HD_1/2anticoagulation_albuprime
arm group type: Experimental
description: intervention:
choice of dialyzer: FX800 dialyzer (Fresenius Medical Care, Germany)
choice of dialysis mode: hemodialysis
choice of anticoagulation strategy: the patient receives only half of his/her standard anticoagulation dose
preparation of dialyzer: the dialyzer was preprimed with albumin solution
measurement:
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: Evodial_HD_no anticoagulation
arm group type: Experimental
description: intervention:
choice of dialyzer: Evodial 1.3 (Baxter, USA)
choice of dialysis mode: hemodialysis
choice of anticoagulation strategy: no anticoagulation is administered
measurement:
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: Evodial_HD_no anticoagulation_albuprime
arm group type: Experimental
description: intervention:
choice of dialyzer: Evodial 1.3 (Baxter, USA)
choice of dialysis mode: hemodialysis
choice of anticoagulation strategy: no anticoagulation is administered
preparation of dialyzer: the dialyzer was preprimed with albumin solution
measurement:
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: Solacea_preHDF_1/4anticoagulation
arm group type: Experimental
description: intervention:
choice of dialyzer: Solacea dialyzer (Nipro Japan)
choice of dialysis mode: pre dilution hemodiafiltration
choice of anticoagulation strategy: the patient receives only 1/4th of his/her standard anticoagulation dose
measurements:
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: Solacea_postHDF_1/4anticoagulation
arm group type: Experimental
description: intervention:
choice of dialyzer: Solacea dialyzer (Nipro Japan)
choice of dialysis mode: post dilution hemodiafiltration
choice of anticoagulation strategy: the patient receives only 1/4th of his/her standard anticoagulation dose
measurements:
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: Solacea_HD_1/4anticoagulation
arm group type: Experimental
description: intervention:
choice of dialyzer: Solacea dialyzer (Nipro Japan)
choice of dialysis mode: hemodialysis
choice of anticoagulation strategy: the patient receives only 1/4th of his/her standard anticoagulation dose
measurements:microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: Solacea_preHDF_no anticoagulation
arm group type: Experimental
description: intervention:
choice of dialyzer: Solacea dialyzer (Nipro Japan)
choice of dialysis mode: pre dilution hemodiafiltration
choice of anticoagulation strategy: no anticoagulation is administered
measurements:
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: Solacea_postHDF_no anticoagulation
arm group type: Experimental
description: intervention:
choice of dialyzer: Solacea dialyzer (Nipro Japan)
choice of dialysis mode: post dilution hemodiafiltration
choice of anticoagulation strategy: no anticoagulation is administered
measurements:
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
arm group label: Solacea_HD_no anticoagulation
arm group type: Experimental
description: intervention:
choice of dialyzer: Solacea dialyzer (Nipro Japan)
choice of dialysis mode: hemodialysis
choice of anticoagulation strategy: no anticoagulation is administered
measurements:
- microCT scanning of rinsed and dried dialyzer, post dialysis in order to count open fibers
intervention type: Device
intervention name: choice of dialyzer
description: Fiber blocking is calculated in different commercially available dialyzers
arm group label: Evodial_HD_no anticoagulation
arm group label: Evodial_HD_no anticoagulation_albuprime
arm group label: FX800_HD_1/1anticoagulation
arm group label: FX800_HD_1/2anticoagulation
arm group label: FX800_HD_1/2anticoagulation_albuprime
arm group label: FX800_postHDF_1/1anticoagulation
arm group label: FX800_postHDF_1/2anticoagulation
arm group label: Solacea_HD_1/1anticoagulation
arm group label: Solacea_HD_1/2anticoagulation
arm group label: Solacea_HD_1/4anticoagulation
arm group label: Solacea_HD_no anticoagulation
arm group label: Solacea_postHDF_1/1anticoagulation
arm group label: Solacea_postHDF_1/2anticoagulation
arm group label: Solacea_postHDF_1/4anticoagulation
arm group label: Solacea_postHDF_no anticoagulation
arm group label: Solacea_preHDF_1/4anticoagulation
arm group label: Solacea_preHDF_no anticoagulation
intervention type: Other
intervention name: choice of dialysis mode
description: Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
arm group label: Evodial_HD_no anticoagulation
arm group label: Evodial_HD_no anticoagulation_albuprime
arm group label: FX800_HD_1/1anticoagulation
arm group label: FX800_HD_1/2anticoagulation
arm group label: FX800_HD_1/2anticoagulation_albuprime
arm group label: FX800_postHDF_1/1anticoagulation
arm group label: FX800_postHDF_1/2anticoagulation
arm group label: Solacea_HD_1/1anticoagulation
arm group label: Solacea_HD_1/2anticoagulation
arm group label: Solacea_HD_1/4anticoagulation
arm group label: Solacea_HD_no anticoagulation
arm group label: Solacea_postHDF_1/1anticoagulation
arm group label: Solacea_postHDF_1/2anticoagulation
arm group label: Solacea_postHDF_1/4anticoagulation
arm group label: Solacea_postHDF_no anticoagulation
arm group label: Solacea_preHDF_1/4anticoagulation
arm group label: Solacea_preHDF_no anticoagulation
intervention type: Other
intervention name: choice of anticoagulation strategy
description: Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
arm group label: Evodial_HD_no anticoagulation
arm group label: Evodial_HD_no anticoagulation_albuprime
arm group label: FX800_HD_1/1anticoagulation
arm group label: FX800_HD_1/2anticoagulation
arm group label: FX800_HD_1/2anticoagulation_albuprime
arm group label: FX800_postHDF_1/1anticoagulation
arm group label: FX800_postHDF_1/2anticoagulation
arm group label: Solacea_HD_1/1anticoagulation
arm group label: Solacea_HD_1/2anticoagulation
arm group label: Solacea_HD_1/4anticoagulation
arm group label: Solacea_HD_no anticoagulation
arm group label: Solacea_postHDF_1/1anticoagulation
arm group label: Solacea_postHDF_1/2anticoagulation
arm group label: Solacea_postHDF_1/4anticoagulation
arm group label: Solacea_postHDF_no anticoagulation
arm group label: Solacea_preHDF_1/4anticoagulation
arm group label: Solacea_preHDF_no anticoagulation
intervention type: Other
intervention name: preparation of dialyzer
description: Fiber blocking is calculated in different commercially available dialyzers either preprimed with Albumin or not
arm group label: Evodial_HD_no anticoagulation_albuprime
arm group label: FX800_HD_1/2anticoagulation
arm group label: FX800_HD_1/2anticoagulation_albuprime
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
citation: Vanommeslaeghe F, Van Biesen W, Dierick M, Boone M, Dhondt A, Eloot S. Micro-computed tomography for the quantification of blocked fibers in hemodialyzers. Sci Rep. 2018 Feb 8;8(1):2677. doi: 10.1038/s41598-018-20898-w.
PMID: 29422614
responsible party type: Sponsor
sharing ipd: No