<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/NCT03007017</url>
  </required_header>
  <id_info>
    <org_study_id>00071879</org_study_id>
    <nct_id>NCT03007017</nct_id>
  </id_info>
  <brief_title>Novel Strategies for Innovating Deceased Donor Procurement</brief_title>
  <official_title>Novel Strategies for Innovating Deceased Donor Procurement</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Maryland, Baltimore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Living Legacy Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Maryland, Baltimore</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite many efforts to increase the size of the donor pool, there is a large and growing&#xD;
      disparity between the number of donor kidneys available for transplantation and the number of&#xD;
      patients on the transplant waiting list. Increasing the quality of currently available donor&#xD;
      kidneys would potentially improve the longevity of deceased donor kidney transplants by&#xD;
      years, thus increasing the rate of transplantation patients on the kidney transplant waiting&#xD;
      list. In addition, recipients of higher quality kidneys have shorter hospital stays and lower&#xD;
      total hospital charges. By innovating the organ donation process, such that deceased donor&#xD;
      kidneys are removed prior to the cessation of cardiac activity, rather than after, it may be&#xD;
      possible to improve the quality of the kidney before transplantation, resulting in improved&#xD;
      function after transplantation and increased longevity of these transplanted kidneys.&#xD;
      Further, this improved kidney quality is highly likely to translate to reduced need for renal&#xD;
      dialysis and other high-cost interventions, yielding lower total hospital charges. In this&#xD;
      study we will test the hypothesis that, through a cost-free technical innovation, the quality&#xD;
      of deceased donor kidneys could be improved significantly, saving thousands more lives per&#xD;
      year and reducing total health care expenditures on renal transplantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 7, 2021</completion_date>
  <primary_completion_date type="Actual">June 7, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sequence of organ procurement</measure>
    <time_frame>1 year</time_frame>
    <description>Renal allograft survival</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Kidney quality</measure>
    <time_frame>3 months</time_frame>
    <description>Incidence of delayed renal graft function</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Kidney Failure, Chronic</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients selected for this arm will receive the left kidney from the new method of organ retrieval.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients selected for this arm will receive the normal standard of care operational kidney from retrieval.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Deceased donor nephrectomy, prior to cross clamp of donor aorta</intervention_name>
    <description>The investigators will perform a prospective investigation of organ recoveries during which the left kidney will be removed prior to cessation of cardiac activity. The second kidney will be removed in the standard fashion. To do this, investigators will adopt techniques used in living donor kidney transplantation. Specifically, a specialized vascular stapler will be used to divide the renal artery at the level of aorta, followed by the vein, at the level of the vena cava. As such, no &quot;cuff&quot; of abdominal aorta or vena cava will be present on the target kidneys. Once removed from the body, just as is done for living donor kidney transplantation, the kidneys will be immediately flushed. As this ex-vivo flush is already performed for cadaveric kidney transplantation, there should be no additional cost for performing this portion of the procedure. Approximately 15 minutes of additional surgical dissection (prior to stopping the heart) will be required under the proposed study.</description>
    <arm_group_label>Arm 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Deceased donor nephrectomy, standard of care</intervention_name>
    <description>The investigators will remove the right kidney in the stand of care procedures for cadaveric kidney transplantation</description>
    <arm_group_label>Arm 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Currently listed to receive a deceased donor kidney transplant&#xD;
&#xD;
          2. Able to fully understand the informed consent document&#xD;
&#xD;
          3. Recipient over the age of 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Recipients undergoing a bilateral native nephrectomy at time of transplant&#xD;
&#xD;
          2. Recipients undergoing dual (liver-kidney, kidney-pancreas, pediatric en bloc)&#xD;
             transplant&#xD;
&#xD;
          3. Individuals who are unable to understand the informed consent document&#xD;
&#xD;
          4. Recipient under age 18 years&#xD;
&#xD;
          5. Recipients receiving desensitization protocols for high levels of donor specific&#xD;
             antibodies&#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>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>June 7, 2021</last_update_submitted>
  <last_update_submitted_qc>June 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Maryland, Baltimore</investigator_affiliation>
    <investigator_full_name>Joseph Scalea</investigator_full_name>
    <investigator_title>Assistant Professor of Surgery Director of Pancreas and Islet Cell Transplantation</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Kidney Failure, Chronic</mesh_term>
  </condition_browse>
  <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/NCT03007017
org study id: 00071879
nct id: NCT03007017
lead sponsor: 
collaborator: 
has dmc: Yes
Despite many efforts to increase the size of the donor pool, there is a large and growing
      disparity between the number of donor kidneys available for transplantation and the number of
      patients on the transplant waiting list. Increasing the quality of currently available donor
      kidneys would potentially improve the longevity of deceased donor kidney transplants by
      years, thus increasing the rate of transplantation patients on the kidney transplant waiting
      list. In addition, recipients of higher quality kidneys have shorter hospital stays and lower
      total hospital charges. By innovating the organ donation process, such that deceased donor
      kidneys are removed prior to the cessation of cardiac activity, rather than after, it may be
      possible to improve the quality of the kidney before transplantation, resulting in improved
      function after transplantation and increased longevity of these transplanted kidneys.
      Further, this improved kidney quality is highly likely to translate to reduced need for renal
      dialysis and other high-cost interventions, yielding lower total hospital charges. In this
      study we will test the hypothesis that, through a cost-free technical innovation, the quality
      of deceased donor kidneys could be improved significantly, saving thousands more lives per
      year and reducing total health care expenditures on renal transplantation.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Sequence of organ procurement
time frame: 1 year
description: Renal allograft survival
measure: Kidney quality
time frame: 3 months
description: Incidence of delayed renal graft function
arm group label: Arm 1
arm group type: Experimental
description: Patients selected for this arm will receive the left kidney from the new method of organ retrieval.
arm group label: Arm 2
arm group type: Active Comparator
description: Patients selected for this arm will receive the normal standard of care operational kidney from retrieval.
intervention type: Procedure
intervention name: Deceased donor nephrectomy, prior to cross clamp of donor aorta
description: The investigators will perform a prospective investigation of organ recoveries during which the left kidney will be removed prior to cessation of cardiac activity. The second kidney will be removed in the standard fashion. To do this, investigators will adopt techniques used in living donor kidney transplantation. Specifically, a specialized vascular stapler will be used to divide the renal artery at the level of aorta, followed by the vein, at the level of the vena cava. As such, no "cuff" of abdominal aorta or vena cava will be present on the target kidneys. Once removed from the body, just as is done for living donor kidney transplantation, the kidneys will be immediately flushed. As this ex-vivo flush is already performed for cadaveric kidney transplantation, there should be no additional cost for performing this portion of the procedure. Approximately 15 minutes of additional surgical dissection (prior to stopping the heart) will be required under the proposed study.
arm group label: Arm 1
intervention type: Procedure
intervention name: Deceased donor nephrectomy, standard of care
description: The investigators will remove the right kidney in the stand of care procedures for cadaveric kidney transplantation
arm group label: Arm 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Maryland, Baltimore
investigator full name: Joseph Scalea
investigator title: Assistant Professor of Surgery Director of Pancreas and Islet Cell Transplantation
mesh term: Renal Insufficiency
mesh term: Kidney Failure, Chronic
sharing ipd: No