<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/NCT03762707</url>
  </required_header>
  <id_info>
    <org_study_id>LGPFA100</org_study_id>
    <nct_id>NCT03762707</nct_id>
  </id_info>
  <brief_title>Correlation Between Platelet Function Analyzer-100 Testing and Bleeding Events After Percutaneous Kidney Biopsy</brief_title>
  <official_title>Correlation Between Platelet Function Analyzer-100 Testing and Bleeding Events After Percutaneous Kidney Biopsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Prof. Carlo Manno</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dott. Francesco Pesce</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dott. Michele Rossini</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dott. Vincenzo Di Leo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari</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>
      Kidney biopsy represents the criterion standard to obtain information on diagnosis and&#xD;
      prognosis of renal dysfunctions . Many patients with kidney disease have a predisposition to&#xD;
      bleed, especially when they undergo an invasive procedure such as renal biopsy. The&#xD;
      predominant factor is abnormal platelet function. Therefore, the aim of this study is to&#xD;
      evaluate whether the platelet function analyzer (PFA-100), a very reliable test to&#xD;
      investigate primary hemostasis, can be useful in predicting the risk of bleeding&#xD;
      complications in patients undergoing renal biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Kidney biopsy frequently is used to investigate the cause of suspected renal parenchymal&#xD;
      disease. Although kidney biopsy may provide important diagnostic information and guide&#xD;
      therapeutic decisions, the benefits must be weighed against the potential harms of biopsy.&#xD;
      Bleeding is one of the most feared risks from a renal biopsy.&#xD;
&#xD;
      The technique has significantly evolved because of the introduction of real-time ultrasound&#xD;
      guidance and use an automated spring-loaded biopsy device. As a consequence, the general&#xD;
      safety and complication rate of the procedure has substantially improved. Post biopsy&#xD;
      bleeding (hematoma and hematuria) is the primary complication of renal biopsies. However,&#xD;
      most of the perirenal hematomas are minor and without clinical significance, and major&#xD;
      complications are infrequent.&#xD;
&#xD;
      To minimize bleeding risk, we used the following prebiopsy parameters as a guide: prothrombin&#xD;
      time (PT), activated partial thromboplastin time (aPTT), platelet count, age, sex, glomerular&#xD;
      filtration rate and blood pressure. Antiaggregant and anticoagulant were stopped for 7 -10&#xD;
      days before biopsy. The Ivy bleeding time (BT) was performed.&#xD;
&#xD;
      Although an specific lancet is used to deliver a relatively standardized incision on the&#xD;
      patient's forearm, the Ivy bleeding time technique is patient and operator-dependent. Skin&#xD;
      thickness varies not only with age, but also with a number of other factors, such as&#xD;
      nutritional status. For these reasons was developed the platelet function analyzer, PFA-100.&#xD;
      This test assess primary haemostasis in vitro using citrated whole blood. The device&#xD;
      simulates in vivo haemostatic plug formation under high shear flow by measuring the time&#xD;
      required to occlude (closure time, CT) a collagen/epinephrine (Coll-EPI) or collagen/ADP&#xD;
      (Coll-ADP)-coated aperture inserted in a plastic membrane. PFA-100 is more sensitive than BT&#xD;
      to abnormalities of primary haemostasis.&#xD;
&#xD;
      The objective of this study is to demonstrate whether an abnormal PFA-100 can predict&#xD;
      bleeding events after percutaneous kidney biopsy.&#xD;
&#xD;
      The present cohort includes 250 all adult patients who underwent percutaneous renal biopsy of&#xD;
      native kidney in the Department of Emergency and Organ Transplantation, the University of&#xD;
      Bari, Italy, from January 2017 to December 2018. Transplant kidney biopsies were excluded&#xD;
      from this study. Three experienced nephrologists performed all the biopsies.&#xD;
&#xD;
      Participation included clinical data collection, serial blood and urine sampling before and&#xD;
      after the procedure. Kidney ultrasound was performed in all patients before the procedure.&#xD;
&#xD;
      The following data were collected for all patients:&#xD;
&#xD;
        -  Variables pre-biopsy:&#xD;
&#xD;
             -  baseline demographics (age, gender);&#xD;
&#xD;
             -  indication for renal biopsy [urinary abnormalities (i.e., proteinuria and&#xD;
                haematuria), and/or recurrent macrohaematuria and/or nephrotic syndrome and/or&#xD;
                nephritic syndrome and/or alteration of renal function and/or acute renal failure];&#xD;
&#xD;
             -  baseline systolic and diastolic blood pressure;&#xD;
&#xD;
             -  which kidney was biopsied;&#xD;
&#xD;
             -  baseline serum creatinine, azotaemia and glomerular filtration rate;&#xD;
&#xD;
             -  baseline haemoglobin and platelet count;&#xD;
&#xD;
             -  baseline coagulation parameters (prothrombin time, partial thromboplastin time,&#xD;
                bleeding time);&#xD;
&#xD;
             -  baseline urinary protein excretion;&#xD;
&#xD;
             -  body mass index.&#xD;
&#xD;
        -  Variables during-biopsy:&#xD;
&#xD;
             -  administration of DDAVP;&#xD;
&#xD;
             -  number of passes;&#xD;
&#xD;
             -  number of renal biopsy samples;&#xD;
&#xD;
             -  the position of the patient during kidney biopsy [prone position or supine&#xD;
                anterolateral position (SALP)];&#xD;
&#xD;
        -  Variables post-biopsy:&#xD;
&#xD;
             -  hemoglobin;&#xD;
&#xD;
             -  post-biopsy bleeding complications (gross hematuria, hematoma);&#xD;
&#xD;
             -  if was necessary transfusion of blood products or an invasive procedure&#xD;
                (angiography and arterial embolization or surgery).&#xD;
&#xD;
      Evaluation of kidneys conditions were performed by ultrasound before the procedure in all&#xD;
      patients. Longitudinal and transverse size, corticomedullary differentiation shape, location&#xD;
      and related structures of the kidney were assessed using ultrasound and blood flow of the&#xD;
      kidneys were assessed using a color-flow Doppler signal.&#xD;
&#xD;
      All biopsies were performed using real-time ultrasound-fixed guidance by a nephrologist with&#xD;
      assistance from an expert in renal ultrasonography. A 16-gauge automated spring-loaded gun&#xD;
      was used for the biopsy. A pathologist promptly examined the biopsy specimen under alight&#xD;
      microscope to confirm that adequate renal tissue was available for further pathological&#xD;
      evaluations. 1-deamino-8-D-arginine vasopressin (DDAVP) was administered to all patients who&#xD;
      had not contraindication.&#xD;
&#xD;
      After the procedure, patients were invited to rest in bed on their backs for a 24-hour&#xD;
      observation time. Meantime, clinical evaluation (gross haematuria, flank pain, hypotension)&#xD;
      was performed to identify a bleeding complications. Ultrasound evaluation was performed for&#xD;
      all patients after 24 hours from percutaneous renal biopsy to exclude a presence of&#xD;
      complication, as hematoma and arteriovenous fistula Post biopsy bleeding complications were&#xD;
      categorized as either minor or major. Minor bleeding complications included gross haematuria&#xD;
      and/or subcapsular perinephric hematoma (&lt;5cm diameter) that spontaneously resolved without&#xD;
      need for further intervention. Major complications were defined as those that required an&#xD;
      intervention for resolution, either the transfusion of blood products or an invasive&#xD;
      procedure (angiography, surgery), and those that led to acute renal obstruction or failure,&#xD;
      septicaemia, or death. The size of post biopsy hematoma (surface area) was defined as the&#xD;
      product of the longest and the shortest diameters on the two-dimensional sonographic&#xD;
      pictures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 13, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Bleeding After Kidney Biopsy</measure>
    <time_frame>24 hours</time_frame>
    <description>Gross haematuria and/or subcapsular perinephric hematoma at ultrasound evaluation. Need for transfusion of blood products or an invasive procedure (angiography, surgery).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin After Kidney Biopsy</measure>
    <time_frame>24 hours</time_frame>
    <description>Anemization After Kidney Biopsy</description>
  </secondary_outcome>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Blood Platelet Disorder</condition>
  <condition>Hemorrhage</condition>
  <condition>Kidney Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The present cohort includes 250 all adult patients who underwent percutaneous renal biopsy&#xD;
        of native kidney in the Department of Emergency and Organ Transplantation, the University&#xD;
        of Bari, Italy, from January 2017 to December 2018. Transplant kidney biopsies were&#xD;
        excluded from this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients undergoing standard percutaneous renal biopsy performed in our Unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication to standard percutaneous renal biopsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>Vincenzo Di Leo, Dr</last_name>
    <phone>+ 39 3332989599</phone>
    <email>vincenzodileo88@yahoo.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>AOUConsorziale Policlinico Di Bari</name>
      <address>
        <city>Bari</city>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Loreto Gesualdo, Prof</last_name>
      <phone>+390805594040</phone>
      <email>trialnefrobari@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 2, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>June 14, 2019</last_update_submitted>
  <last_update_submitted_qc>June 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari</investigator_affiliation>
    <investigator_full_name>Loreto GESUALDO</investigator_full_name>
    <investigator_title>Full Professor of Nephrology</investigator_title>
  </responsible_party>
  <keyword>Platelet Function Analyser-100 (PFA-100)</keyword>
  <keyword>Kidney biopsy</keyword>
  <keyword>Bleeding Complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Blood Platelet Disorders</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <!-- 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/NCT03762707
org study id: LGPFA100
nct id: NCT03762707
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Kidney biopsy represents the criterion standard to obtain information on diagnosis and
      prognosis of renal dysfunctions . Many patients with kidney disease have a predisposition to
      bleed, especially when they undergo an invasive procedure such as renal biopsy. The
      predominant factor is abnormal platelet function. Therefore, the aim of this study is to
      evaluate whether the platelet function analyzer (PFA-100), a very reliable test to
      investigate primary hemostasis, can be useful in predicting the risk of bleeding
      complications in patients undergoing renal biopsy.
Kidney biopsy frequently is used to investigate the cause of suspected renal parenchymal
      disease. Although kidney biopsy may provide important diagnostic information and guide
      therapeutic decisions, the benefits must be weighed against the potential harms of biopsy.
      Bleeding is one of the most feared risks from a renal biopsy.

      The technique has significantly evolved because of the introduction of real-time ultrasound
      guidance and use an automated spring-loaded biopsy device. As a consequence, the general
      safety and complication rate of the procedure has substantially improved. Post biopsy
      bleeding (hematoma and hematuria) is the primary complication of renal biopsies. However,
      most of the perirenal hematomas are minor and without clinical significance, and major
      complications are infrequent.

      To minimize bleeding risk, we used the following prebiopsy parameters as a guide: prothrombin
      time (PT), activated partial thromboplastin time (aPTT), platelet count, age, sex, glomerular
      filtration rate and blood pressure. Antiaggregant and anticoagulant were stopped for 7 -10
      days before biopsy. The Ivy bleeding time (BT) was performed.

      Although an specific lancet is used to deliver a relatively standardized incision on the
      patient's forearm, the Ivy bleeding time technique is patient and operator-dependent. Skin
      thickness varies not only with age, but also with a number of other factors, such as
      nutritional status. For these reasons was developed the platelet function analyzer, PFA-100.
      This test assess primary haemostasis in vitro using citrated whole blood. The device
      simulates in vivo haemostatic plug formation under high shear flow by measuring the time
      required to occlude (closure time, CT) a collagen/epinephrine (Coll-EPI) or collagen/ADP
      (Coll-ADP)-coated aperture inserted in a plastic membrane. PFA-100 is more sensitive than BT
      to abnormalities of primary haemostasis.

      The objective of this study is to demonstrate whether an abnormal PFA-100 can predict
      bleeding events after percutaneous kidney biopsy.

      The present cohort includes 250 all adult patients who underwent percutaneous renal biopsy of
      native kidney in the Department of Emergency and Organ Transplantation, the University of
      Bari, Italy, from January 2017 to December 2018. Transplant kidney biopsies were excluded
      from this study. Three experienced nephrologists performed all the biopsies.

      Participation included clinical data collection, serial blood and urine sampling before and
      after the procedure. Kidney ultrasound was performed in all patients before the procedure.

      The following data were collected for all patients:

        -  Variables pre-biopsy:

             -  baseline demographics (age, gender);

             -  indication for renal biopsy [urinary abnormalities (i.e., proteinuria and
                haematuria), and/or recurrent macrohaematuria and/or nephrotic syndrome and/or
                nephritic syndrome and/or alteration of renal function and/or acute renal failure];

             -  baseline systolic and diastolic blood pressure;

             -  which kidney was biopsied;

             -  baseline serum creatinine, azotaemia and glomerular filtration rate;

             -  baseline haemoglobin and platelet count;

             -  baseline coagulation parameters (prothrombin time, partial thromboplastin time,
                bleeding time);

             -  baseline urinary protein excretion;

             -  body mass index.

        -  Variables during-biopsy:

             -  administration of DDAVP;

             -  number of passes;

             -  number of renal biopsy samples;

             -  the position of the patient during kidney biopsy [prone position or supine
                anterolateral position (SALP)];

        -  Variables post-biopsy:

             -  hemoglobin;

             -  post-biopsy bleeding complications (gross hematuria, hematoma);

             -  if was necessary transfusion of blood products or an invasive procedure
                (angiography and arterial embolization or surgery).

      Evaluation of kidneys conditions were performed by ultrasound before the procedure in all
      patients. Longitudinal and transverse size, corticomedullary differentiation shape, location
      and related structures of the kidney were assessed using ultrasound and blood flow of the
      kidneys were assessed using a color-flow Doppler signal.

      All biopsies were performed using real-time ultrasound-fixed guidance by a nephrologist with
      assistance from an expert in renal ultrasonography. A 16-gauge automated spring-loaded gun
      was used for the biopsy. A pathologist promptly examined the biopsy specimen under alight
      microscope to confirm that adequate renal tissue was available for further pathological
      evaluations. 1-deamino-8-D-arginine vasopressin (DDAVP) was administered to all patients who
      had not contraindication.

      After the procedure, patients were invited to rest in bed on their backs for a 24-hour
      observation time. Meantime, clinical evaluation (gross haematuria, flank pain, hypotension)
      was performed to identify a bleeding complications. Ultrasound evaluation was performed for
      all patients after 24 hours from percutaneous renal biopsy to exclude a presence of
      complication, as hematoma and arteriovenous fistula Post biopsy bleeding complications were
      categorized as either minor or major. Minor bleeding complications included gross haematuria
      and/or subcapsular perinephric hematoma (<5cm diameter) that spontaneously resolved without
      need for further intervention. Major complications were defined as those that required an
      intervention for resolution, either the transfusion of blood products or an invasive
      procedure (angiography, surgery), and those that led to acute renal obstruction or failure,
      septicaemia, or death. The size of post biopsy hematoma (surface area) was defined as the
      product of the longest and the shortest diameters on the two-dimensional sonographic
      pictures.
observational model: Cohort
time perspective: Retrospective
measure: Bleeding After Kidney Biopsy
time frame: 24 hours
description: Gross haematuria and/or subcapsular perinephric hematoma at ultrasound evaluation. Need for transfusion of blood products or an invasive procedure (angiography, surgery).
measure: Hemoglobin After Kidney Biopsy
time frame: 24 hours
description: Anemization After Kidney Biopsy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
last name: Vincenzo Di Leo, Dr
phone: + 39 3332989599
email: vincenzodileo88@yahoo.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
investigator full name: Loreto GESUALDO
investigator title: Full Professor of Nephrology
mesh term: Kidney Diseases
mesh term: Blood Platelet Disorders
mesh term: Hemorrhage