<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/NCT03232359</url>
  </required_header>
  <id_info>
    <org_study_id>AAMABDELKADER 3</org_study_id>
    <nct_id>NCT03232359</nct_id>
  </id_info>
  <brief_title>Immature Platelet Fraction as a Promising Biomarker in Prediction Outcome of HELLP Syndrome</brief_title>
  <official_title>Assessment of Immature Platelet Fraction in Pregnancy-Associated Thrombotic Microangiopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AYMAN ABDELKADER MOHAMED ABDELKADER</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams Maternity Hospital</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>
      Immature platelet fraction is a non-invasive test of real time thrombopoiesis. High IPF% has&#xD;
      been suggested as an indicator of thrombocytopenia due to rapid platelet consumption. IPF% is&#xD;
      able to discriminate between patients with TTP/HUS or SPE/HELLP&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thrombotic microangiopathy (TMA) syndromes are extraordinarily diverse. Thrombotic&#xD;
      thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS) are the two most well&#xD;
      known, and are considered to be the most serious. TTP-HUS occurs more commonly in women and&#xD;
      among women is commonly associated with pregnancy.&#xD;
&#xD;
      Nevertheless, there are other pregnancy conditions that may manifest with TMA, including&#xD;
      preeclampsia, eclampsia, HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet&#xD;
      count), in addition to acute fatty liver of pregnancy, antiphospholipid syndrome, and&#xD;
      systemic lupus erythematosis.&#xD;
&#xD;
      Assessment of immature platelets was introduced as a non-invasive test of real time&#xD;
      thrombopoiesis. They are newly released in the circulation with a larger size &amp; greater RNA&#xD;
      content than mature platelets, and can be measured by automated haematology analyzer equipped&#xD;
      with reticulocyte detection channel and described as immature platelet fraction (%-IPF) and&#xD;
      immature platelet count (A-IPC).&#xD;
&#xD;
      A high %-IPF has been suggested as an indicator of thrombocytopenia due to rapid platelet&#xD;
      consumption, while a low %-IPF is characteristic of bone marrow suppression states.&#xD;
      %-IPF/A-IPF has the competency to be performed routinely and, therefore, can provide&#xD;
      therapeutic and diagnostic feedback in the life threatening conditions.&#xD;
&#xD;
      The present study aimed to show the utility of estimating %-IPF and A-IPC using a&#xD;
      reticulocyte detection channel CBC autoanalyzer as a simple reproducible blood analysis to be&#xD;
      employed in the differential diagnosis of pregnancy-associated thrombotic microangiopathic&#xD;
      conditions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">June 1, 2016</completion_date>
  <primary_completion_date type="Actual">December 1, 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Weeks</target_duration>
  <primary_outcome>
    <measure>clinical response after delivery</measure>
    <time_frame>48 hours after delivery</time_frame>
    <description>clinical and laboratory changes after delivery</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">57</enrollment>
  <condition>Pre-Eclampsia, Severe</condition>
  <condition>HELLP Syndrome</condition>
  <condition>Microangiopathy</condition>
  <arm_group>
    <arm_group_label>SPE/HELLP group</arm_group_label>
    <description>This group included 24 pregnant women (gestational age of &gt;20 weeks) who were diagnosed as having TMA with provisional diagnosis of pre-eclampsia, HELLP syndrome. immature platelets fraction assessment within 12 hours of diagnosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TTP/HUS group</arm_group_label>
    <description>This group included 13 pregnant women (gestational age of &gt;20 weeks) who were diagnosed as having TMA with provisional diagnosis of TTP/HUS. HELLP syndrome. immature platelets fraction assessment within 12 hours of diagnosis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>This group included 20 pregnant women (gestational age of &gt;20 weeks) having normal pregnancy with normal blood pressure and platelet count.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>immature platelets fraction</intervention_name>
    <description>IPF-% and A-IPC using a reticulocyte detection channel CBC auto analyzer</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>SPE/HELLP group</arm_group_label>
    <arm_group_label>TTP/HUS group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Group 1: SPE/HELLP group. This group included 24 pregnant women (gestational age of &gt;20&#xD;
        weeks) who were diagnosed as having TMA with provisional diagnosis of pre-eclampsia, HELLP&#xD;
        syndrome.&#xD;
&#xD;
        Group 2: TTP/HUS group. This group included 13 pregnant women (gestational age of &gt;20&#xD;
        weeks) who were diagnosed as having TMA with provisional diagnosis of TTP/HUS.&#xD;
&#xD;
        Group 3: Control group. This group included 20 pregnant women (gestational age of &gt;20&#xD;
        weeks) having normal pregnancy with normal blood pressure and platelet count.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Older than 20 years of age&#xD;
&#xD;
          -  Pregnant with singleton intrauterine pregnancy&#xD;
&#xD;
          -  More than 20 weeks of gestation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congenital malformation and fetuses with chromosomal or genetic syndrome.&#xD;
&#xD;
          -  Recent blood transfusion.&#xD;
&#xD;
          -  Refusal to participate in the study.&#xD;
&#xD;
          -  BMI &lt;18.&#xD;
&#xD;
          -  Placental abnormalities like velamentous insertion.&#xD;
&#xD;
          -  Multiple pregnancies.&#xD;
&#xD;
          -  Known kidney disease.&#xD;
&#xD;
          -  History of auto immune disease.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams Maternity Hospital</investigator_affiliation>
    <investigator_full_name>AYMAN ABDELKADER MOHAMED ABDELKADER</investigator_full_name>
    <investigator_title>doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Eclampsia</mesh_term>
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>HELLP Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 1, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03232359/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 1, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/59/NCT03232359/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03232359
org study id: AAMABDELKADER 3
nct id: NCT03232359
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Immature platelet fraction is a non-invasive test of real time thrombopoiesis. High IPF% has
      been suggested as an indicator of thrombocytopenia due to rapid platelet consumption. IPF% is
      able to discriminate between patients with TTP/HUS or SPE/HELLP
Thrombotic microangiopathy (TMA) syndromes are extraordinarily diverse. Thrombotic
      thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS) are the two most well
      known, and are considered to be the most serious. TTP-HUS occurs more commonly in women and
      among women is commonly associated with pregnancy.

      Nevertheless, there are other pregnancy conditions that may manifest with TMA, including
      preeclampsia, eclampsia, HELLP syndrome (hemolysis, elevated liver enzymes, and low platelet
      count), in addition to acute fatty liver of pregnancy, antiphospholipid syndrome, and
      systemic lupus erythematosis.

      Assessment of immature platelets was introduced as a non-invasive test of real time
      thrombopoiesis. They are newly released in the circulation with a larger size & greater RNA
      content than mature platelets, and can be measured by automated haematology analyzer equipped
      with reticulocyte detection channel and described as immature platelet fraction (%-IPF) and
      immature platelet count (A-IPC).

      A high %-IPF has been suggested as an indicator of thrombocytopenia due to rapid platelet
      consumption, while a low %-IPF is characteristic of bone marrow suppression states.
      %-IPF/A-IPF has the competency to be performed routinely and, therefore, can provide
      therapeutic and diagnostic feedback in the life threatening conditions.

      The present study aimed to show the utility of estimating %-IPF and A-IPC using a
      reticulocyte detection channel CBC autoanalyzer as a simple reproducible blood analysis to be
      employed in the differential diagnosis of pregnancy-associated thrombotic microangiopathic
      conditions.
observational model: Cohort
time perspective: Prospective
measure: clinical response after delivery
time frame: 48 hours after delivery
description: clinical and laboratory changes after delivery
arm group label: SPE/HELLP group
description: This group included 24 pregnant women (gestational age of >20 weeks) who were diagnosed as having TMA with provisional diagnosis of pre-eclampsia, HELLP syndrome. immature platelets fraction assessment within 12 hours of diagnosis
arm group label: TTP/HUS group
description: This group included 13 pregnant women (gestational age of >20 weeks) who were diagnosed as having TMA with provisional diagnosis of TTP/HUS. HELLP syndrome. immature platelets fraction assessment within 12 hours of diagnosis
arm group label: Control group
description: This group included 20 pregnant women (gestational age of >20 weeks) having normal pregnancy with normal blood pressure and platelet count.
intervention type: Diagnostic Test
intervention name: immature platelets fraction
description: IPF-% and A-IPC using a reticulocyte detection channel CBC auto analyzer
arm group label: Control group
arm group label: SPE/HELLP group
arm group label: TTP/HUS group
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams Maternity Hospital
investigator full name: AYMAN ABDELKADER MOHAMED ABDELKADER
investigator title: doctor
mesh term: Eclampsia
mesh term: Pre-Eclampsia
mesh term: HELLP Syndrome
mesh term: Syndrome
sharing ipd: No
provided document: 
provided document: 