<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/NCT02977013</url>
  </required_header>
  <id_info>
    <org_study_id>MSAT-5</org_study_id>
    <nct_id>NCT02977013</nct_id>
  </id_info>
  <brief_title>Anti-Xa Assay Correlation to the Efficacy and Safety of Enoxaparin in the Treatment of Pulmonary Embolism</brief_title>
  <official_title>Anti-Xa Assay Correlation to the Efficacy and Safety of Enoxaparin in the Treatment of Pulmonary Embolism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mohamed Sayed Mohamed Abbas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Al Mouwasat Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study is to monitor anticoagulant therapy by anti-Xa assay and&#xD;
      correlate its level to the efficacy and safety of enoxaparin in the treatment of pulmonary&#xD;
      embolism.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective randomized trial was conducted on 42 patients 18 years of age or older in&#xD;
      ICU diagnosed to have pulmonary embolism and confirmed by the presence of intraluminal&#xD;
      filling defect in CT pulmonary angiography and treated with subcutaneous enoxaparin 1&#xD;
      mg/kg/12 hours. The study was conducted from August 2013 to September 2016.&#xD;
&#xD;
      All the patients were examined daily over a period of 4 weeks for symptoms and signs of&#xD;
      recurrent pulmonary embolism (recurrent pulmonary embolism was diagnosed if the repeat CT&#xD;
      angiography revealed a new sudden arterial branch cutoff or a new intraluminal filling defect&#xD;
      that was not present on the first angiogram), Platelet count (patients with platelet count&#xD;
      less than 50,000/mm3 or those with bleeding and platelet count between 50,000 and 100,000/mm3&#xD;
      are considered having severe thrombocytopenia), bleeding (defined as major overt bleeding&#xD;
      requiring blood transfusion &gt; 2 units or marked hemoglobin drop &gt; 2 gm/dl or if the bleeding&#xD;
      was intracranial or retroperitoneal) and death (defined as all deaths occurring within the 4&#xD;
      weeks of the study) , Then the results were correlated to anti-Xa assay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrent pulmonary embolism</measure>
    <time_frame>4 Weeks</time_frame>
    <description>Recurrent pulmonary embolism was diagnosed if the repeat CT angiography revealed a new sudden arterial branch cutoff or a new intraluminal filling defect that was not present on the first angiogram.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Platelet count</measure>
    <time_frame>4 Weeks</time_frame>
    <description>Patients with platelet count less than 50,000/mm3 or those with bleeding and platelet count between 50,000 and 100,000/mm3 are considered having severe thrombocytopenia</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Bleeding</measure>
    <time_frame>4 Weeks</time_frame>
    <description>Defined as major overt bleeding requiring blood transfusion &gt; 2 units or marked hemoglobin drop &gt; 2 gm/dl or if the bleeding was intracranial or retroperitoneal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Death</measure>
    <time_frame>4 Weeks</time_frame>
    <description>Defined as all deaths occurring within the 4 weeks of the study</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">42</enrollment>
  <condition>Anti-Xa Assay in Pulmonary Embolism</condition>
  <arm_group>
    <arm_group_label>Patients with pulmonary embolism treated with enoxaparin</arm_group_label>
    <description>Anti-Xa assay correlation to the efficacy and safety of enoxaparin in the treatment of pulmonary embolism</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Anti-Xa assay</intervention_name>
    <description>Correlation between anti-Xa assay and the efficacy and safety of enoxaparin in the treatment of pulmonary embolism</description>
    <arm_group_label>Patients with pulmonary embolism treated with enoxaparin</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study was conducted on 42 patients in ICU diagnosed to have pulmonary embolism by CT&#xD;
        pulmonary angiography and treated by subcutaneous enoxaparin 1 mg/kg every 12 hours.&#xD;
        Anticoagulant therapy was followed by anti-Xa assay done 4 hours after the third dose of&#xD;
        subcutaneous enoxaparin and the results were correlated to the clinical outcome of the&#xD;
        patients as regards complications (recurrent pulmonary embolism, bleeding, low platelet&#xD;
        count and death).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients in ICU and diagnosed to have pulmonary embolism and confirmed by the presence&#xD;
             of intraluminal filling defect in CT pulmonary angiography and treated with&#xD;
             subcutaneous enoxaparin 1 mg/kg/12 hours.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent thrombolysis, embolectomy or if they are unfit for&#xD;
             anticoagulant therapy because of major bleeding or thrombocytopenia (a platelet count&#xD;
             below 100,000 per cubic millimeter). Patients were also excluded if they had impaired&#xD;
             kidney function with a serum creatinine level above 2 mg/dl or uncontrolled&#xD;
             hypertension (blood pressure &gt; 160/100 mmHg).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>Montalescot G, Collet JP, Tanguy ML, Ankri A, Payot L, Dumaine R, Choussat R, Beygui F, Gallois V, Thomas D. Anti-Xa activity relates to survival and efficacy in unselected acute coronary syndrome patients treated with enoxaparin. Circulation. 2004 Jul 27;110(4):392-8. doi: 10.1161/01.CIR.0000136830.65073.C7. Epub 2004 Jul 12.</citation>
    <PMID>15249498</PMID>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>March 31, 2017</last_update_submitted>
  <last_update_submitted_qc>March 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Al Mouwasat Hospital</investigator_affiliation>
    <investigator_full_name>Mohamed Sayed Mohamed Abbas</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>Pulmonary Embolism</mesh_term>
    <mesh_term>Embolism</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin, Low-Molecular-Weight</mesh_term>
    <mesh_term>Dalteparin</mesh_term>
  </intervention_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/NCT02977013
org study id: MSAT-5
nct id: NCT02977013
lead sponsor: 
has dmc: No
The aim of the present study is to monitor anticoagulant therapy by anti-Xa assay and
      correlate its level to the efficacy and safety of enoxaparin in the treatment of pulmonary
      embolism.
This prospective randomized trial was conducted on 42 patients 18 years of age or older in
      ICU diagnosed to have pulmonary embolism and confirmed by the presence of intraluminal
      filling defect in CT pulmonary angiography and treated with subcutaneous enoxaparin 1
      mg/kg/12 hours. The study was conducted from August 2013 to September 2016.

      All the patients were examined daily over a period of 4 weeks for symptoms and signs of
      recurrent pulmonary embolism (recurrent pulmonary embolism was diagnosed if the repeat CT
      angiography revealed a new sudden arterial branch cutoff or a new intraluminal filling defect
      that was not present on the first angiogram), Platelet count (patients with platelet count
      less than 50,000/mm3 or those with bleeding and platelet count between 50,000 and 100,000/mm3
      are considered having severe thrombocytopenia), bleeding (defined as major overt bleeding
      requiring blood transfusion > 2 units or marked hemoglobin drop > 2 gm/dl or if the bleeding
      was intracranial or retroperitoneal) and death (defined as all deaths occurring within the 4
      weeks of the study) , Then the results were correlated to anti-Xa assay.
observational model: Case-Only
time perspective: Prospective
measure: Recurrent pulmonary embolism
time frame: 4 Weeks
description: Recurrent pulmonary embolism was diagnosed if the repeat CT angiography revealed a new sudden arterial branch cutoff or a new intraluminal filling defect that was not present on the first angiogram.
measure: Platelet count
time frame: 4 Weeks
description: Patients with platelet count less than 50,000/mm3 or those with bleeding and platelet count between 50,000 and 100,000/mm3 are considered having severe thrombocytopenia
measure: Bleeding
time frame: 4 Weeks
description: Defined as major overt bleeding requiring blood transfusion > 2 units or marked hemoglobin drop > 2 gm/dl or if the bleeding was intracranial or retroperitoneal
measure: Death
time frame: 4 Weeks
description: Defined as all deaths occurring within the 4 weeks of the study
arm group label: Patients with pulmonary embolism treated with enoxaparin
description: Anti-Xa assay correlation to the efficacy and safety of enoxaparin in the treatment of pulmonary embolism
intervention type: Diagnostic Test
intervention name: Anti-Xa assay
description: Correlation between anti-Xa assay and the efficacy and safety of enoxaparin in the treatment of pulmonary embolism
arm group label: Patients with pulmonary embolism treated with enoxaparin
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
citation: Montalescot G, Collet JP, Tanguy ML, Ankri A, Payot L, Dumaine R, Choussat R, Beygui F, Gallois V, Thomas D. Anti-Xa activity relates to survival and efficacy in unselected acute coronary syndrome patients treated with enoxaparin. Circulation. 2004 Jul 27;110(4):392-8. doi: 10.1161/01.CIR.0000136830.65073.C7. Epub 2004 Jul 12.
PMID: 15249498
responsible party type: Sponsor-Investigator
investigator affiliation: Al Mouwasat Hospital
investigator full name: Mohamed Sayed Mohamed Abbas
investigator title: Doctor
mesh term: Pulmonary Embolism
mesh term: Embolism
mesh term: Heparin, Low-Molecular-Weight
mesh term: Dalteparin