xml: <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/NCT06020560</url>
    </required_header>
    <id_info>
      <org_study_id>DANHEP</org_study_id>
      <nct_id>NCT06020560</nct_id>
    </id_info>
    <brief_title>Study of Low Molecular Weight Heparins</brief_title>
    <acronym>DANHEP</acronym>
    <official_title>Cluster-randomized Trial of Low Molecular Weight Heparins - Directly Through EPIC</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Herlev Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Herlev Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        DANHEP is a cluster randomized study of two different low molecular weight heparins.&#xD;
        Parenteral anticoagulants are used in a variety of settings, including treatment and&#xD;
        prevention of venous thromboembolism in cancer patients, medical patients, and surgical&#xD;
        patients, along with the use as adjuvant therapy for coronary syndromes. The most frequently&#xD;
        used parenteral anticoagulants in Denmark, include the two different low molecular weight&#xD;
        heparins; dalteparin and tinzaparin. The two drugs are considered equally efficient and safe&#xD;
        regarding treatment and prevention of thrombosis and risk of bleeding. Importantly, there is&#xD;
        a lack of evidence regarding whether these drugs are in fact comparable. The aim of this&#xD;
        study is therefore to investigate the comparative safety and efficacy of the two different&#xD;
        low molecular weight heparins (dalteparin and tinzaparin using cluster randomization in&#xD;
        patients with an indication for low molecular weight heparins.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 23, 2023</start_date>
    <completion_date type="Anticipated">March 23, 2025</completion_date>
    <primary_completion_date type="Anticipated">March 23, 2025</primary_completion_date>
    <phase>Phase 4</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>30-day all-cause mortality and bleeding requiring blood transfusion</measure>
      <time_frame>30 days</time_frame>
      <description>To evaluate whether treatment with any of the low molecular weight heparins will increase the risk of bleeding requiring blood transfusion during admission or death within 30 days in patients with indication for low molecular weight heparins.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>30-day all-cause mortality</measure>
      <time_frame>30 days</time_frame>
      <description>Risk of all-cause mortality within 30 days of administering one of the studied drugs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>365-day all-cause mortality</measure>
      <time_frame>365 days</time_frame>
      <description>Risk of all-cause mortality within 365 days of administering one of the studied drugs</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood transfusion during admission</measure>
      <time_frame>90 days</time_frame>
      <description>Blood transfusion defined from use of blood products</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>90 day risk of pulmonary embolism</measure>
      <time_frame>90 days</time_frame>
      <description>Risk of pulmonary embolism within 90 days of administering one of the drugs studied</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>90 day risk of deep venous thrombosis</measure>
      <time_frame>90 days</time_frame>
      <description>Risk of pulmonary embolism within 90 days of administering one of the drugs studied</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Heparin induced thrombocytopenia</measure>
      <time_frame>90 days</time_frame>
      <description>Risk of heparin induced thrombocytopenia defined by; thrombocytes less than 150 x 109/l and presence of HIT antibodies</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Liver failure</measure>
      <time_frame>90 days</time_frame>
      <description>Risk of liver failure defined by ALAT 3X upper limit of normal</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital admission</measure>
      <time_frame>Admission time (up to 1 year from inclusion measured in days)</time_frame>
      <description>Length of hospital admission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days alive out of hospital</measure>
      <time_frame>Time out of hospital (up to 1 year from inclusion measured in days)</time_frame>
      <description>Days alive out of hospital</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Pregnancy loss</measure>
      <time_frame>9 months</time_frame>
      <description>Risk of pregnancy loss during treatment with either of the two drugs studied</description>
    </other_outcome>
    <other_outcome>
      <measure>Stillbirth</measure>
      <time_frame>9 months</time_frame>
      <description>Risk of stillbirth during treatment with either of the two drugs studied</description>
    </other_outcome>
    <other_outcome>
      <measure>Antepartum bleeding</measure>
      <time_frame>9 months</time_frame>
      <description>Risk of antepartum bleeding during treatment with either of the two drugs studied</description>
    </other_outcome>
    <other_outcome>
      <measure>Postpartum bleeding</measure>
      <time_frame>up to 365 days</time_frame>
      <description>Risk of postpartum bleeding during treatment with either of the two drugs studied</description>
    </other_outcome>
    <other_outcome>
      <measure>Placental complications</measure>
      <time_frame>9 months</time_frame>
      <description>Risk of placental complications (Abruptio placenta, placenta prevue) during treatment with either of the two drugs studied</description>
    </other_outcome>
    <other_outcome>
      <measure>Preeclampsia</measure>
      <time_frame>9 months</time_frame>
      <description>Risk of preeclampsia and eclampsia during treatment with either of the two drugs studied</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">65000</enrollment>
    <condition>Anticoagulant</condition>
    <condition>Venous Thromboembolism</condition>
    <condition>Prophylaxis</condition>
    <condition>Treatment</condition>
    <arm_group>
      <arm_group_label>Dalteparin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Tinzaparin</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dalteparin Prefilled Syringe</intervention_name>
      <description>Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.</description>
      <arm_group_label>Tinzaparin</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tinzaparin profiled syringe</intervention_name>
      <description>Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.</description>
      <arm_group_label>Dalteparin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients with indication for low molecular weight heparin&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients under the age of 18&#xD;
  &#xD;
            -  Patients who are incapable of understanding the written material received&#xD;
  &#xD;
            -  Patients who after being informed in writing chooses not to participate&#xD;
  &#xD;
            -  Patients with contraindications for low molecular weight heparins as described in the&#xD;
               SmPC&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Kasper Iversen, Professor, MD</last_name>
      <phone>+ 45 28712753</phone>
      <email>Kasper.Karmark.Iversen@regionh.dk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lars Køber, Professor, MD</last_name>
      <phone>+ 45 35458525</phone>
      <email>lars.koeber01@regionh.dk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Amager-Hvidovre Hospital</name>
        <address>
          <city>Copenhagen</city>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Henriette Svarre, Professor, MD</last_name>
        <email>Henriette.Svarre.Nielsen@regionh.dk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Frederiksberg and Bispebjerg Hospital</name>
        <address>
          <city>Copenhagen</city>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Søren Overgaard, Professor, MD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Rigshospitalet</name>
        <address>
          <city>Copenhagen</city>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lars Køber, Professor, MD</last_name>
        <email>Lars.Koeber.01@regionh.dk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Herlev and Gentofte Hospital</name>
        <address>
          <city>Herlev</city>
          <zip>2730</zip>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kasper K Iversen, MD, DMsc</last_name>
        <email>Kasper.Karmark.Iversen@regionh.dk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nordsjællands Hospital</name>
        <address>
          <city>Hillerød</city>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Morten Bestle, Professor, MD</last_name>
        <email>Morten.Bestle@regionh.dk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nykøbing Falster Hospital</name>
        <address>
          <city>Nykøbing Falster</city>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jacob Fyhring Mortensen, MD</last_name>
      </contact>
      <contact_backup>
        <last_name>Jmot@regionsjaelland.dk</last_name>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Næstved, Ringsted, Slagelse Hospital</name>
        <address>
          <city>Næstved</city>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Henrik Stig Jørgensen, MD</last_name>
        <email>henjor@regionsjaelland.dk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Roskilde, Køge Hospital</name>
        <address>
          <city>Roskilde</city>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lasse Bremholm</last_name>
        <email>labha@regionsjaelland.dk</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Bornholm Hospital</name>
        <address>
          <city>Rønne</city>
          <country>Denmark</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Diana Kaiser</last_name>
        <email>diana.utech.kaiser@regionh.dk</email>
      </contact>
    </location>
    <location_countries>
      <country>Denmark</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>March 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Herlev Hospital</investigator_affiliation>
      <investigator_full_name>Kasper Iversen</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thromboembolism</mesh_term>
      <mesh_term>Venous Thromboembolism</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dalteparin</mesh_term>
      <mesh_term>Tinzaparin</mesh_term>
      <mesh_term>Heparin, Low-Molecular-Weight</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020560
  org study id: DANHEP
  nct id: NCT06020560
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  DANHEP is a cluster randomized study of two different low molecular weight heparins.
        Parenteral anticoagulants are used in a variety of settings, including treatment and
        prevention of venous thromboembolism in cancer patients, medical patients, and surgical
        patients, along with the use as adjuvant therapy for coronary syndromes. The most frequently
        used parenteral anticoagulants in Denmark, include the two different low molecular weight
        heparins; dalteparin and tinzaparin. The two drugs are considered equally efficient and safe
        regarding treatment and prevention of thrombosis and risk of bleeding. Importantly, there is
        a lack of evidence regarding whether these drugs are in fact comparable. The aim of this
        study is therefore to investigate the comparative safety and efficacy of the two different
        low molecular weight heparins (dalteparin and tinzaparin using cluster randomization in
        patients with an indication for low molecular weight heparins.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: 30-day all-cause mortality and bleeding requiring blood transfusion
  time frame: 30 days
  description: To evaluate whether treatment with any of the low molecular weight heparins will increase the risk of bleeding requiring blood transfusion during admission or death within 30 days in patients with indication for low molecular weight heparins.
  measure: 30-day all-cause mortality
  time frame: 30 days
  description: Risk of all-cause mortality within 30 days of administering one of the studied drugs
  measure: 365-day all-cause mortality
  time frame: 365 days
  description: Risk of all-cause mortality within 365 days of administering one of the studied drugs
  measure: Blood transfusion during admission
  time frame: 90 days
  description: Blood transfusion defined from use of blood products
  measure: 90 day risk of pulmonary embolism
  time frame: 90 days
  description: Risk of pulmonary embolism within 90 days of administering one of the drugs studied
  measure: 90 day risk of deep venous thrombosis
  time frame: 90 days
  description: Risk of pulmonary embolism within 90 days of administering one of the drugs studied
  measure: Heparin induced thrombocytopenia
  time frame: 90 days
  description: Risk of heparin induced thrombocytopenia defined by; thrombocytes less than 150 x 109/l and presence of HIT antibodies
  measure: Liver failure
  time frame: 90 days
  description: Risk of liver failure defined by ALAT 3X upper limit of normal
  measure: Length of hospital admission
  time frame: Admission time (up to 1 year from inclusion measured in days)
  description: Length of hospital admission
  measure: Days alive out of hospital
  time frame: Time out of hospital (up to 1 year from inclusion measured in days)
  description: Days alive out of hospital
  measure: Pregnancy loss
  time frame: 9 months
  description: Risk of pregnancy loss during treatment with either of the two drugs studied
  measure: Stillbirth
  time frame: 9 months
  description: Risk of stillbirth during treatment with either of the two drugs studied
  measure: Antepartum bleeding
  time frame: 9 months
  description: Risk of antepartum bleeding during treatment with either of the two drugs studied
  measure: Postpartum bleeding
  time frame: up to 365 days
  description: Risk of postpartum bleeding during treatment with either of the two drugs studied
  measure: Placental complications
  time frame: 9 months
  description: Risk of placental complications (Abruptio placenta, placenta prevue) during treatment with either of the two drugs studied
  measure: Preeclampsia
  time frame: 9 months
  description: Risk of preeclampsia and eclampsia during treatment with either of the two drugs studied
  arm group label: Dalteparin
  arm group type: Active Comparator
  arm group label: Tinzaparin
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: Dalteparin Prefilled Syringe
  description: Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.
  arm group label: Tinzaparin
  intervention type: Drug
  intervention name: Tinzaparin profiled syringe
  description: Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.
  arm group label: Dalteparin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Kasper Iversen, Professor, MD
  phone: + 45 28712753
  email: Kasper.Karmark.Iversen@regionh.dk
  last name: Lars Køber, Professor, MD
  phone: + 45 35458525
  email: lars.koeber01@regionh.dk
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  country: Denmark
  responsible party type: Principal Investigator
  investigator affiliation: Herlev Hospital
  investigator full name: Kasper Iversen
  investigator title: Clinical Professor
  mesh term: Thromboembolism
  mesh term: Venous Thromboembolism
  mesh term: Dalteparin
  mesh term: Tinzaparin
  mesh term: Heparin, Low-Molecular-Weight
  sharing ipd: No