<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/NCT02987946</url>
  </required_header>
  <id_info>
    <org_study_id>NL56552.058.16</org_study_id>
    <nct_id>NCT02987946</nct_id>
  </id_info>
  <brief_title>Leiden Trial In Prevention of Post-Operative ThromboEmbolic Events</brief_title>
  <acronym>TIPOTEE</acronym>
  <official_title>Optimizing Anti Coagulant Therapy in Neurosurgical Interventions in Patients With an Increased Risk for Thrombo-embolic Complications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Leiden University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medtronic - MITG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Leiden University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In neurosurgical patients, the risk for venous thromboembolic events (VTE) is high due to the&#xD;
      relatively long duration of surgery, the high occurrence of prolonged immobilization of&#xD;
      patients due to paresis of the legs or intracranial pathology causing inability to mobilise2.&#xD;
      Moreover, intracranial and intraspinal tumours and subarachnoid haemorrhage cause&#xD;
      hypercoagulability, which increases the risk on VTE. There is a high degree of diversity in&#xD;
      attributed risk on thrombosis in the neurosurgical patient cohort. Due to this diversity,&#xD;
      insufficient power of performed studies and lack of careful phenotyping and description of&#xD;
      risk factors in previous studies on deep venous thrombosis (DVT) prophylaxis, as yet the&#xD;
      optimal DVT prophylaxis in neurosurgery remains unclear. A prospective randomized study with&#xD;
      adequate power and detailed information on patient related factors (malignancy, subarachnoid&#xD;
      haemorrhage, prevailing coagulopathies), type of surgery, duration of surgery, and&#xD;
      postoperative immobilisation will allow us to identify the optimal treatment strategy for&#xD;
      high risk neurosurgical patients.&#xD;
&#xD;
      In the current study all patients that fulfil the inclusion criteria will be subjected to&#xD;
      post-operative systematic evaluation of VTE by echo-duplex investigation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is clear that thrombo-embolic prophylaxis is mandatory in neurosurgical interventions. The&#xD;
      current prophylactic strategy using preoperatively started low molecular-weight heparine&#xD;
      (LMWH) allows still a considerable number of thrombo-embolic complications, in particular in&#xD;
      those patients that are subjected to prolonged neurosurgical interventions. Guidelines advise&#xD;
      mechanical prophylaxis. However, these guidelines are based on literature with low grade of&#xD;
      evidence. To achieve the highest grade of evidence we will randomize subsequent patients&#xD;
      between intermittent compression stockings with preoperative LMWH prophylaxis, and LMWH as&#xD;
      stand alone prophylaxis. The last, being the current state of practice in all neurosurgical&#xD;
      patients in our ward, including the high thrombosis risk group. All patients will receive&#xD;
      preoperatively started LMWH.&#xD;
&#xD;
      There is a high degree of diversity in attributed risk on thrombosis in the neurosurgical&#xD;
      patient cohort. Due to this diversity, insufficient power of performed studies and lack of&#xD;
      careful phenotyping and description of risk factors in previous studies on deep venous&#xD;
      thrombosis (DVT) prophylaxis, as yet the optimal DVT prophylaxis in neurosurgery remains&#xD;
      unclear. A prospective randomized study with adequate power and detailed information on&#xD;
      patient related factors (malignancy, subarachnoid haemorrhage, prevailing coagulopathies),&#xD;
      type of surgery, duration of surgery, and postoperative immobilisation will allow us to&#xD;
      identify the optimal treatment strategy for high risk neurosurgical patients.&#xD;
&#xD;
      In the current study all patients that fulfil the inclusion criteria will be subjected to&#xD;
      post-operative systematic evaluation of venous thromboembolic events (VTE) by echo-duplex&#xD;
      investigation.&#xD;
&#xD;
      • 2. Goal of the study The primary goal of the current study is to investigate whether the&#xD;
      combination of perioperative intermittent pneumatic compression and LMWH has a lower&#xD;
      incidence of postoperative thrombo-embolic complications within a week after a high risk&#xD;
      neurosurgical intervention in comparison to patients receiving merely LMWH prophylaxis.&#xD;
&#xD;
      Secondary research questions are:&#xD;
&#xD;
        -  Is there a difference in number of patients with clinical symptoms of thromboembolus in&#xD;
           patients receiving the combination of peroperative intermittent pneumatic compression of&#xD;
           the lower limbs and LMWH in comparison to patients receiving merely LMWH prophylaxis in&#xD;
           high risk neurosurgical patients, scored two months after surgery;&#xD;
&#xD;
        -  What is the prevalence of VTE in high risk neurosurgical patients in the Leiden&#xD;
           University Medical Centre (LUMC) receiving LMWH prophylaxis;&#xD;
&#xD;
        -  What are the risk factors for the prevalence of VTE in high risk neurosurgical patients&#xD;
           in the LUMC;&#xD;
&#xD;
        -  What is the incidence of bleeding complications in high risk neurosurgical patients in&#xD;
           the LUMC receiving LMWH prophylaxis;&#xD;
&#xD;
        -  Is there a difference in length of hospital stay in patients receiving the combination&#xD;
           of peroperative intermittent pneumatic compression of the lower limbs and LMWH in&#xD;
           comparison to patients receiving merely LMWH prophylaxis in high risk neurosurgical&#xD;
           patients;&#xD;
&#xD;
        -  Is there a difference in patient perceived recovery at discharge and at 2 month follow&#xD;
           up in patients receiving the combination of perioperative intermittent pneumatic&#xD;
           compression and LMWH in comparison to patients receiving merely LMWH prophylaxis in high&#xD;
           risk neurosurgical patients;&#xD;
&#xD;
        -  Is there a difference in Quality of life at discharge and at 2 month follow up in&#xD;
           patients receiving the combination of perioperative intermittent pneumatic compression&#xD;
           of the legs and LMWH in comparison to patients receiving merely LMWH prophylaxis in&#xD;
           high-risk neurosurgical patients;&#xD;
&#xD;
        -  Is it relevant to consider cost-effectiveness of the use of perioperative intermittent&#xD;
           pneumatic compression of the legs and if so, what is the cost-effectiveness?&#xD;
&#xD;
        -  3. Randomized controlled trial This is a randomized controlled trial on high-risk&#xD;
           neurosurgical patients in a University hospital (see inclusion and exclusion criteria)&#xD;
           in which consecutive patients who meet the inclusion criteria are invited to participate&#xD;
           in the trial. Clinical and demographic data are gathered, as well as surgical details&#xD;
           and prevailing complications. Postoperative bleeding requiring secondary surgery or&#xD;
           lengthening of hospital stay will be documented as a clinically relevant bleeding&#xD;
           complication. All patients receive Fraxiparine 2850 IU (international units) daily,&#xD;
           starting preoperatively compatible with current practice. At admission patients will be&#xD;
           randomized to be subjected to perioperative (48 hrs) intermittent pneumatic compression&#xD;
           or standard care. Following current guidelines in the LUMC the Fraxiparine dose is&#xD;
           doubled to 5600 IU in patients with a weight above 100 kg.&#xD;
&#xD;
      All randomized patients will receive a postoperative doppler examination of the major veins&#xD;
      of both lower limb in order to identify a possible VTE. A post-operative thrombo-embolic&#xD;
      complication is defined as follows7:&#xD;
&#xD;
        1. Asymptomatic VTE confirmed by echo Doppler;&#xD;
&#xD;
        2. Symptomatic VTE confirmed by echo Doppler;&#xD;
&#xD;
        3. Symptomatic pulmonary embolism (PE) confirmed by CT scan&#xD;
&#xD;
        4. Fatal pulmonary embolism confirmed by autopsy&#xD;
&#xD;
      &gt; 3.1 Population The neurosurgical patient has an increased risk on thrombo-embolic&#xD;
      complications because he is subjected to an intervention that in general takes a long time&#xD;
      and causes the patient to be immobilized during a longer period (during and directly after&#xD;
      surgery). Moreover, the pathology is frequently carcinomatous, having an increased risk for&#xD;
      thrombo-embolic events by nature. The in- and exclusion criteria are aiming at these&#xD;
      properties of the patients. All consecutive patients that fulfil the criteria will be invited&#xD;
      to participate in this study. In order to be included the patient has to sign an informed&#xD;
      consent. Based on a power analysis 140 patients in both randomization arms have to be&#xD;
      included (based on a VTE incidence of 15% which will decrease to 5% after treatment with&#xD;
      intermittent pneumatic leg pumps during surgery; alpha 0.05, power 80%) to be able to obtain&#xD;
      a significant effect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">March 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lower incidence of thromboembolic complications in patients with IPD + LMWH by adding IPD to usual care, established with systematic doppler/duplex evaluation in all patients at 5 +/- 2 days post surgery</measure>
    <time_frame>1 week</time_frame>
    <description>The primary goal of the current study is to investigate whether the combination of perioperative intermittent pneumatic compression and LMWH has a lower incidence of postoperative thrombo-embolic complications within a week after a high risk neurosurgical intervention in comparison to patients receiving merely LMWH prophylaxis. All patients will be subjected to doppler/duplex in the week after surgery. Follow up of all patients will be performed at 5 +/- 2 days after surgery, during admission time. At this time all patient will have a duplex ultrasound examination to assess the prevalence of a possible deep venous thrombosis. This period has been chosen in analogy with existing literature (appendix A). 9-15 For this examination patients have to be able stand upright. Therefore in some cases (e.g ICU patients) the interval will be longer, with a maximum of 20 days.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>prevalence of DVT measured by duplex/doppler routinely performed in the whole study population</measure>
    <time_frame>1 week</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical signs of DVT i.e. swollen,painful and red leg or pulmonary embolism</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life by EQ-5D</measure>
    <time_frame>2 mos after surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient perceived recovery with Likert scale</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness with EQ-5D and estimated costs in cost diaries</measure>
    <time_frame>2 months</time_frame>
    <description>is the additional use of IPD cost effective in prevention of DVT in neurosurgical patients</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Deep-Venous Thrombosis</condition>
  <arm_group>
    <arm_group_label>Fraxiparine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention: All patients receive Fraxiparine 2850 IE daily, starting preoperatively compatible with current practice. After randomization the patients in this arm will be subjected to fraxipareine 2850 IE daily. According to current guidelines in the LUMC the Fraxiparine dose is doubled to 5600 IE in patients with a weight above 100 kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IPD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: IPD Device: After randomization the patients in this arm will be subjected to fraxiparine 2850 IE daily and intermittent pressure devices for at least 48 hours or until mobilization. The intermittent pressure device is a leg pump delivered by Converis(R).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>IPD Device delivered by Converis</intervention_name>
    <description>After randomization patients will be subjected to perioperative (48 hrs) intermittent pneumatic compression.</description>
    <arm_group_label>IPD</arm_group_label>
    <other_name>IPD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fraxiparine</intervention_name>
    <description>All patients receive Fraxiparine 2850 IE daily, starting preoperatively compatible with current practice.</description>
    <arm_group_label>Fraxiparine</arm_group_label>
    <arm_group_label>IPD</arm_group_label>
    <other_name>LMWH</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:• Intracranial surgery;&#xD;
&#xD;
          -  Tumour surgery (spinal or intracranial);&#xD;
&#xD;
          -  &gt;180 min estimated surgical intervention time;&#xD;
&#xD;
          -  &gt;240 min time under anaesthesia;&#xD;
&#xD;
          -  Spine trauma surgery;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Age under 18 years;&#xD;
&#xD;
               -  Perioperative continuation of anti coagulant therapy indicated other than&#xD;
                  prophylactic LMWH;&#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_official>
    <last_name>Carmen Vleggeert-Lankamp, MD MSc PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Leiden University Medical Centre</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Carmen Vleggeert-Lankamp, MD MSc PhD</last_name>
    <phone>+31715262093</phone>
    <email>cvleggeert@lumc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Menno Huisman, Prof dr</last_name>
    <phone>+31715269111</phone>
    <email>m.v.huisman@lumc.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Leiden University Medical Centre</name>
      <address>
        <city>Leiden</city>
        <state>Zuid Holland</state>
        <zip>2300RC</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>carmen vleggeert-lankamp, MD MSc PhD</last_name>
      <phone>+31630925428</phone>
      <email>cvleggeert@lumc.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
    <investigator_full_name>C.L.A.Vleggeert-Lankamp</investigator_full_name>
    <investigator_title>MD MSc PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Venous Thrombosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nadroparin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02987946
org study id: NL56552.058.16
nct id: NCT02987946
lead sponsor: 
collaborator: 
has dmc: No
In neurosurgical patients, the risk for venous thromboembolic events (VTE) is high due to the
      relatively long duration of surgery, the high occurrence of prolonged immobilization of
      patients due to paresis of the legs or intracranial pathology causing inability to mobilise2.
      Moreover, intracranial and intraspinal tumours and subarachnoid haemorrhage cause
      hypercoagulability, which increases the risk on VTE. There is a high degree of diversity in
      attributed risk on thrombosis in the neurosurgical patient cohort. Due to this diversity,
      insufficient power of performed studies and lack of careful phenotyping and description of
      risk factors in previous studies on deep venous thrombosis (DVT) prophylaxis, as yet the
      optimal DVT prophylaxis in neurosurgery remains unclear. A prospective randomized study with
      adequate power and detailed information on patient related factors (malignancy, subarachnoid
      haemorrhage, prevailing coagulopathies), type of surgery, duration of surgery, and
      postoperative immobilisation will allow us to identify the optimal treatment strategy for
      high risk neurosurgical patients.

      In the current study all patients that fulfil the inclusion criteria will be subjected to
      post-operative systematic evaluation of VTE by echo-duplex investigation.
It is clear that thrombo-embolic prophylaxis is mandatory in neurosurgical interventions. The
      current prophylactic strategy using preoperatively started low molecular-weight heparine
      (LMWH) allows still a considerable number of thrombo-embolic complications, in particular in
      those patients that are subjected to prolonged neurosurgical interventions. Guidelines advise
      mechanical prophylaxis. However, these guidelines are based on literature with low grade of
      evidence. To achieve the highest grade of evidence we will randomize subsequent patients
      between intermittent compression stockings with preoperative LMWH prophylaxis, and LMWH as
      stand alone prophylaxis. The last, being the current state of practice in all neurosurgical
      patients in our ward, including the high thrombosis risk group. All patients will receive
      preoperatively started LMWH.

      There is a high degree of diversity in attributed risk on thrombosis in the neurosurgical
      patient cohort. Due to this diversity, insufficient power of performed studies and lack of
      careful phenotyping and description of risk factors in previous studies on deep venous
      thrombosis (DVT) prophylaxis, as yet the optimal DVT prophylaxis in neurosurgery remains
      unclear. A prospective randomized study with adequate power and detailed information on
      patient related factors (malignancy, subarachnoid haemorrhage, prevailing coagulopathies),
      type of surgery, duration of surgery, and postoperative immobilisation will allow us to
      identify the optimal treatment strategy for high risk neurosurgical patients.

      In the current study all patients that fulfil the inclusion criteria will be subjected to
      post-operative systematic evaluation of venous thromboembolic events (VTE) by echo-duplex
      investigation.

      • 2. Goal of the study The primary goal of the current study is to investigate whether the
      combination of perioperative intermittent pneumatic compression and LMWH has a lower
      incidence of postoperative thrombo-embolic complications within a week after a high risk
      neurosurgical intervention in comparison to patients receiving merely LMWH prophylaxis.

      Secondary research questions are:

        -  Is there a difference in number of patients with clinical symptoms of thromboembolus in
           patients receiving the combination of peroperative intermittent pneumatic compression of
           the lower limbs and LMWH in comparison to patients receiving merely LMWH prophylaxis in
           high risk neurosurgical patients, scored two months after surgery;

        -  What is the prevalence of VTE in high risk neurosurgical patients in the Leiden
           University Medical Centre (LUMC) receiving LMWH prophylaxis;

        -  What are the risk factors for the prevalence of VTE in high risk neurosurgical patients
           in the LUMC;

        -  What is the incidence of bleeding complications in high risk neurosurgical patients in
           the LUMC receiving LMWH prophylaxis;

        -  Is there a difference in length of hospital stay in patients receiving the combination
           of peroperative intermittent pneumatic compression of the lower limbs and LMWH in
           comparison to patients receiving merely LMWH prophylaxis in high risk neurosurgical
           patients;

        -  Is there a difference in patient perceived recovery at discharge and at 2 month follow
           up in patients receiving the combination of perioperative intermittent pneumatic
           compression and LMWH in comparison to patients receiving merely LMWH prophylaxis in high
           risk neurosurgical patients;

        -  Is there a difference in Quality of life at discharge and at 2 month follow up in
           patients receiving the combination of perioperative intermittent pneumatic compression
           of the legs and LMWH in comparison to patients receiving merely LMWH prophylaxis in
           high-risk neurosurgical patients;

        -  Is it relevant to consider cost-effectiveness of the use of perioperative intermittent
           pneumatic compression of the legs and if so, what is the cost-effectiveness?

        -  3. Randomized controlled trial This is a randomized controlled trial on high-risk
           neurosurgical patients in a University hospital (see inclusion and exclusion criteria)
           in which consecutive patients who meet the inclusion criteria are invited to participate
           in the trial. Clinical and demographic data are gathered, as well as surgical details
           and prevailing complications. Postoperative bleeding requiring secondary surgery or
           lengthening of hospital stay will be documented as a clinically relevant bleeding
           complication. All patients receive Fraxiparine 2850 IU (international units) daily,
           starting preoperatively compatible with current practice. At admission patients will be
           randomized to be subjected to perioperative (48 hrs) intermittent pneumatic compression
           or standard care. Following current guidelines in the LUMC the Fraxiparine dose is
           doubled to 5600 IU in patients with a weight above 100 kg.

      All randomized patients will receive a postoperative doppler examination of the major veins
      of both lower limb in order to identify a possible VTE. A post-operative thrombo-embolic
      complication is defined as follows7:

        1. Asymptomatic VTE confirmed by echo Doppler;

        2. Symptomatic VTE confirmed by echo Doppler;

        3. Symptomatic pulmonary embolism (PE) confirmed by CT scan

        4. Fatal pulmonary embolism confirmed by autopsy

      > 3.1 Population The neurosurgical patient has an increased risk on thrombo-embolic
      complications because he is subjected to an intervention that in general takes a long time
      and causes the patient to be immobilized during a longer period (during and directly after
      surgery). Moreover, the pathology is frequently carcinomatous, having an increased risk for
      thrombo-embolic events by nature. The in- and exclusion criteria are aiming at these
      properties of the patients. All consecutive patients that fulfil the criteria will be invited
      to participate in this study. In order to be included the patient has to sign an informed
      consent. Based on a power analysis 140 patients in both randomization arms have to be
      included (based on a VTE incidence of 15% which will decrease to 5% after treatment with
      intermittent pneumatic leg pumps during surgery; alpha 0.05, power 80%) to be able to obtain
      a significant effect.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Lower incidence of thromboembolic complications in patients with IPD + LMWH by adding IPD to usual care, established with systematic doppler/duplex evaluation in all patients at 5 +/- 2 days post surgery
time frame: 1 week
description: The primary goal of the current study is to investigate whether the combination of perioperative intermittent pneumatic compression and LMWH has a lower incidence of postoperative thrombo-embolic complications within a week after a high risk neurosurgical intervention in comparison to patients receiving merely LMWH prophylaxis. All patients will be subjected to doppler/duplex in the week after surgery. Follow up of all patients will be performed at 5 +/- 2 days after surgery, during admission time. At this time all patient will have a duplex ultrasound examination to assess the prevalence of a possible deep venous thrombosis. This period has been chosen in analogy with existing literature (appendix A). 9-15 For this examination patients have to be able stand upright. Therefore in some cases (e.g ICU patients) the interval will be longer, with a maximum of 20 days.
measure: prevalence of DVT measured by duplex/doppler routinely performed in the whole study population
time frame: 1 week
measure: Clinical signs of DVT i.e. swollen,painful and red leg or pulmonary embolism
time frame: 2 months
measure: Quality of life by EQ-5D
time frame: 2 mos after surgery
measure: Patient perceived recovery with Likert scale
time frame: 2 months
measure: Cost effectiveness with EQ-5D and estimated costs in cost diaries
time frame: 2 months
description: is the additional use of IPD cost effective in prevention of DVT in neurosurgical patients
arm group label: Fraxiparine
arm group type: Active Comparator
description: Intervention: All patients receive Fraxiparine 2850 IE daily, starting preoperatively compatible with current practice. After randomization the patients in this arm will be subjected to fraxipareine 2850 IE daily. According to current guidelines in the LUMC the Fraxiparine dose is doubled to 5600 IE in patients with a weight above 100 kg.
arm group label: IPD
arm group type: Experimental
description: Intervention: IPD Device: After randomization the patients in this arm will be subjected to fraxiparine 2850 IE daily and intermittent pressure devices for at least 48 hours or until mobilization. The intermittent pressure device is a leg pump delivered by Converis(R).
intervention type: Device
intervention name: IPD Device delivered by Converis
description: After randomization patients will be subjected to perioperative (48 hrs) intermittent pneumatic compression.
arm group label: IPD
other name: IPD
intervention type: Drug
intervention name: Fraxiparine
description: All patients receive Fraxiparine 2850 IE daily, starting preoperatively compatible with current practice.
arm group label: Fraxiparine
arm group label: IPD
other name: LMWH
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Carmen Vleggeert-Lankamp, MD MSc PhD
role: Principal Investigator
affiliation: Leiden University Medical Centre
last name: Carmen Vleggeert-Lankamp, MD MSc PhD
phone: +31715262093
email: cvleggeert@lumc.nl
last name: Menno Huisman, Prof dr
phone: +31715269111
email: m.v.huisman@lumc.nl
facility: 
status: Recruiting
contact: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Leiden University Medical Center
investigator full name: C.L.A.Vleggeert-Lankamp
investigator title: MD MSc PhD
mesh term: Thrombosis
mesh term: Venous Thrombosis
mesh term: Nadroparin
sharing ipd: Undecided