<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/NCT03255928</url>
  </required_header>
  <id_info>
    <org_study_id>PASVAD v. n°1 10/03/2017</org_study_id>
    <nct_id>NCT03255928</nct_id>
  </id_info>
  <brief_title>Dynamics of Platelet Activation in Patients With Ventricular Assist Device (VAD)</brief_title>
  <acronym>PASVAD</acronym>
  <official_title>Analysis of the Platelet Activity State in Patients Implanted With Ventricular Assist Device (VAD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Scientific Institute San Raffaele</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Università Vita-Salute San Raffaele</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Scientific Institute San Raffaele</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Consenting patients with end-stage heart failure that are implanted with/candidates for&#xD;
      implant of a short-term/durable mechanical circulatory support device (e.g.: percutaneous&#xD;
      microaxial pumps (Impella), extracorporeal membrane oxygenator (ECMO), Ventricular Assist&#xD;
      Device (VAD) will be enrolled in the study.&#xD;
&#xD;
      Aim of the study is to evaluate the patients' haemostatic and coagulation profile, how it&#xD;
      interacts with the support device as well as the effect of antithrombotic drugs. From these&#xD;
      data, it will be possible to derive the mechanisms triggering post-implant&#xD;
      thromboembolic/hemorrhagic complications and to identify potential therapeutic targets.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is aimed at evaluating the patients' haemostatic and coagulation profile focusing,&#xD;
      in particular, on platelet function. Platelet function will be analyzed utilizing two&#xD;
      innovative analytic diagnostic tests, namely i) the Platelet Activity State (PAS) assay and&#xD;
      ii) the Thrombin Generation Test (TGT).&#xD;
&#xD;
      PAS values and TGT will be measured at different time-points over the course of support:&#xD;
&#xD;
      i) before the implant of the support system, to define baseline patients' characteristics;&#xD;
      ii) in the early-post implant, during patient hospitalization; iii) during long-term follow&#xD;
      up, to evaluate the dynamics of platelet function over the course of support and potential&#xD;
      alterations of platelet-mediated haemostatic processes; iv) at the occurrence of any&#xD;
      thromboembolic/hemorrhagic complication or following a modification of the antithrombotic&#xD;
      pharmacological therapy.&#xD;
&#xD;
      Platelet function will be evaluated through:&#xD;
&#xD;
      i) the Platelet Activity State (PAS) assay, a biochemical assay able to quantify the platelet&#xD;
      thrombin production rate and to correlate this rate with the actual level of platelet&#xD;
      activation (i.e., the platelet pro-thrombotic tendency); ii) the Thrombin Generation Test&#xD;
      (TGT), a biochemical assay that the investigators have properly modified to account&#xD;
      selectively for the platelet contribution on plasmatic thrombin generation.&#xD;
&#xD;
      PAS and TGT experimental values will be correlated with the occurrences of post-implant&#xD;
      complications. Experimental values will be also correlated with standard clinical parameters&#xD;
      of coagulation and hemolysis, such as: platelet count, hematocrit, hemoglobin, prothrombin&#xD;
      time (PT), activated partial thromboplastin time (aPTT), International Normalized Ratio&#xD;
      (INR), D-Dimer, Fibrinogen, L-lactate dehydrogenase, haptoglobin, plasma-free hemoglobin, and&#xD;
      C-reactive protein levels. Also levels of thrombin-antithrombin complex, Von Willebrand&#xD;
      factor, prothrombin1,2 fraction and tissue factor, will be measured and recorded. In&#xD;
      addition, pump (i.e. VAD) working parameters (i.e., rotation velocity, cardiac outflow and&#xD;
      power consumption) will be recorded. Log-files of the pump will be downloaded and analyzed to&#xD;
      characterize the correlation with the development of adverse events (AV). Finally,&#xD;
      antithrombotic therapy will be recorded and used in the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 29, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2022</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>2 Years</target_duration>
  <primary_outcome>
    <measure>Number of participants with treatment-related adverse events. Change of PAS assay from baseline to 24 months post-implant</measure>
    <time_frame>Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE</time_frame>
    <description>Correlation between platelet activation and the development of post-implant complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with treatment-related adverse events. Change of TGT from baseline to 24-months post-implant</measure>
    <time_frame>Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE</time_frame>
    <description>Correlation between platelet pro-thrombinase activity and the development of post-implant complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with treatment-related adverse events. Change of clinical and coagulation parameters from baseline to 24-months post-implant</measure>
    <time_frame>Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE</time_frame>
    <description>Correlation between coagulation parameters and the development of post-implant complications</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of participants with treatment-related adverse events. Change of pump working conditions after the device implant</measure>
    <time_frame>Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE</time_frame>
    <description>Correlation between pump working conditions and the development of post-implant complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events. Change of prescribed antithrombotic therapy (anticoagulation and antiplatelet drugs) from baseline to 24 months post-implant</measure>
    <time_frame>Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE</time_frame>
    <description>Correlation between antithrombotic therapy and the development of post-implant complications</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Thrombosis</condition>
  <condition>Blood Coagulation Disorder</condition>
  <condition>Platelet Thrombus</condition>
  <condition>Platelet Dysfunction Due to Aspirin</condition>
  <condition>Failure;Ventricular</condition>
  <arm_group>
    <arm_group_label>VAD-implanted patients</arm_group_label>
    <description>All patients receiving a VAD implant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VAD-patients suffering adverse events (AE)</arm_group_label>
    <description>VAD-patients sustaining a thromboembolic/bleeding complication over the course of support</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>PAS assay, TGT</intervention_name>
    <description>Evaluation of platelet function</description>
    <arm_group_label>VAD-implanted patients</arm_group_label>
    <arm_group_label>VAD-patients suffering adverse events (AE)</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Platelet-free-plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with end-stage heart failure receiving a mechanical circulatory support system&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All consenting patients candidates for short-term (Impella, ECMO) or durable (LVAD)&#xD;
             mechanical circulatory support device implantation&#xD;
&#xD;
          -  All consenting patients that are implanted with short-term (Impella, ECMO) or durable&#xD;
             (LVAD) mechanical circulatory support device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Patients &lt; 18-years old&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Federico Pappalardo, MD</last_name>
    <phone>00390226434524</phone>
    <email>pappalardo.federico@hsr.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>San Raffaele Scientifc Institute - Cardiothoracic Intensive Care Unit</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marina Pieri, MD</last_name>
      <email>pieri.marina@hsr.it</email>
    </contact>
    <contact_backup>
      <last_name>Filippo Consolo, PhD</last_name>
      <phone>00390226436153</phone>
      <email>consolo.filippo@unisr.it</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Valerio L, Consolo F, Bluestein D, Tran P, Slepian M, Redaelli A, Pappalardo F. Shear-mediated platelet activation in patients implanted with continuous flow LVADs: A preliminary study utilizing the platelet activity state (PAS) assay. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:1255-8. doi: 10.1109/EMBC.2015.7318595.</citation>
    <PMID>26736495</PMID>
  </reference>
  <reference>
    <citation>Consolo F, Sheriff J, Gorla S, Magri N, Bluestein D, Pappalardo F, Slepian MJ, Fiore GB, Redaelli A. High Frequency Components of Hemodynamic Shear Stress Profiles are a Major Determinant of Shear-Mediated Platelet Activation in Therapeutic Blood Recirculating Devices. Sci Rep. 2017 Jul 10;7(1):4994. doi: 10.1038/s41598-017-05130-5.</citation>
    <PMID>28694489</PMID>
  </reference>
  <reference>
    <citation>Sheriff J, Girdhar G, Chiu WC, Jesty J, Slepian MJ, Bluestein D. Comparative efficacy of in vitro and in vivo metabolized aspirin in the DeBakey ventricular assist device. J Thromb Thrombolysis. 2014 May;37(4):499-506. doi: 10.1007/s11239-013-0997-6.</citation>
    <PMID>24043375</PMID>
  </reference>
  <reference>
    <citation>Sheriff J, Bluestein D, Girdhar G, Jesty J. High-shear stress sensitizes platelets to subsequent low-shear conditions. Ann Biomed Eng. 2010 Apr;38(4):1442-50. doi: 10.1007/s10439-010-9936-2. Epub 2010 Feb 5.</citation>
    <PMID>20135353</PMID>
  </reference>
  <reference>
    <citation>Jesty J, Bluestein D. Acetylated prothrombin as a substrate in the measurement of the procoagulant activity of platelets: elimination of the feedback activation of platelets by thrombin. Anal Biochem. 1999 Jul 15;272(1):64-70. doi: 10.1006/abio.1999.4148.</citation>
    <PMID>10405294</PMID>
  </reference>
  <reference>
    <citation>Slepian MJ, Sheriff J, Hutchinson M, Tran P, Bajaj N, Garcia JGN, Scott Saavedra S, Bluestein D. Shear-mediated platelet activation in the free flow: Perspectives on the emerging spectrum of cell mechanobiological mechanisms mediating cardiovascular implant thrombosis. J Biomech. 2017 Jan 4;50:20-25. doi: 10.1016/j.jbiomech.2016.11.016. Epub 2016 Nov 10.</citation>
    <PMID>27887727</PMID>
  </reference>
  <reference>
    <citation>Rogers JG, Pagani FD, Tatooles AJ, Bhat G, Slaughter MS, Birks EJ, Boyce SW, Najjar SS, Jeevanandam V, Anderson AS, Gregoric ID, Mallidi H, Leadley K, Aaronson KD, Frazier OH, Milano CA. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):451-460. doi: 10.1056/NEJMoa1602954.</citation>
    <PMID>28146651</PMID>
  </reference>
  <reference>
    <citation>Slaughter MS, Pagani FD, McGee EC, Birks EJ, Cotts WG, Gregoric I, Howard Frazier O, Icenogle T, Najjar SS, Boyce SW, Acker MA, John R, Hathaway DR, Najarian KB, Aaronson KD; HeartWare Bridge to Transplant ADVANCE Trial Investigators. HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant. 2013 Jul;32(7):675-83. doi: 10.1016/j.healun.2013.04.004.</citation>
    <PMID>23796152</PMID>
  </reference>
  <reference>
    <citation>Valerio L, Tran PL, Sheriff J, Brengle W, Ghosh R, Chiu WC, Redaelli A, Fiore GB, Pappalardo F, Bluestein D, Slepian MJ. Aspirin has limited ability to modulate shear-mediated platelet activation associated with elevated shear stress of ventricular assist devices. Thromb Res. 2016 Apr;140:110-117. doi: 10.1016/j.thromres.2016.01.026. Epub 2016 Feb 1.</citation>
    <PMID>26938158</PMID>
  </reference>
  <reference>
    <citation>Consolo F, Sferrazza G, Motolone G, Contri R, Valerio L, Lembo R, Pozzi L, Della Valle P, De Bonis M, Zangrillo A, Fiore GB, Redaelli A, Slepian MJ, Pappalardo F. Platelet activation is a preoperative risk factor for the development of thromboembolic complications in patients with continuous-flow left ventricular assist device. Eur J Heart Fail. 2018 Apr;20(4):792-800. doi: 10.1002/ejhf.1113. Epub 2017 Dec 28.</citation>
    <PMID>29282819</PMID>
  </reference>
  <reference>
    <citation>Consolo F, Pozzi L, Sferrazza G, Della Valle P, D'Angelo A, Slepian MJ, Pappalardo F. Which Antiplatelet Therapy in Patients With Left Ventricular Assist Device and Aspirin Allergy? Ann Thorac Surg. 2018 Feb;105(2):e47-e49. doi: 10.1016/j.athoracsur.2017.09.022.</citation>
    <PMID>29362190</PMID>
  </reference>
  <reference>
    <citation>Consolo F, Sferrazza G, Motolone G, Pieri M, De Bonis M, Zangrillo A, Redaelli A, Slepian MJ, Pappalardo F. Shear-Mediated Platelet Activation Enhances Thrombotic Complications in Patients With LVADs and Is Reversed After Heart Transplantation. ASAIO J. 2019 May/Jun;65(4):e33-e35. doi: 10.1097/MAT.0000000000000842.</citation>
    <PMID>29952802</PMID>
  </reference>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>May 4, 2022</last_update_submitted>
  <last_update_submitted_qc>May 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Scientific Institute San Raffaele</investigator_affiliation>
    <investigator_full_name>Filippo Consolo</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Platelet activation</keyword>
  <keyword>Ventricular Assist Device</keyword>
  <keyword>Thrombosis</keyword>
  <keyword>Bleeding</keyword>
  <keyword>Antithrombotic Pharmacological Therapy</keyword>
  <keyword>Mechanical Circulatory Support</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombosis</mesh_term>
    <mesh_term>Hemostatic Disorders</mesh_term>
    <mesh_term>Blood Coagulation Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Privacy restrictions</ipd_description>
  </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/NCT03255928
org study id: PASVAD v. n°1 10/03/2017
nct id: NCT03255928
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Consenting patients with end-stage heart failure that are implanted with/candidates for
      implant of a short-term/durable mechanical circulatory support device (e.g.: percutaneous
      microaxial pumps (Impella), extracorporeal membrane oxygenator (ECMO), Ventricular Assist
      Device (VAD) will be enrolled in the study.

      Aim of the study is to evaluate the patients' haemostatic and coagulation profile, how it
      interacts with the support device as well as the effect of antithrombotic drugs. From these
      data, it will be possible to derive the mechanisms triggering post-implant
      thromboembolic/hemorrhagic complications and to identify potential therapeutic targets.
The study is aimed at evaluating the patients' haemostatic and coagulation profile focusing,
      in particular, on platelet function. Platelet function will be analyzed utilizing two
      innovative analytic diagnostic tests, namely i) the Platelet Activity State (PAS) assay and
      ii) the Thrombin Generation Test (TGT).

      PAS values and TGT will be measured at different time-points over the course of support:

      i) before the implant of the support system, to define baseline patients' characteristics;
      ii) in the early-post implant, during patient hospitalization; iii) during long-term follow
      up, to evaluate the dynamics of platelet function over the course of support and potential
      alterations of platelet-mediated haemostatic processes; iv) at the occurrence of any
      thromboembolic/hemorrhagic complication or following a modification of the antithrombotic
      pharmacological therapy.

      Platelet function will be evaluated through:

      i) the Platelet Activity State (PAS) assay, a biochemical assay able to quantify the platelet
      thrombin production rate and to correlate this rate with the actual level of platelet
      activation (i.e., the platelet pro-thrombotic tendency); ii) the Thrombin Generation Test
      (TGT), a biochemical assay that the investigators have properly modified to account
      selectively for the platelet contribution on plasmatic thrombin generation.

      PAS and TGT experimental values will be correlated with the occurrences of post-implant
      complications. Experimental values will be also correlated with standard clinical parameters
      of coagulation and hemolysis, such as: platelet count, hematocrit, hemoglobin, prothrombin
      time (PT), activated partial thromboplastin time (aPTT), International Normalized Ratio
      (INR), D-Dimer, Fibrinogen, L-lactate dehydrogenase, haptoglobin, plasma-free hemoglobin, and
      C-reactive protein levels. Also levels of thrombin-antithrombin complex, Von Willebrand
      factor, prothrombin1,2 fraction and tissue factor, will be measured and recorded. In
      addition, pump (i.e. VAD) working parameters (i.e., rotation velocity, cardiac outflow and
      power consumption) will be recorded. Log-files of the pump will be downloaded and analyzed to
      characterize the correlation with the development of adverse events (AV). Finally,
      antithrombotic therapy will be recorded and used in the study.
observational model: Cohort
time perspective: Prospective
measure: Number of participants with treatment-related adverse events. Change of PAS assay from baseline to 24 months post-implant
time frame: Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE
description: Correlation between platelet activation and the development of post-implant complications
measure: Number of participants with treatment-related adverse events. Change of TGT from baseline to 24-months post-implant
time frame: Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE
description: Correlation between platelet pro-thrombinase activity and the development of post-implant complications
measure: Number of participants with treatment-related adverse events. Change of clinical and coagulation parameters from baseline to 24-months post-implant
time frame: Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE
description: Correlation between coagulation parameters and the development of post-implant complications
measure: Number of participants with treatment-related adverse events. Change of pump working conditions after the device implant
time frame: Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE
description: Correlation between pump working conditions and the development of post-implant complications
measure: Number of participants with treatment-related adverse events. Change of prescribed antithrombotic therapy (anticoagulation and antiplatelet drugs) from baseline to 24 months post-implant
time frame: Through study completion. Specific time-points: 1, 3, 6, 12, 18, and 24 months post-implant and at the occurrence of any AE
description: Correlation between antithrombotic therapy and the development of post-implant complications
arm group label: VAD-implanted patients
description: All patients receiving a VAD implant
arm group label: VAD-patients suffering adverse events (AE)
description: VAD-patients sustaining a thromboembolic/bleeding complication over the course of support
intervention type: Diagnostic Test
intervention name: PAS assay, TGT
description: Evaluation of platelet function
arm group label: VAD-implanted patients
arm group label: VAD-patients suffering adverse events (AE)
Platelet-free-plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Federico Pappalardo, MD
phone: 00390226434524
email: pappalardo.federico@hsr.it
facility: 
status: Recruiting
contact: 
contact backup: 
country: Italy
citation: Valerio L, Consolo F, Bluestein D, Tran P, Slepian M, Redaelli A, Pappalardo F. Shear-mediated platelet activation in patients implanted with continuous flow LVADs: A preliminary study utilizing the platelet activity state (PAS) assay. Annu Int Conf IEEE Eng Med Biol Soc. 2015 Aug;2015:1255-8. doi: 10.1109/EMBC.2015.7318595.
PMID: 26736495
citation: Consolo F, Sheriff J, Gorla S, Magri N, Bluestein D, Pappalardo F, Slepian MJ, Fiore GB, Redaelli A. High Frequency Components of Hemodynamic Shear Stress Profiles are a Major Determinant of Shear-Mediated Platelet Activation in Therapeutic Blood Recirculating Devices. Sci Rep. 2017 Jul 10;7(1):4994. doi: 10.1038/s41598-017-05130-5.
PMID: 28694489
citation: Sheriff J, Girdhar G, Chiu WC, Jesty J, Slepian MJ, Bluestein D. Comparative efficacy of in vitro and in vivo metabolized aspirin in the DeBakey ventricular assist device. J Thromb Thrombolysis. 2014 May;37(4):499-506. doi: 10.1007/s11239-013-0997-6.
PMID: 24043375
citation: Sheriff J, Bluestein D, Girdhar G, Jesty J. High-shear stress sensitizes platelets to subsequent low-shear conditions. Ann Biomed Eng. 2010 Apr;38(4):1442-50. doi: 10.1007/s10439-010-9936-2. Epub 2010 Feb 5.
PMID: 20135353
citation: Jesty J, Bluestein D. Acetylated prothrombin as a substrate in the measurement of the procoagulant activity of platelets: elimination of the feedback activation of platelets by thrombin. Anal Biochem. 1999 Jul 15;272(1):64-70. doi: 10.1006/abio.1999.4148.
PMID: 10405294
citation: Slepian MJ, Sheriff J, Hutchinson M, Tran P, Bajaj N, Garcia JGN, Scott Saavedra S, Bluestein D. Shear-mediated platelet activation in the free flow: Perspectives on the emerging spectrum of cell mechanobiological mechanisms mediating cardiovascular implant thrombosis. J Biomech. 2017 Jan 4;50:20-25. doi: 10.1016/j.jbiomech.2016.11.016. Epub 2016 Nov 10.
PMID: 27887727
citation: Rogers JG, Pagani FD, Tatooles AJ, Bhat G, Slaughter MS, Birks EJ, Boyce SW, Najjar SS, Jeevanandam V, Anderson AS, Gregoric ID, Mallidi H, Leadley K, Aaronson KD, Frazier OH, Milano CA. Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure. N Engl J Med. 2017 Feb 2;376(5):451-460. doi: 10.1056/NEJMoa1602954.
PMID: 28146651
citation: Slaughter MS, Pagani FD, McGee EC, Birks EJ, Cotts WG, Gregoric I, Howard Frazier O, Icenogle T, Najjar SS, Boyce SW, Acker MA, John R, Hathaway DR, Najarian KB, Aaronson KD; HeartWare Bridge to Transplant ADVANCE Trial Investigators. HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial. J Heart Lung Transplant. 2013 Jul;32(7):675-83. doi: 10.1016/j.healun.2013.04.004.
PMID: 23796152
citation: Valerio L, Tran PL, Sheriff J, Brengle W, Ghosh R, Chiu WC, Redaelli A, Fiore GB, Pappalardo F, Bluestein D, Slepian MJ. Aspirin has limited ability to modulate shear-mediated platelet activation associated with elevated shear stress of ventricular assist devices. Thromb Res. 2016 Apr;140:110-117. doi: 10.1016/j.thromres.2016.01.026. Epub 2016 Feb 1.
PMID: 26938158
citation: Consolo F, Sferrazza G, Motolone G, Contri R, Valerio L, Lembo R, Pozzi L, Della Valle P, De Bonis M, Zangrillo A, Fiore GB, Redaelli A, Slepian MJ, Pappalardo F. Platelet activation is a preoperative risk factor for the development of thromboembolic complications in patients with continuous-flow left ventricular assist device. Eur J Heart Fail. 2018 Apr;20(4):792-800. doi: 10.1002/ejhf.1113. Epub 2017 Dec 28.
PMID: 29282819
citation: Consolo F, Pozzi L, Sferrazza G, Della Valle P, D'Angelo A, Slepian MJ, Pappalardo F. Which Antiplatelet Therapy in Patients With Left Ventricular Assist Device and Aspirin Allergy? Ann Thorac Surg. 2018 Feb;105(2):e47-e49. doi: 10.1016/j.athoracsur.2017.09.022.
PMID: 29362190
citation: Consolo F, Sferrazza G, Motolone G, Pieri M, De Bonis M, Zangrillo A, Redaelli A, Slepian MJ, Pappalardo F. Shear-Mediated Platelet Activation Enhances Thrombotic Complications in Patients With LVADs and Is Reversed After Heart Transplantation. ASAIO J. 2019 May/Jun;65(4):e33-e35. doi: 10.1097/MAT.0000000000000842.
PMID: 29952802
responsible party type: Principal Investigator
investigator affiliation: Scientific Institute San Raffaele
investigator full name: Filippo Consolo
investigator title: Assistant Professor
mesh term: Thrombosis
mesh term: Hemostatic Disorders
mesh term: Blood Coagulation Disorders
sharing ipd: No
ipd description: Privacy restrictions