<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/NCT03765372</url>
  </required_header>
  <id_info>
    <org_study_id>BiPoC</org_study_id>
    <nct_id>NCT03765372</nct_id>
  </id_info>
  <brief_title>Evaluation of BIomarkers for POstoperative Complications in Non-cardiac Surgery Patients</brief_title>
  <official_title>Evaluation of IPF, hsTnT and Pro-BNP as Biomarkers for Perioperative Risk Stratification Among Patients Undergoing Elective Non-cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technical University of Munich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technical University of Munich</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>
      Aim of this study is to evaluate whether IPF, hsTnT and NT pro-BNP can be used as biomarkers&#xD;
      for perioperative risk stratification predicting postoperative complications in patients&#xD;
      undergoing elective non-cardiac surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Immature platelets (IPF), high sensitive Troponin T (hsTnT) and NTpro-BNP are associated with&#xD;
      major adverse cardiovascular events (MACE), myocardial injury after noncardiac surgery (MINS)&#xD;
      and mortality. This study is designed to investigate whether the biomarkers IPF, hsTnT and&#xD;
      NTpro-BNP can predict postoperative complications assessed by the Clavien-Dindo&#xD;
      classification. Patients are screened for participation in the SUPERADD study (NCT03167656)&#xD;
      and who gave written informed consent are included in this study. The biomarkers are analysed&#xD;
      before induction of anaesthesia and at the PACU (postoperative anaesthesia care unit) next to&#xD;
      other labaratory parameters. Further during preanaesthesia visit all relevant comorbidities.&#xD;
      the ASA (American Society of Anesthesiology)-Status, the POSPOM (Preoperative Score to&#xD;
      Predict Postoperative Mortality) and the CCI (Charlson Comobidity Index) are obtained.&#xD;
      Intraoperative parameters like blood pressure, heart rate, estimated blood loss are measured&#xD;
      and complications in the PACU are recorded. Primary Endpoint are postoperative complications&#xD;
      assessed with the Cavien-Dindo classification ≥ 2. For each biomarker three ROC curves&#xD;
      (preoperative value, postoperative value and the difference between pre- to postoperative&#xD;
      value) are obtained and the respective AUC determined. The association of each biomarker and&#xD;
      the combination of the biomarkers are tested using regession analyses.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 19, 2017</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>postoperative complications determined with the calvien-dindo classification</measure>
    <time_frame>date of surgery until hospital discharge (approx. 30 days)</time_frame>
    <description>Pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound, haematological and pain. Each domain is graded between grade I and V (death of a patient).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>hospital mortality</measure>
    <time_frame>date of surgery until hospital discharge (approx. 30 days)</time_frame>
    <description>Rate of Mortality among study patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 months mortalitiy</measure>
    <time_frame>date of surgery until 6 months after</time_frame>
    <description>Rate of Mortality among study patients</description>
  </secondary_outcome>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Perioperative/Postoperative Complications</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        High risk patients (ASA Status 3 or 4) and / or patients undergoing elective non-cardiac&#xD;
        high risk surgery at the Klinikum rechts der Isar, Munich.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written informed consense&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  ASA Score 3 or 4&#xD;
&#xD;
          -  elective non-cardiac high risk surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  need for dialysis&#xD;
&#xD;
          -  liver cirrhosis child C&#xD;
&#xD;
          -  intolerance of albumin&#xD;
&#xD;
          -  participation in other AMG (medicines law) study&#xD;
&#xD;
          -  pregnancy or breastfeeding&#xD;
&#xD;
          -  patients with attendants concerning medical matters&#xD;
&#xD;
          -  ASA V patients&#xD;
&#xD;
          -  patients with BMI &gt; 35 kg/m2&#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>Bettina Jungwirth, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Anesthesia, Klinikum rechts der Isar, TU Munich</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum Rechts der Isar, Technische Universität München</name>
      <address>
        <city>München</city>
        <state>Bavaria</state>
        <zip>81675</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Anetsberger A, Blobner M, Haller B, Schmid S, Umgelter K, Hager T, Langgartner C, Kochs EF, Laugwitz KL, Jungwirth B, Bernlochner I. Immature platelets as a novel biomarker for adverse cardiovascular events in patients after non-cardiac surgery. Thromb Haemost. 2017 Oct 5;117(10):1887-1895. doi: 10.1160/TH16-10-0804. Epub 2017 Aug 10.</citation>
    <PMID>28796275</PMID>
  </results_reference>
  <results_reference>
    <citation>Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.</citation>
    <PMID>28444280</PMID>
  </results_reference>
  <results_reference>
    <citation>Ma J, Xin Q, Wang X, Gao M, Wang Y, Liu J. Prediction of perioperative cardiac events through preoperative NT-pro-BNP and cTnI after emergent non-cardiac surgery in elderly patients. PLoS One. 2015 Mar 23;10(3):e0121306. doi: 10.1371/journal.pone.0121306. eCollection 2015.</citation>
    <PMID>25799524</PMID>
  </results_reference>
  <results_reference>
    <citation>Vetrugno L, Costa MG, Pompei L, Chiarandini P, Drigo D, Bassi F, Gonano N, Muzzi R, Della Rocca G. Prognostic power of pre- and postoperative B-type natriuretic peptide levels in patients undergoing abdominal aortic surgery. J Cardiothorac Vasc Anesth. 2012 Aug;26(4):637-42. doi: 10.1053/j.jvca.2012.01.018. Epub 2012 Mar 2.</citation>
    <PMID>22387082</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>perioperative outcome</keyword>
  <keyword>clavien-dindo classification</keyword>
  <keyword>IPF</keyword>
  <keyword>hsTnT</keyword>
  <keyword>proBNP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_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/NCT03765372
org study id: BiPoC
nct id: NCT03765372
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim of this study is to evaluate whether IPF, hsTnT and NT pro-BNP can be used as biomarkers
      for perioperative risk stratification predicting postoperative complications in patients
      undergoing elective non-cardiac surgery.
Immature platelets (IPF), high sensitive Troponin T (hsTnT) and NTpro-BNP are associated with
      major adverse cardiovascular events (MACE), myocardial injury after noncardiac surgery (MINS)
      and mortality. This study is designed to investigate whether the biomarkers IPF, hsTnT and
      NTpro-BNP can predict postoperative complications assessed by the Clavien-Dindo
      classification. Patients are screened for participation in the SUPERADD study (NCT03167656)
      and who gave written informed consent are included in this study. The biomarkers are analysed
      before induction of anaesthesia and at the PACU (postoperative anaesthesia care unit) next to
      other labaratory parameters. Further during preanaesthesia visit all relevant comorbidities.
      the ASA (American Society of Anesthesiology)-Status, the POSPOM (Preoperative Score to
      Predict Postoperative Mortality) and the CCI (Charlson Comobidity Index) are obtained.
      Intraoperative parameters like blood pressure, heart rate, estimated blood loss are measured
      and complications in the PACU are recorded. Primary Endpoint are postoperative complications
      assessed with the Cavien-Dindo classification ≥ 2. For each biomarker three ROC curves
      (preoperative value, postoperative value and the difference between pre- to postoperative
      value) are obtained and the respective AUC determined. The association of each biomarker and
      the combination of the biomarkers are tested using regession analyses.
observational model: Other
time perspective: Prospective
measure: postoperative complications determined with the calvien-dindo classification
time frame: date of surgery until hospital discharge (approx. 30 days)
description: Pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, wound, haematological and pain. Each domain is graded between grade I and V (death of a patient).
measure: hospital mortality
time frame: date of surgery until hospital discharge (approx. 30 days)
description: Rate of Mortality among study patients
measure: 6 months mortalitiy
time frame: date of surgery until 6 months after
description: Rate of Mortality among study patients
blood
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bettina Jungwirth, Prof.
role: Study Director
affiliation: Department of Anesthesia, Klinikum rechts der Isar, TU Munich
facility: 
country: Germany
citation: Anetsberger A, Blobner M, Haller B, Schmid S, Umgelter K, Hager T, Langgartner C, Kochs EF, Laugwitz KL, Jungwirth B, Bernlochner I. Immature platelets as a novel biomarker for adverse cardiovascular events in patients after non-cardiac surgery. Thromb Haemost. 2017 Oct 5;117(10):1887-1895. doi: 10.1160/TH16-10-0804. Epub 2017 Aug 10.
PMID: 28796275
citation: Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.
PMID: 28444280
citation: Ma J, Xin Q, Wang X, Gao M, Wang Y, Liu J. Prediction of perioperative cardiac events through preoperative NT-pro-BNP and cTnI after emergent non-cardiac surgery in elderly patients. PLoS One. 2015 Mar 23;10(3):e0121306. doi: 10.1371/journal.pone.0121306. eCollection 2015.
PMID: 25799524
citation: Vetrugno L, Costa MG, Pompei L, Chiarandini P, Drigo D, Bassi F, Gonano N, Muzzi R, Della Rocca G. Prognostic power of pre- and postoperative B-type natriuretic peptide levels in patients undergoing abdominal aortic surgery. J Cardiothorac Vasc Anesth. 2012 Aug;26(4):637-42. doi: 10.1053/j.jvca.2012.01.018. Epub 2012 Mar 2.
PMID: 22387082
responsible party type: Sponsor
mesh term: Postoperative Complications