<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/NCT03249038</url>
  </required_header>
  <id_info>
    <org_study_id>HCB/2016/0906</org_study_id>
    <nct_id>NCT03249038</nct_id>
  </id_info>
  <brief_title>Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.</brief_title>
  <official_title>Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Clinic of Barcelona</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Clinic of Barcelona</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>
      Estimated blood loss is an important parameter recognized as a standard practice in&#xD;
      anesthesiology and others medical specialties, with relevant clinical and research&#xD;
      applications. Currently is no model capable of accurately estimate blood loss. The purpose of&#xD;
      this study is to evaluate the accuracy of a novel model.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">September 1, 2017</completion_date>
  <primary_completion_date type="Actual">August 1, 2017</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Hemoglobin mass lost</measure>
    <time_frame>Intraoperative</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative serum hemoglobin concentration</measure>
    <time_frame>48 hours</time_frame>
  </primary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Blood Loss, Surgical</condition>
  <condition>Blood Loss</condition>
  <condition>Blood Loss, Postoperative</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Measurement of external blood loss</intervention_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Serum Hemoglobin concentration</intervention_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      -  Serum hemoglobin concentration.&#xD;
&#xD;
        -  Hemoglobin concentration of external blood loss.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for elective urologic laparoscopy surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for elective urologic laparoscopy surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with suspected or confirmed heart failure, severe hypertension, hepatic&#xD;
             cirrhosis, chronic kidney disease on dialysis, coagulopathy, as well as patient&#xD;
             receiving diuretics, anticoagulant or antiplatelet agents.&#xD;
&#xD;
          -  Cases in which surgical gauzes were used, including conversion to open surgical&#xD;
             technique. - Patients who have received transfusions of RBCs during the perioperative&#xD;
             period.&#xD;
&#xD;
          -  Patients who have showed postoperative bleeding, defined by an amount greater than 50&#xD;
             ml in surgical drains, or any other type of blood loss.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>September 6, 2017</last_update_submitted>
  <last_update_submitted_qc>September 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Clinic of Barcelona</investigator_affiliation>
    <investigator_full_name>Sebastian Jaramillo</investigator_full_name>
    <investigator_title>Dr. Sebastian Jaramillo</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Blood Loss, Surgical</mesh_term>
    <mesh_term>Postoperative Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chrysarobin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03249038
org study id: HCB/2016/0906
nct id: NCT03249038
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Estimated blood loss is an important parameter recognized as a standard practice in
      anesthesiology and others medical specialties, with relevant clinical and research
      applications. Currently is no model capable of accurately estimate blood loss. The purpose of
      this study is to evaluate the accuracy of a novel model.
observational model: Cohort
time perspective: Prospective
measure: Hemoglobin mass lost
time frame: Intraoperative
measure: Postoperative serum hemoglobin concentration
time frame: 48 hours
intervention type: Other
intervention name: Measurement of external blood loss
intervention type: Diagnostic Test
intervention name: Serum Hemoglobin concentration
-  Serum hemoglobin concentration.

        -  Hemoglobin concentration of external blood loss.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: Hospital Clinic of Barcelona
investigator full name: Sebastian Jaramillo
investigator title: Dr. Sebastian Jaramillo
mesh term: Hemorrhage
mesh term: Blood Loss, Surgical
mesh term: Postoperative Hemorrhage
mesh term: Chrysarobin
sharing ipd: No