<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/NCT03231787</url>
  </required_header>
  <id_info>
    <org_study_id>IIBSP-PLA-2016-86</org_study_id>
    <nct_id>NCT03231787</nct_id>
  </id_info>
  <brief_title>Clinical Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery</brief_title>
  <acronym>AFFEcT</acronym>
  <official_title>Randomized Parallel Multicenter Trial in Antiaggregated Patients With Proximal Femur Fracture Evaluating a Strategy to Shorten Time Until Surgery (AFFEcT Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Carlos III Health Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Spanish Clinical Research Network - SCReN</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau</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>
      National, randomized, open, parallel, multicenter clinical trial of two comparison groups&#xD;
      that will evaluate the feasibility of a strategy based on a diagnostic test to shorten the&#xD;
      surgery time in antiaggregated patients with proximal femur fracture.&#xD;
&#xD;
      The experimental group will undergo surgery as soon as platelet aggregability, according to&#xD;
      the PLATELETWORKS® method is correct within 24-48 hours.&#xD;
&#xD;
      The control group will undergo surgery according to the usual practice of the center taking&#xD;
      into account the safety time of the antiplatelet agent.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 4, 2017</start_date>
  <completion_date type="Actual">December 17, 2021</completion_date>
  <primary_completion_date type="Actual">November 17, 2021</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time from emergency admission to surgery</measure>
    <time_frame>Up to 120 hours</time_frame>
    <description>Time from emergency admission to surgery will be measured in hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bleeding</measure>
    <time_frame>Through hospitalization, an average of 5 days</time_frame>
    <description>Total blood loss calculated by Nadler's formula from date of surgery until date of discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for blood transfusion</measure>
    <time_frame>Through hospitalization, an average of 5 days</time_frame>
    <description>Need for blood transfusion during hospitalization and transfused units</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative hemoglobin</measure>
    <time_frame>12 hours before surgery</time_frame>
    <description>Measurement of preoperative hemoglobin during 12 h before surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative hemoglobin</measure>
    <time_frame>From 12 hours after surgery until date of discharge, an average of 5 days</time_frame>
    <description>Measurement of postoperative hemoglobin until discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical wound complications</measure>
    <time_frame>1 week and 30 days after surgery</time_frame>
    <description>It includes:&#xD;
Wound infection&#xD;
Wound dehiscence&#xD;
Reoperation due to wound complications&#xD;
Postoperative pain&#xD;
Safety: including the incidence of deep venous thrombosis during admission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical complications</measure>
    <time_frame>1 week and 30 days after surgery</time_frame>
    <description>Myocardial infarction, stroke, pulmonary embolism, pneumonia / respiratory infections, urinary tract infections, sepsis, new onset pressure ulcers, acute renal failure, heart failure, delirium.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelet Functionality</measure>
    <time_frame>From date of admission until the day before surgery, an average of 2 days</time_frame>
    <description>Measurement of platelet functionality with plateletworks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>Preoperative, 5 days after surgery, and 1, 6 and 12 months after surgery</time_frame>
    <description>Quality of life measured by EQ-5D-5L questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to admission to patient movilization</measure>
    <time_frame>From date of admission until the date of first movilization, an average of 3 days</time_frame>
    <description>Time to admission to patient movilization measured in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>1 year</time_frame>
    <description>All causes mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost effectiveness ratio</measure>
    <time_frame>1 year</time_frame>
    <description>Cost effectiveness ratio (Δ cost / Δ effectiveness)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Femur Fracture</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group the platelet aggregability will be evaluated and if it is normal, the surgery will be performed within 24-48 hours.&#xD;
If it is not normal, the evaluation of platelet aggregability will be repeated daily until the third day or until it is normalized if it is earlier.&#xD;
If at the third day is not normalized, it will proceed as with the control group, which will take into account the safety time of the drug.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The control group will wait for the safety time of the drug according to the usual practice of the center.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Platelet function assay</intervention_name>
    <description>Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation or % platelet inhibition.&#xD;
It will be used to measure platelet function after withdrawal of the antiplatelet agent.&#xD;
If there are more than 80,000 functional platelets, the patient will be operated on within the next 24 hours.</description>
    <arm_group_label>Experimental group</arm_group_label>
    <other_name>Plateletworks®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients older than 18 years&#xD;
&#xD;
          -  Patients of both sexes&#xD;
&#xD;
          -  Patients with a proximal femoral fracture requiring surgery&#xD;
&#xD;
          -  Patients receiving antiplatelet agents at the time of admission to the emergency room:&#xD;
             AAS&gt; 100 mg / d (Aspirin®), Trifusal&gt; 300 mg / d (Digren®; Edigen®), clopidogrel&#xD;
             (Plavix®), prasugrel ®), ticagrelor (Brilique ®) and ticlopidine (Tiklid ®).&#xD;
&#xD;
          -  Patients who give their signed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple fractures&#xD;
&#xD;
          -  Pathological fractures&#xD;
&#xD;
          -  Patients receiving vitamin K antagonist oral anticoagulants (warfarin and&#xD;
             acenocoumarol) or new oral anticoagulants (apixaban, rivaroxaban and dabigatran) or&#xD;
             who have acquired congenital or acquired coagulopathy&#xD;
&#xD;
          -  Patients with AAS ≤100mg, trifusal ≤300mg&#xD;
&#xD;
          -  Patients who do not give their informed consent or their legal guardian&#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>Maria J Martinez Zapata, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Althaia, Xarxa Assistencial Universitària de Manresa</name>
      <address>
        <city>Manresa</city>
        <state>Barcelona</state>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de la Santa Creu i Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>January 18, 2023</last_update_submitted>
  <last_update_submitted_qc>January 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Femoral Fractures</mesh_term>
  </condition_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/NCT03231787
org study id: IIBSP-PLA-2016-86
nct id: NCT03231787
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
National, randomized, open, parallel, multicenter clinical trial of two comparison groups
      that will evaluate the feasibility of a strategy based on a diagnostic test to shorten the
      surgery time in antiaggregated patients with proximal femur fracture.

      The experimental group will undergo surgery as soon as platelet aggregability, according to
      the PLATELETWORKS® method is correct within 24-48 hours.

      The control group will undergo surgery according to the usual practice of the center taking
      into account the safety time of the antiplatelet agent.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Time from emergency admission to surgery
time frame: Up to 120 hours
description: Time from emergency admission to surgery will be measured in hours
measure: Bleeding
time frame: Through hospitalization, an average of 5 days
description: Total blood loss calculated by Nadler's formula from date of surgery until date of discharge
measure: Need for blood transfusion
time frame: Through hospitalization, an average of 5 days
description: Need for blood transfusion during hospitalization and transfused units
measure: Preoperative hemoglobin
time frame: 12 hours before surgery
description: Measurement of preoperative hemoglobin during 12 h before surgery
measure: Postoperative hemoglobin
time frame: From 12 hours after surgery until date of discharge, an average of 5 days
description: Measurement of postoperative hemoglobin until discharge
measure: Surgical wound complications
time frame: 1 week and 30 days after surgery
description: It includes:
Wound infection
Wound dehiscence
Reoperation due to wound complications
Postoperative pain
Safety: including the incidence of deep venous thrombosis during admission
measure: Medical complications
time frame: 1 week and 30 days after surgery
description: Myocardial infarction, stroke, pulmonary embolism, pneumonia / respiratory infections, urinary tract infections, sepsis, new onset pressure ulcers, acute renal failure, heart failure, delirium.
measure: Platelet Functionality
time frame: From date of admission until the day before surgery, an average of 2 days
description: Measurement of platelet functionality with plateletworks
measure: Quality of life
time frame: Preoperative, 5 days after surgery, and 1, 6 and 12 months after surgery
description: Quality of life measured by EQ-5D-5L questionnaire
measure: Time to admission to patient movilization
time frame: From date of admission until the date of first movilization, an average of 3 days
description: Time to admission to patient movilization measured in days
measure: Mortality
time frame: 1 year
description: All causes mortality
measure: Cost effectiveness ratio
time frame: 1 year
description: Cost effectiveness ratio (Δ cost / Δ effectiveness)
arm group label: Experimental group
arm group type: Experimental
description: In this group the platelet aggregability will be evaluated and if it is normal, the surgery will be performed within 24-48 hours.
If it is not normal, the evaluation of platelet aggregability will be repeated daily until the third day or until it is normalized if it is earlier.
If at the third day is not normalized, it will proceed as with the control group, which will take into account the safety time of the drug.
arm group label: Control group
arm group type: No Intervention
description: The control group will wait for the safety time of the drug according to the usual practice of the center.
intervention type: Diagnostic Test
intervention name: Platelet function assay
description: Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation or % platelet inhibition.
It will be used to measure platelet function after withdrawal of the antiplatelet agent.
If there are more than 80,000 functional platelets, the patient will be operated on within the next 24 hours.
arm group label: Experimental group
other name: Plateletworks®
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maria J Martinez Zapata, MD, PhD
role: Principal Investigator
affiliation: Institut de Recerca Hospital de la Santa Creu i Sant Pau - IIB Sant Pau
facility: 
facility: 
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Fractures, Bone
mesh term: Femoral Fractures
sharing ipd: Undecided