<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/NCT01725724</url>
  </required_header>
  <id_info>
    <org_study_id>2009/763</org_study_id>
    <nct_id>NCT01725724</nct_id>
  </id_info>
  <brief_title>Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients</brief_title>
  <official_title>Effects of the Sangvia Blood Collection System on Postoperative Infections in Orthopedic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Dentsply Sirona Implants and Consumables</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Haukeland University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the infection rate in patients receiving/not&#xD;
      receiving their own blood, collected during surgery, during and after orthopedic surgery.&#xD;
&#xD;
      The hypothesis is that transfusion of autologous salvaged blood may reduce postoperative&#xD;
      infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative infections (both systemic and wound infections) are complications that should&#xD;
      be avoided both due to the discomfort and the risk to the patients and for the corresponding&#xD;
      increment of hospital costs.&#xD;
&#xD;
      There are some studies indicating that transfusion of autologous salvaged blood may reduce&#xD;
      postoperative infections. This may be due to immunostimulating cytokines released in these&#xD;
      products. However, as these cytokines also may cause adverse events as febrile transfusion&#xD;
      reactions and activation of the complement and the coagulation cascades, the overall impact&#xD;
      may be different.&#xD;
&#xD;
      There are two publications from an Austrian group indicating that allogeneic blood&#xD;
      transfusion in orthopedic patients cause increased postoperative infection rate&#xD;
      irrespectively of the leukocyte content of the red cell concentrates.&#xD;
&#xD;
      The Austrian studies were not randomized. Therefore, it would be useful to perform a&#xD;
      randomized, prospective study where the patients receive transfusion of salvaged blood versus&#xD;
      allogeneic red cell concentrate as their primary replacement product, respectively.&#xD;
&#xD;
      The purpose of the pilot study is to evaluate if transfusion of autologous salvaged blood&#xD;
      reduces the infection rate in orthopedic patients compared with patients receiving allogeneic&#xD;
      blood transfusion. The study is limited to one source of autologous blood; blood collected by&#xD;
      the Sangvia Blood Collection System, and the study is partially sponsored by the&#xD;
      manufacturer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2009</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Body temperature</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 8 days.</time_frame>
    <description>The body temperature is measured as a part of infection monitoring.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>C-reactive protein (CRP)</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 8 days.</time_frame>
    <description>CRP i measured as a part of infection monitoring. Because elevated CRP is expected after surgery it is necessary to measure other parameters to in order to monitor infection.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>White blood cells (WBC)</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 8 days.</time_frame>
    <description>WBC is measured and is a part of the infection monitoring.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Coxarthrosis</condition>
  <arm_group>
    <arm_group_label>Allogeneic blood</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Allogeneic blood transfusion. Patients in this group will receive allogeneic red cell transfusions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Autologous blood</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Autologous blood transfusion. Patients in this arm will receive per- and postoperatively collected autologous blood collected with the Sangvia Blood Collection System. If teh amount of autologous blood is too small for the clinical need, additional allogeneic blood will be transfused.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Autologous blood transfusion</intervention_name>
    <description>Per- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System.</description>
    <arm_group_label>Autologous blood</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Allogeneic blood transfusion</intervention_name>
    <description>Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals.</description>
    <arm_group_label>Allogeneic blood</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a risk of needing red cell transfusion after surgery estimated to be&#xD;
             above 75%, judged by preoperative hemoglobin concentration and known risk of&#xD;
             preoperative bleeding&#xD;
&#xD;
          -  Patients over 16 years of age&#xD;
&#xD;
          -  Patients who have consented to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a known hemolytic anemia (congenital or acquired)&#xD;
&#xD;
          -  Patients for whom informed consent has not been obtained&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tor A Hervig, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haukealnd University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kysthospitalet i Hagevik</name>
      <address>
        <city>Hagavik</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soerlandet hospital</name>
      <address>
        <city>Kristiansand</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stord Hospital</name>
      <address>
        <city>Stord</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>April 17, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>March 27, 2015</last_update_submitted>
  <last_update_submitted_qc>March 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Autologous blood transfusion</keyword>
  <keyword>Allogeneic blood transfusion</keyword>
  <keyword>Infection rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Osteoarthritis, Hip</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/NCT01725724
org study id: 2009/763
nct id: NCT01725724
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare the infection rate in patients receiving/not
      receiving their own blood, collected during surgery, during and after orthopedic surgery.

      The hypothesis is that transfusion of autologous salvaged blood may reduce postoperative
      infection.
Postoperative infections (both systemic and wound infections) are complications that should
      be avoided both due to the discomfort and the risk to the patients and for the corresponding
      increment of hospital costs.

      There are some studies indicating that transfusion of autologous salvaged blood may reduce
      postoperative infections. This may be due to immunostimulating cytokines released in these
      products. However, as these cytokines also may cause adverse events as febrile transfusion
      reactions and activation of the complement and the coagulation cascades, the overall impact
      may be different.

      There are two publications from an Austrian group indicating that allogeneic blood
      transfusion in orthopedic patients cause increased postoperative infection rate
      irrespectively of the leukocyte content of the red cell concentrates.

      The Austrian studies were not randomized. Therefore, it would be useful to perform a
      randomized, prospective study where the patients receive transfusion of salvaged blood versus
      allogeneic red cell concentrate as their primary replacement product, respectively.

      The purpose of the pilot study is to evaluate if transfusion of autologous salvaged blood
      reduces the infection rate in orthopedic patients compared with patients receiving allogeneic
      blood transfusion. The study is limited to one source of autologous blood; blood collected by
      the Sangvia Blood Collection System, and the study is partially sponsored by the
      manufacturer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Body temperature
time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
description: The body temperature is measured as a part of infection monitoring.
measure: C-reactive protein (CRP)
time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
description: CRP i measured as a part of infection monitoring. Because elevated CRP is expected after surgery it is necessary to measure other parameters to in order to monitor infection.
measure: White blood cells (WBC)
time frame: Participants will be followed for the duration of hospital stay, an expected average of 8 days.
description: WBC is measured and is a part of the infection monitoring.
arm group label: Allogeneic blood
arm group type: Active Comparator
description: Allogeneic blood transfusion. Patients in this group will receive allogeneic red cell transfusions.
arm group label: Autologous blood
arm group type: Experimental
description: Autologous blood transfusion. Patients in this arm will receive per- and postoperatively collected autologous blood collected with the Sangvia Blood Collection System. If teh amount of autologous blood is too small for the clinical need, additional allogeneic blood will be transfused.
intervention type: Procedure
intervention name: Autologous blood transfusion
description: Per- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System.
arm group label: Autologous blood
intervention type: Procedure
intervention name: Allogeneic blood transfusion
description: Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals.
arm group label: Allogeneic blood
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Tor A Hervig, MD, PhD
role: Principal Investigator
affiliation: Haukealnd University Hospital
facility: 
facility: 
facility: 
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Infections
mesh term: Osteoarthritis, Hip