<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/NCT03282201</url>
  </required_header>
  <id_info>
    <org_study_id>TransfusionArthroplasty</org_study_id>
    <nct_id>NCT03282201</nct_id>
  </id_info>
  <brief_title>A Survey on Blood Transfusions in Major Artrhoplasty Operations</brief_title>
  <official_title>The Effect of Blood Transfusion on Recovery After Major Arthroplasties</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Diskapi Teaching and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Diskapi Teaching and Research Hospital</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>
      The rate of hip, knee arthroplasties and their revision are increasing every year. The&#xD;
      incidence of blood transfusion in these operations are reported 18%, 68%, and 39%, 67%,&#xD;
      respectively. Blood transfusion is known to increase the risk of pulmonary, septic, wound and&#xD;
      thromboembolic complications and is related to mortality. Restrictive transfusion protocols&#xD;
      has cost-effective results in terms of reducing these complications, promoting early&#xD;
      discharge and reduced frequency of re-admission.&#xD;
&#xD;
      Within this context, we aimed to evaluate the transfusion practice in our hospital, define&#xD;
      the transfusion indicators and compare the transfused and non transfused patients in terms of&#xD;
      recovery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After obtaining ethical approval Patients undergoing hip or knee arthroplasty or revision&#xD;
      arthroplasty will be included in this prospective observational study.&#xD;
&#xD;
      Patient characteristics (age , gender, body mass index, ASA physical status, anticoagulant&#xD;
      medication) Preoperative: hemoglobin, hematocrit, platelet, INR, APTT, PT values, the&#xD;
      precence of preoperative anemia, anemia treatment modalities will be recorded.&#xD;
&#xD;
      Intraopreative: type and duration of surgery, anesthesia method, monitoring methods used, the&#xD;
      amount of intraoprative adminestred fluids (crystalloid-colloid), amount of hemorrhage&#xD;
      Postoperative: hemoglobin-hematocrit-platelet leve The amount of blood transfusion and the&#xD;
      product used (erythrocyte suspension, fresh frozen plasma, thrombocyte-fibrinogen-factor&#xD;
      concentration-cryoprecipitate-other ) Hemoglobin-hematocrit-platelet level before and after&#xD;
      transfusion Indications for transfusion; hemoglobin threshold / physiological transfusion&#xD;
      indicator; tachycardia, hypotension, low flow rate, desaturation, low SvO2, inotropic&#xD;
      requirement, etc. / comorbidities / monitorisation findings, other, Discharge time of&#xD;
      patients Early upright position (postoperative 2nd day), information on walking capacities&#xD;
      (TUG - The Time Up and Go test) will be recorded and compared between transfused and&#xD;
      non-transfused patients&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 15, 2017</start_date>
  <completion_date type="Actual">June 20, 2018</completion_date>
  <primary_completion_date type="Actual">May 25, 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Discharge time</measure>
    <time_frame>Postoperative day 1-6 days</time_frame>
    <description>Discharge time from hospital</description>
  </primary_outcome>
  <primary_outcome>
    <measure>TUG test</measure>
    <time_frame>Postoperative day 1-2</time_frame>
    <description>Walking without help</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">418</enrollment>
  <condition>Arthropathy of Hip</condition>
  <condition>Arthropathy of Knee</condition>
  <arm_group>
    <arm_group_label>Transfused</arm_group_label>
    <description>Patients in whom blood transfusion is used</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nontransfused</arm_group_label>
    <description>Patients in whom blood transfusion is not used</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transfusion</intervention_name>
    <description>Transfusion of red blood cells, fresh frozen plasma, platelets</description>
    <arm_group_label>Transfused</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing major atrhroplasty&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing major atrhroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pediatric patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dilek Yazicioglu, Assoc Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ministry of Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diskapi Yildirim Beyazit Teaching and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06110</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Poitras S, Wood KS, Savard J, Dervin GF, Beaule PE. Predicting early clinical function after hip or knee arthroplasty. Bone Joint Res. 2015 Sep;4(9):145-51. doi: 10.1302/2046-3758.49.2000417.</citation>
    <PMID>26336897</PMID>
  </reference>
  <reference>
    <citation>Cram P, Vaughan-Sarrazin MS, Wolf B, Katz JN, Rosenthal GE. A comparison of total hip and knee replacement in specialty and general hospitals. J Bone Joint Surg Am. 2007 Aug;89(8):1675-84. doi: 10.2106/JBJS.F.00873.</citation>
    <PMID>17671004</PMID>
  </reference>
  <results_reference>
    <citation>Engoren M, Mitchell E, Perring P, Sferra J. The effect of erythrocyte blood transfusions on survival after surgery for hip fracture. J Trauma. 2008 Dec;65(6):1411-5. doi: 10.1097/TA.0b013e318157d9f9.</citation>
    <PMID>19077635</PMID>
  </results_reference>
  <results_reference>
    <citation>Kotze A, Carter LA, Scally AJ. Effect of a patient blood management programme on preoperative anaemia, transfusion rate, and outcome after primary hip or knee arthroplasty: a quality improvement cycle. Br J Anaesth. 2012 Jun;108(6):943-52. doi: 10.1093/bja/aes135.</citation>
    <PMID>22593128</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 12, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>November 1, 2018</last_update_submitted>
  <last_update_submitted_qc>November 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Diskapi Teaching and Research Hospital</investigator_affiliation>
    <investigator_full_name>DILEK YAZICIOGLU</investigator_full_name>
    <investigator_title>Associate Proffesor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Joint Diseases</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/NCT03282201
org study id: TransfusionArthroplasty
nct id: NCT03282201
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The rate of hip, knee arthroplasties and their revision are increasing every year. The
      incidence of blood transfusion in these operations are reported 18%, 68%, and 39%, 67%,
      respectively. Blood transfusion is known to increase the risk of pulmonary, septic, wound and
      thromboembolic complications and is related to mortality. Restrictive transfusion protocols
      has cost-effective results in terms of reducing these complications, promoting early
      discharge and reduced frequency of re-admission.

      Within this context, we aimed to evaluate the transfusion practice in our hospital, define
      the transfusion indicators and compare the transfused and non transfused patients in terms of
      recovery.
After obtaining ethical approval Patients undergoing hip or knee arthroplasty or revision
      arthroplasty will be included in this prospective observational study.

      Patient characteristics (age , gender, body mass index, ASA physical status, anticoagulant
      medication) Preoperative: hemoglobin, hematocrit, platelet, INR, APTT, PT values, the
      precence of preoperative anemia, anemia treatment modalities will be recorded.

      Intraopreative: type and duration of surgery, anesthesia method, monitoring methods used, the
      amount of intraoprative adminestred fluids (crystalloid-colloid), amount of hemorrhage
      Postoperative: hemoglobin-hematocrit-platelet leve The amount of blood transfusion and the
      product used (erythrocyte suspension, fresh frozen plasma, thrombocyte-fibrinogen-factor
      concentration-cryoprecipitate-other ) Hemoglobin-hematocrit-platelet level before and after
      transfusion Indications for transfusion; hemoglobin threshold / physiological transfusion
      indicator; tachycardia, hypotension, low flow rate, desaturation, low SvO2, inotropic
      requirement, etc. / comorbidities / monitorisation findings, other, Discharge time of
      patients Early upright position (postoperative 2nd day), information on walking capacities
      (TUG - The Time Up and Go test) will be recorded and compared between transfused and
      non-transfused patients
observational model: Other
time perspective: Prospective
measure: Discharge time
time frame: Postoperative day 1-6 days
description: Discharge time from hospital
measure: TUG test
time frame: Postoperative day 1-2
description: Walking without help
arm group label: Transfused
description: Patients in whom blood transfusion is used
arm group label: Nontransfused
description: Patients in whom blood transfusion is not used
intervention type: Other
intervention name: Transfusion
description: Transfusion of red blood cells, fresh frozen plasma, platelets
arm group label: Transfused
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: Dilek Yazicioglu, Assoc Prof
role: Principal Investigator
affiliation: Ministry of Health
facility: 
country: Turkey
citation: Poitras S, Wood KS, Savard J, Dervin GF, Beaule PE. Predicting early clinical function after hip or knee arthroplasty. Bone Joint Res. 2015 Sep;4(9):145-51. doi: 10.1302/2046-3758.49.2000417.
PMID: 26336897
citation: Cram P, Vaughan-Sarrazin MS, Wolf B, Katz JN, Rosenthal GE. A comparison of total hip and knee replacement in specialty and general hospitals. J Bone Joint Surg Am. 2007 Aug;89(8):1675-84. doi: 10.2106/JBJS.F.00873.
PMID: 17671004
citation: Engoren M, Mitchell E, Perring P, Sferra J. The effect of erythrocyte blood transfusions on survival after surgery for hip fracture. J Trauma. 2008 Dec;65(6):1411-5. doi: 10.1097/TA.0b013e318157d9f9.
PMID: 19077635
citation: Kotze A, Carter LA, Scally AJ. Effect of a patient blood management programme on preoperative anaemia, transfusion rate, and outcome after primary hip or knee arthroplasty: a quality improvement cycle. Br J Anaesth. 2012 Jun;108(6):943-52. doi: 10.1093/bja/aes135.
PMID: 22593128
responsible party type: Principal Investigator
investigator affiliation: Diskapi Teaching and Research Hospital
investigator full name: DILEK YAZICIOGLU
investigator title: Associate Proffesor
mesh term: Joint Diseases
sharing ipd: Undecided