<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/NCT01682252</url>
  </required_header>
  <id_info>
    <org_study_id>01201000247</org_study_id>
    <nct_id>NCT01682252</nct_id>
  </id_info>
  <brief_title>Analysis of Blood During Surgery for Musculoskeletal Tumors</brief_title>
  <official_title>Cellular Analysis of Blood Suctioned During Surgery for Musculoskeletal Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is being done as the doctor investigators would like to lessen the amount of blood&#xD;
      transfusions given to patients. Patients who receive blood transfusions have a greater chance&#xD;
      of developing complications after surgery. There is a device called the Cell Saver that&#xD;
      allows the doctors to process blood that is lost during surgery and return it to the patient.&#xD;
      This lessens the amount of transfused blood the patients receive. This device is not used for&#xD;
      patients undergoing surgery for muscular skeletal tumors.The investigators are not sure&#xD;
      whether tumor cells are present in the blood which is lost during the course of an operation&#xD;
      like yours. The goal of this study is to see if we lessen the amount of blood transfusions&#xD;
      given to patients who may have tumor or cancerous cells present in their blood. One way to do&#xD;
      this is to test the blood that is circulating in your veins and also to test the blood which&#xD;
      is lost during the course of your operation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Allogenic Blood transfusions are associated with numerous complications from simple uticaria&#xD;
      to serious transmissible diseases. While improved testing has significantly decreased the&#xD;
      incidence of AIDS and hepatitis C to approximately 1:2,000,000 units tested; hepatitis B&#xD;
      approximately 1:200,000 units tested, more frequent complications occur secondary to&#xD;
      immunomodulation, which results in making infections more common. These are not due to&#xD;
      infected blood, but develop because of changes in patients' immune system after having&#xD;
      received an allogenic red blood cell transfusion. The relative risk for developing an&#xD;
      infection is 1.6 for 1-3 red blood cell units and 3.6 for patients who receive more than 3&#xD;
      red cell units. Patients who receive transfusions have a 52% greater risk of developing&#xD;
      pneumonia and a 35% greater risk of developing a urinary tract infection. On average,&#xD;
      hospitalization costs $14,000 more for patients with a serious infection. These infections&#xD;
      prolong the length of hospitalization after surgery and may even result in death.2 Other&#xD;
      complications of transfusion include Transfusion Related Acute Lung Injury which causes at&#xD;
      least 5300 TRALI reactions per year in the US alone, and approximately 500 deaths. In fact,&#xD;
      just one donor whose blood triggered a TRALI death was found on review of records to have&#xD;
      caused 14 previous cases of TRALI. Other serious complications include Adult Respiratory&#xD;
      Distress Syndrome, and transfusion reactions. As a group, these complications of transfusion&#xD;
      result in increased morbidity and mortality. Therefore, it is in the best interest of&#xD;
      patients to decrease the amount of allogenic blood transfused (from other individuals). To&#xD;
      prevent this, surgeons employ the use of a Cell Saver (CS) during surgery which collects the&#xD;
      patient's own blood from the operative field and washes it. This blood is then re-infused&#xD;
      into the patient's intravenous, minimizing the need for transfusion of blood from the blood&#xD;
      bank.&#xD;
&#xD;
      Despite the benefits of the cell saver, it is not used in patients who have malignancy due to&#xD;
      concern that the tumor cells may spread systemically via the blood. Due to the nature of&#xD;
      musculoskeletal tumor resections there is often significant blood loss. Dissection is&#xD;
      regularly through the muscles rather than around muscular intervals, which can result in&#xD;
      significant bleeding. The goal of this study is to determine the presence or absence of tumor&#xD;
      cells in the blood suctioned from the surgical field. Pending the outcome, consideration will&#xD;
      be made to go forward with a second study to determine if cell saver could be used in&#xD;
      patients with malignancy undergoing surgery.&#xD;
&#xD;
      It is unclear whether tumor cells are present in the blood suctioned from an extremity&#xD;
      malignancy resection. It is also unknown if the processing of blood suctioned would remove&#xD;
      tumor cells from the blood to be transfused. If no tumor cells are found in the blood after&#xD;
      processing then transfusion of this blood would likely be safe. This could result in&#xD;
      decreased blood transfusions in this patient population. This would not only decrease risk to&#xD;
      these patients, it would also improve the blood supply, ensuring that blood is available for&#xD;
      other patients who require it. This work is highly significant as it would both improve&#xD;
      safety in this patient population and improve the blood supply. Data collected will include&#xD;
      the patient's diagnosis, the presence or absence of metastatic disease, whether they have&#xD;
      been previously treated with chemotherapy or radiation and the dates of that treatment.&#xD;
      Patients will undergo surgery and anesthesia in the usual manner. Three sets of specimens&#xD;
      approximately 4mL each would be taken; one from a peripheral line prior to opening the skin,&#xD;
      the second sample will be taken from the surgical field or suction canister during the tumor&#xD;
      resection the third from the surgical field or suction canister shortly before the tumor is&#xD;
      removed. These samples will be taken to Dr. Fitzhugh's laboratory for slide staining.&#xD;
&#xD;
      Patients who are determined by their surgeon and/or anesthesiologist to require blood will be&#xD;
      administered blood processed by the University Hospital Blood Bank using standard transfusion&#xD;
      protocols. No blood taken from the patient or the operative field will be transfused.&#xD;
&#xD;
      There are no significant risks in this study. Roughly 2 ml of blood is required for the total&#xD;
      number of slides (2-4) that would be prepared per tube. This amount of blood 12 mL is less&#xD;
      than one tablespoon and does not pose significant risk to the patient nor does it increase&#xD;
      the likelihood of transfusion. Slides will be stained using the Diff-Quik staining method, a&#xD;
      method similar to the Wright-Giemsa staining used in hematology laboratories. The technique&#xD;
      is rapid (requires only 3 minutes per submitted sample) and inexpensive. Slides will be&#xD;
      reviewed by Dr. Fitzhugh.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    investigators felt sufficient data has been collected&#xD;
  </why_stopped>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>presence of tumor cells in the operative field</measure>
    <time_frame>intraoperatively</time_frame>
    <description>specimens taken twice from operative field; once just prior to removal of tumor and the second just after tumor removal.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">34</enrollment>
  <condition>Musculoskeletal Tumors</condition>
  <arm_group>
    <arm_group_label>musculoskeletal tumors</arm_group_label>
    <description>all patients undergoing surgery for musculoskeletal tumors</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        all patients undergoing orthopedic surgery for remival of musculoskeletal tumors under&#xD;
        general anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients undergoing orthopedic surgery for musculoskeletal tumors&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pts who are pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuriy Gubenko, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMDNJ/NJMS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>February 8, 2016</last_update_submitted>
  <last_update_submitted_qc>February 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
    <investigator_full_name>Anesthesia</investigator_full_name>
    <investigator_title>Yuriy Gubenko, MD Assistant Professor</investigator_title>
  </responsible_party>
  <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/NCT01682252
org study id: 01201000247
nct id: NCT01682252
lead sponsor: 
has dmc: No
This study is being done as the doctor investigators would like to lessen the amount of blood
      transfusions given to patients. Patients who receive blood transfusions have a greater chance
      of developing complications after surgery. There is a device called the Cell Saver that
      allows the doctors to process blood that is lost during surgery and return it to the patient.
      This lessens the amount of transfused blood the patients receive. This device is not used for
      patients undergoing surgery for muscular skeletal tumors.The investigators are not sure
      whether tumor cells are present in the blood which is lost during the course of an operation
      like yours. The goal of this study is to see if we lessen the amount of blood transfusions
      given to patients who may have tumor or cancerous cells present in their blood. One way to do
      this is to test the blood that is circulating in your veins and also to test the blood which
      is lost during the course of your operation
Allogenic Blood transfusions are associated with numerous complications from simple uticaria
      to serious transmissible diseases. While improved testing has significantly decreased the
      incidence of AIDS and hepatitis C to approximately 1:2,000,000 units tested; hepatitis B
      approximately 1:200,000 units tested, more frequent complications occur secondary to
      immunomodulation, which results in making infections more common. These are not due to
      infected blood, but develop because of changes in patients' immune system after having
      received an allogenic red blood cell transfusion. The relative risk for developing an
      infection is 1.6 for 1-3 red blood cell units and 3.6 for patients who receive more than 3
      red cell units. Patients who receive transfusions have a 52% greater risk of developing
      pneumonia and a 35% greater risk of developing a urinary tract infection. On average,
      hospitalization costs $14,000 more for patients with a serious infection. These infections
      prolong the length of hospitalization after surgery and may even result in death.2 Other
      complications of transfusion include Transfusion Related Acute Lung Injury which causes at
      least 5300 TRALI reactions per year in the US alone, and approximately 500 deaths. In fact,
      just one donor whose blood triggered a TRALI death was found on review of records to have
      caused 14 previous cases of TRALI. Other serious complications include Adult Respiratory
      Distress Syndrome, and transfusion reactions. As a group, these complications of transfusion
      result in increased morbidity and mortality. Therefore, it is in the best interest of
      patients to decrease the amount of allogenic blood transfused (from other individuals). To
      prevent this, surgeons employ the use of a Cell Saver (CS) during surgery which collects the
      patient's own blood from the operative field and washes it. This blood is then re-infused
      into the patient's intravenous, minimizing the need for transfusion of blood from the blood
      bank.

      Despite the benefits of the cell saver, it is not used in patients who have malignancy due to
      concern that the tumor cells may spread systemically via the blood. Due to the nature of
      musculoskeletal tumor resections there is often significant blood loss. Dissection is
      regularly through the muscles rather than around muscular intervals, which can result in
      significant bleeding. The goal of this study is to determine the presence or absence of tumor
      cells in the blood suctioned from the surgical field. Pending the outcome, consideration will
      be made to go forward with a second study to determine if cell saver could be used in
      patients with malignancy undergoing surgery.

      It is unclear whether tumor cells are present in the blood suctioned from an extremity
      malignancy resection. It is also unknown if the processing of blood suctioned would remove
      tumor cells from the blood to be transfused. If no tumor cells are found in the blood after
      processing then transfusion of this blood would likely be safe. This could result in
      decreased blood transfusions in this patient population. This would not only decrease risk to
      these patients, it would also improve the blood supply, ensuring that blood is available for
      other patients who require it. This work is highly significant as it would both improve
      safety in this patient population and improve the blood supply. Data collected will include
      the patient's diagnosis, the presence or absence of metastatic disease, whether they have
      been previously treated with chemotherapy or radiation and the dates of that treatment.
      Patients will undergo surgery and anesthesia in the usual manner. Three sets of specimens
      approximately 4mL each would be taken; one from a peripheral line prior to opening the skin,
      the second sample will be taken from the surgical field or suction canister during the tumor
      resection the third from the surgical field or suction canister shortly before the tumor is
      removed. These samples will be taken to Dr. Fitzhugh's laboratory for slide staining.

      Patients who are determined by their surgeon and/or anesthesiologist to require blood will be
      administered blood processed by the University Hospital Blood Bank using standard transfusion
      protocols. No blood taken from the patient or the operative field will be transfused.

      There are no significant risks in this study. Roughly 2 ml of blood is required for the total
      number of slides (2-4) that would be prepared per tube. This amount of blood 12 mL is less
      than one tablespoon and does not pose significant risk to the patient nor does it increase
      the likelihood of transfusion. Slides will be stained using the Diff-Quik staining method, a
      method similar to the Wright-Giemsa staining used in hematology laboratories. The technique
      is rapid (requires only 3 minutes per submitted sample) and inexpensive. Slides will be
      reviewed by Dr. Fitzhugh.
time perspective: Prospective
measure: presence of tumor cells in the operative field
time frame: intraoperatively
description: specimens taken twice from operative field; once just prior to removal of tumor and the second just after tumor removal.
arm group label: musculoskeletal tumors
description: all patients undergoing surgery for musculoskeletal tumors
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Yuriy Gubenko, MD
role: Principal Investigator
affiliation: UMDNJ/NJMS
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rutgers, The State University of New Jersey
investigator full name: Anesthesia
investigator title: Yuriy Gubenko, MD Assistant Professor
sharing ipd: No