<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/NCT01716923</url>
  </required_header>
  <id_info>
    <org_study_id>CLI 00070</org_study_id>
    <nct_id>NCT01716923</nct_id>
  </id_info>
  <brief_title>Study to Assess S303 RBCs and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia</brief_title>
  <official_title>A Randomized Controlled Double-Blind Phase 3 Study to Assess Characteristics of S 303 Treated RBC Components and Evaluate Safety and Efficacy in Patients Requiring Transfusion Support of Acute Anemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cerus Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cerus Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The clinical study will assess the in-vitro characteristics of red blood cells (RBCs) per the&#xD;
      European Union (EU) criteria for leukocyte depleted RBCs in additive solution and evaluate&#xD;
      the safety and efficacy of S-303 treated RBCs in a patient population requiring RBC&#xD;
      transfusion support for acute anemia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2013</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 3</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>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Efficacy Endpoint - mean hemoglobin content</measure>
    <time_frame>Day 2</time_frame>
    <description>The mean hemoglobin content per red blood cell (RBC) component compared between the treatment groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Safety Endpoint - Adverse events</measure>
    <time_frame>90 days</time_frame>
    <description>The frequency of adverse events (related and unrelated to study RBC components) will be compared between the treatment groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint</measure>
    <time_frame>Day 35</time_frame>
    <description>Proportion of RBC components that have adenosine-5'-triphosphate (ATP) levels of greater than 2 μmol/L</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint</measure>
    <time_frame>Day 35</time_frame>
    <description>Proportion of RBC components that meet the European Union (EU) guideline for hemoglobin content, hematocrit, and hemolysis at the end of storage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Efficacy Endpoint</measure>
    <time_frame>Day 35</time_frame>
    <description>Proportion of RBC components that have plasma-free hemoglobin levels corresponding to ≤ 0.8% hemolysis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory Endpoint - incidence of renal insufficiency</measure>
    <time_frame>Daily on days 0 through 6</time_frame>
    <description>Incidence of renal insufficiency, indicated by serum creatinine level &gt;2 mg/dL WITH at least a 50% increase from pre-operative baseline OR a new requirement for therapy to treat renal insufficiency (dialysis)</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory Endpoint - incidence of hepatic insufficiency</measure>
    <time_frame>Daily on days 0 through 6</time_frame>
    <description>Incidence of hepatic insufficiency, indicated by total bilirubin that is &gt;2 times the upper limit of normal AND represents at least a 50% increase from the preoperative baseline</description>
  </other_outcome>
  <other_outcome>
    <measure>Exploratory endpoint - Cardiopulmonary function</measure>
    <time_frame>Day 7 and 13</time_frame>
    <description>Cardiopulmonary function at the time of first ambulation and at the time of discharge, as measured by a standardized 6 Minute Walk Test (6MWT)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Focus:Use of S303 RBCs in Patients With Acute Anemia</condition>
  <arm_group>
    <arm_group_label>S-303 Treated Red Blood Cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive S-303 treated red blood cells (RBCs).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional, untreated Red Blood Cells</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive conventional, untreated red blood cells (RBCs).</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>S-303 Red Blood Cells (RBCs) - Test</intervention_name>
    <arm_group_label>S-303 Treated Red Blood Cells</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Conventional, untreated red blood cells (RBCs) - Control</intervention_name>
    <arm_group_label>Conventional, untreated Red Blood Cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years, of either gender.&#xD;
&#xD;
          2. Must be willing to use an acceptable form of contraceptive while on study (as approved&#xD;
             by the Investigator or designee)&#xD;
&#xD;
          3. Must be readily available by telephone&#xD;
&#xD;
          4. Must provide an informed consent for study participation and have signed an ethics&#xD;
             committee (EC)-approved informed consent&#xD;
&#xD;
          5. Must have a negative cross match to S 303 red blood cells (RBCs) at study entry&#xD;
&#xD;
          6. Must have a blood type of either A+ or O+&#xD;
&#xD;
          7. Patients must have a likelihood of receiving a transfusion as determined by the&#xD;
             Investigator OR a Transfusion Risk Understanding Screening Tool (TRUST) Score of ≥3 at&#xD;
             study entry&#xD;
&#xD;
          8. Must be scheduled to receive one of the following operative procedures:&#xD;
&#xD;
               -  Coronary artery bypass graft only, first procedure&#xD;
&#xD;
               -  Valve repair or replacement only, first procedure&#xD;
&#xD;
               -  A combination of first time Coronary Artery Bypass Graft (CABG) and valve repair&#xD;
                  or replacement&#xD;
&#xD;
        After consultation with the Medical Monitor, provision can be made to enroll patients who&#xD;
        may meet these general criteria but whose surgical procedure is not precisely described in&#xD;
        the above categories. Such patients will be classified as &quot;other&quot; with their explicit&#xD;
        condition reported with other study data.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A positive pregnancy test result&#xD;
&#xD;
          2. Inability of patient to comply with the protocol in the opinion of the Investigator or&#xD;
             attending physician&#xD;
&#xD;
          3. Breast-feeding of an infant or child&#xD;
&#xD;
          4. Active autoimmune hemolytic anemia, or a positive Direct Antiglobulin Test (DAT)&#xD;
             result&#xD;
&#xD;
          5. Treatment with any medication that is known to adversely affect red blood cell&#xD;
             viability&#xD;
&#xD;
          6. Emergent or salvage surgical status at the time of surgery defined as follows:&#xD;
&#xD;
               -  Presence of ongoing ischemia including angina at rest despite maximal medical&#xD;
                  therapy&#xD;
&#xD;
               -  Acute evolving myocardial infarction within 24 hours before surgery&#xD;
&#xD;
               -  Pulmonary edema requiring intubation&#xD;
&#xD;
               -  Presence of shock or hemodynamic instability with or without circulatory support&#xD;
&#xD;
               -  Systolic blood pressure &lt; 80 mm Hg and/or Cardiac Index &lt; 1.8 despite medical&#xD;
                  intervention (intravenous inotropes or similar pharmacologic agents)&#xD;
&#xD;
               -  Cardiopulmonary resuscitation in the 24 hours prior to surgery or anesthesia&#xD;
                  induction&#xD;
&#xD;
               -  Requiring an intra-aortic balloon pump or ventricular assist device&#xD;
&#xD;
          7. Participation in any one of the following types of clinical studies either&#xD;
             concurrently or within the previous 28 days: investigational blood products,&#xD;
             pharmacologic agents or imaging materials, including dyes, investigational surgical&#xD;
             techniques, or devices. Studies of nutrition, psychology, or socioeconomic issues are&#xD;
             not grounds for exclusion&#xD;
&#xD;
          8. Current diagnosis of either chronic or acute renal failure (requiring dialysis) or a&#xD;
             serum creatinine greater than or equal to 1.8 mg/dL within 30 days prior to the start&#xD;
             of surgery&#xD;
&#xD;
          9. Current diagnosis of either chronic or acute hepatic insufficiency or a total serum&#xD;
             bilirubin greater than or equal to 2.0 mg/dL within 30 days prior to the start of&#xD;
             surgery&#xD;
&#xD;
         10. Pre-existing RBC antibody that may make the provision of compatible study red blood&#xD;
             cell (RBC) components difficult&#xD;
&#xD;
         11. Patients requiring plasma removal or irradiation of the RBC&#xD;
&#xD;
         12. Patients with prior history of severe allergic transfusion reactions&#xD;
&#xD;
         13. A positive cross match to S 303 treated RBC&#xD;
&#xD;
             -&#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>Arndt H Kiessling, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinikum der J.-W.-G.-Universität Frankfurt</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Katharina Madlener, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kerckhoff-Klinic GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kerckhoff-Klinic GmbH</name>
      <address>
        <city>Bad Nauheim</city>
        <state>Hessen</state>
        <zip>61231</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der J.-W.-G.-Universität Frankfurt</name>
      <address>
        <city>Frankfurt</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <removed_countries>
    <country>France</country>
  </removed_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 26, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>August 24, 2015</last_update_submitted>
  <last_update_submitted_qc>August 24, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 26, 2015</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>Anemia</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/NCT01716923
org study id: CLI 00070
nct id: NCT01716923
lead sponsor: 
has dmc: No
The clinical study will assess the in-vitro characteristics of red blood cells (RBCs) per the
      European Union (EU) criteria for leukocyte depleted RBCs in additive solution and evaluate
      the safety and efficacy of S-303 treated RBCs in a patient population requiring RBC
      transfusion support for acute anemia.
allocation: Randomized
intervention model: Parallel Assignment
masking: Triple (Participant, Care Provider, Investigator)
measure: Primary Efficacy Endpoint - mean hemoglobin content
time frame: Day 2
description: The mean hemoglobin content per red blood cell (RBC) component compared between the treatment groups
measure: Primary Safety Endpoint - Adverse events
time frame: 90 days
description: The frequency of adverse events (related and unrelated to study RBC components) will be compared between the treatment groups.
measure: Secondary Efficacy Endpoint
time frame: Day 35
description: Proportion of RBC components that have adenosine-5'-triphosphate (ATP) levels of greater than 2 μmol/L
measure: Secondary Efficacy Endpoint
time frame: Day 35
description: Proportion of RBC components that meet the European Union (EU) guideline for hemoglobin content, hematocrit, and hemolysis at the end of storage
measure: Secondary Efficacy Endpoint
time frame: Day 35
description: Proportion of RBC components that have plasma-free hemoglobin levels corresponding to ≤ 0.8% hemolysis
measure: Exploratory Endpoint - incidence of renal insufficiency
time frame: Daily on days 0 through 6
description: Incidence of renal insufficiency, indicated by serum creatinine level >2 mg/dL WITH at least a 50% increase from pre-operative baseline OR a new requirement for therapy to treat renal insufficiency (dialysis)
measure: Exploratory Endpoint - incidence of hepatic insufficiency
time frame: Daily on days 0 through 6
description: Incidence of hepatic insufficiency, indicated by total bilirubin that is >2 times the upper limit of normal AND represents at least a 50% increase from the preoperative baseline
measure: Exploratory endpoint - Cardiopulmonary function
time frame: Day 7 and 13
description: Cardiopulmonary function at the time of first ambulation and at the time of discharge, as measured by a standardized 6 Minute Walk Test (6MWT)
arm group label: S-303 Treated Red Blood Cells
arm group type: Experimental
description: Patients receive S-303 treated red blood cells (RBCs).
arm group label: Conventional, untreated Red Blood Cells
arm group type: Active Comparator
description: Patients receive conventional, untreated red blood cells (RBCs).
intervention type: Biological
intervention name: S-303 Red Blood Cells (RBCs) - Test
arm group label: S-303 Treated Red Blood Cells
intervention type: Biological
intervention name: Conventional, untreated red blood cells (RBCs) - Control
arm group label: Conventional, untreated Red Blood Cells
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Arndt H Kiessling, MD
role: Principal Investigator
affiliation: Klinikum der J.-W.-G.-Universität Frankfurt
last name: Katharina Madlener, Dr
role: Principal Investigator
affiliation: Kerckhoff-Klinic GmbH
facility: 
facility: 
country: Germany
country: France
responsible party type: Sponsor
mesh term: Anemia