<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/NCT03284944</url>
  </required_header>
  <id_info>
    <org_study_id>STRATUS Pilot</org_study_id>
    <nct_id>NCT03284944</nct_id>
  </id_info>
  <brief_title>Small-Volume Tubes to Reduce Anemia and Transfusion (STRATUS)</brief_title>
  <official_title>Small-Volume Tubes to Reduce Anemia and Transfusion (STRATUS): A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Population Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Population Health Research Institute</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>
      STRATUS will evaluate the use of small-volume (&quot;soft-draw&quot;) blood collection tubes for&#xD;
      laboratory testing in reducing anemia and transfusion in intensive care unit patients without&#xD;
      significant adverse consequences. This is a simple, cost-neutral intervention that could&#xD;
      improve the quality of patient care and reduce the harms of frequent laboratory testing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The STRATUS Pilot Study is a prospective observational study (before-after design) to assess&#xD;
      the feasibility of implementing a full-scale randomized trial powered for clinical outcomes&#xD;
      (RBC transfusion, incidence and severity of anemia). Identification of barriers and&#xD;
      facilitators of implementation will enhance the conduct of the full-scale trial and&#xD;
      facilitate incorporation of the intervention into routine practice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">February 7, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Successful crossover from standard-volume to small-volume tubes</measure>
    <time_frame>2 week washout period</time_frame>
    <description>Defined as at least 95% correct tubes collected during an audit of tubes in the storage area at the end of the washout period</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adherence to the correct tube size during the intervention period</measure>
    <time_frame>6 week intervention period</time_frame>
    <description>Defined as at least 95% adherence to allocated tube size evaluated during audits of tubes in the storage area</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sufficient volume for testing with small-volume tubes</measure>
    <time_frame>6 week intervention period</time_frame>
    <description>Defined as &lt;3% of samples reported as inadequate volume for testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of the intervention by end-users</measure>
    <time_frame>6 week intervention period</time_frame>
    <description>Acceptability qualitatively evaluated during structured focus group discussions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complete primary data collection</measure>
    <time_frame>14 weeks</time_frame>
    <description>Defined as at least 95% of patients with complete data collected</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reduction in blood loss</measure>
    <time_frame>12 weeks</time_frame>
    <description>Reduction in blood loss from routine hematology, chemistry, and coagulation testing using small-volume tubes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RBC units transfused</measure>
    <time_frame>12 weeks</time_frame>
    <description>Number of RBC units transfused per patient-day in the ICU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in hemoglobin</measure>
    <time_frame>12 weeks</time_frame>
    <description>Change in hemoglobin level from ICU admission to ICU discharge (or death) adjusted for RBC transfusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU and hospital length of stay</measure>
    <time_frame>12 weeks</time_frame>
    <description>ICU and hospital length of stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU and hospital mortality</measure>
    <time_frame>12 weeks</time_frame>
    <description>ICU and in-hospital mortality</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">369</enrollment>
  <condition>Blood Loss Anemia</condition>
  <arm_group>
    <arm_group_label>Control (Before) Period</arm_group_label>
    <description>Use of standard-volume blood collection tubes (6 weeks)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention (After) Period</arm_group_label>
    <description>Use of small-volume (&quot;soft-draw&quot;) blood collection tubes (6 weeks following 2-week washout period)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Small-Volume</intervention_name>
    <description>Small-volume (2 - 3 mL &quot;soft-draw&quot; Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.</description>
    <arm_group_label>Intervention (After) Period</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard-Volume</intervention_name>
    <description>Standard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.</description>
    <arm_group_label>Control (Before) Period</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult patients admitted to the participating intensive care unit at the investigative&#xD;
        site.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Investigative Site Eligibility:&#xD;
&#xD;
          -  Intensive care unit with at least 15 beds with capacity for mechanical ventilation&#xD;
&#xD;
          -  Current standard to use standard-draw blood collection tubes&#xD;
&#xD;
          -  Availability of hospital administrative data and electronic patient information&#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>Deborah Siegal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Population Health Research Institute, McMaster University, Hamilton Health Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stuart Connolly, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Population Health Research Institute, McMaster University, Hamilton Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hamilton Health Sciences - Hamilton General Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>July 9, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>September 16, 2020</last_update_submitted>
  <last_update_submitted_qc>September 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2020</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>
  <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/NCT03284944
org study id: STRATUS Pilot
nct id: NCT03284944
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
STRATUS will evaluate the use of small-volume ("soft-draw") blood collection tubes for
      laboratory testing in reducing anemia and transfusion in intensive care unit patients without
      significant adverse consequences. This is a simple, cost-neutral intervention that could
      improve the quality of patient care and reduce the harms of frequent laboratory testing.
The STRATUS Pilot Study is a prospective observational study (before-after design) to assess
      the feasibility of implementing a full-scale randomized trial powered for clinical outcomes
      (RBC transfusion, incidence and severity of anemia). Identification of barriers and
      facilitators of implementation will enhance the conduct of the full-scale trial and
      facilitate incorporation of the intervention into routine practice.
observational model: Cohort
time perspective: Prospective
measure: Successful crossover from standard-volume to small-volume tubes
time frame: 2 week washout period
description: Defined as at least 95% correct tubes collected during an audit of tubes in the storage area at the end of the washout period
measure: Adherence to the correct tube size during the intervention period
time frame: 6 week intervention period
description: Defined as at least 95% adherence to allocated tube size evaluated during audits of tubes in the storage area
measure: Sufficient volume for testing with small-volume tubes
time frame: 6 week intervention period
description: Defined as <3% of samples reported as inadequate volume for testing
measure: Acceptability of the intervention by end-users
time frame: 6 week intervention period
description: Acceptability qualitatively evaluated during structured focus group discussions
measure: Complete primary data collection
time frame: 14 weeks
description: Defined as at least 95% of patients with complete data collected
measure: Reduction in blood loss
time frame: 12 weeks
description: Reduction in blood loss from routine hematology, chemistry, and coagulation testing using small-volume tubes.
measure: RBC units transfused
time frame: 12 weeks
description: Number of RBC units transfused per patient-day in the ICU.
measure: Change in hemoglobin
time frame: 12 weeks
description: Change in hemoglobin level from ICU admission to ICU discharge (or death) adjusted for RBC transfusion.
measure: ICU and hospital length of stay
time frame: 12 weeks
description: ICU and hospital length of stay
measure: ICU and hospital mortality
time frame: 12 weeks
description: ICU and in-hospital mortality
arm group label: Control (Before) Period
description: Use of standard-volume blood collection tubes (6 weeks)
arm group label: Intervention (After) Period
description: Use of small-volume ("soft-draw") blood collection tubes (6 weeks following 2-week washout period)
intervention type: Device
intervention name: Small-Volume
description: Small-volume (2 - 3 mL "soft-draw" Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.
arm group label: Intervention (After) Period
intervention type: Device
intervention name: Standard-Volume
description: Standard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.
arm group label: Control (Before) Period
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Deborah Siegal, MD
role: Principal Investigator
affiliation: Population Health Research Institute, McMaster University, Hamilton Health Sciences
last name: Stuart Connolly, MD
role: Principal Investigator
affiliation: Population Health Research Institute, McMaster University, Hamilton Health Sciences
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Anemia
sharing ipd: No