<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/NCT04496700</url>
  </required_header>
  <id_info>
    <org_study_id>2010/1559</org_study_id>
    <nct_id>NCT04496700</nct_id>
  </id_info>
  <brief_title>Transfusion of Whole Blood to Military Forces in a Combat Situation</brief_title>
  <official_title>Transfusion of Whole Blood to Military Forces in a Combat Situation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haukeland University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Haukeland University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      During military action there might be situations where civil requirements for blood&#xD;
      transfusion are not obtainable. Numerous warfare experiences suggest that administration of&#xD;
      whole blood to a patient with uncontrollable bleeding/bleeding shock will improve survival in&#xD;
      case of delayed evacuation.&#xD;
&#xD;
      Among Norwegian troops this gives one of two choices:&#xD;
&#xD;
        1. A soldier donates blood to a wounded fellow soldier&#xD;
&#xD;
        2. Personnel in safe distance donates blood and it is transported to the frontline.&#xD;
&#xD;
      Alternative b might implicate frequent donations and unused blood must be auto-re-transfused.&#xD;
&#xD;
      This study will investigate:&#xD;
&#xD;
        1. Can 'buddy transfusion' in the field be justified also in medical aspects?&#xD;
&#xD;
        2. Can repeated donations and auto-transfusions of transported whole blood into&#xD;
           personnel(X) be justified also in medical aspects?&#xD;
&#xD;
      (X) Blood typed and screened for HIV, HBV, HCV, Syphilis before assignment&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MATERIALS AND METHODS&#xD;
&#xD;
      The study was approved by the research ethics committee of the Regional West Health Trust,&#xD;
      Norway. Twenty-five nonsmoking male soldiers, median age 29 years, from a Navy special forces&#xD;
      unit consented to participate. Mean body mass index was 24.7 kg/m2 (range, 22.6-28.3 kg/m2).&#xD;
&#xD;
      This is a pilot study and we were not able to find data in the literature providing&#xD;
      information for power calculations regarding the testing we included in the study. The&#xD;
      participants were divided in three different groups for testing. The grouping was based on&#xD;
      availability at the given time points, and there was no selection to any specific group:&#xD;
      Group 1-Bruce protocol treadmill stress test, push-ups, and pull-ups (n = 7); Group&#xD;
      2-50-round pistol shooting test (n = 12); and Group 3-uphill hiking exercise carrying a 20-kg&#xD;
      backpack (n = 6). Each group was tested twice, before and immediately after donation of 450&#xD;
      mL of blood.&#xD;
&#xD;
      The soldiers were allowed to rehydrate during the donation procedure and theywere all offered&#xD;
      a 0.5-L water bottle. The exact volume each participant consumed was not recorded. All 25&#xD;
      soldiers participated in a 60-minute training program aimed at testing whether it is possible&#xD;
      to teach nonmedic soldiers buddy transfusion during a short period.&#xD;
&#xD;
      Multistage treadmill stress test, push-ups, and pull-ups&#xD;
&#xD;
      VO2 max was estimated in seven soldiers. Bruce protocol was followed, using a multistaged&#xD;
      treadmill test. Each stage lasted for 3 minutes, and in total seven stages were included in&#xD;
      the procedure. For each stage, belt velocity and slope were increased (see Table 1). The&#xD;
      soldiers ran until exhaustion (unable to continue running). Heart rate and lactate were&#xD;
      measured at the end of each stage and at exhaustion when total time on belt (T) was noted.&#xD;
      Lactate was measured in a blood sample from the ear lobule and a portable lactate analyzer&#xD;
      (Lactate Scout, EKF Diagnostics, Barleben, Germany) was used. From the total run time used,&#xD;
      VO2 max was estimated as follows:14 VO2 max = 14.8-(1.379 ¥ T) + (0.451 ¥ T2) - (0.012 ¥ T3).&#xD;
      The pushups were performed as &quot;full push-up&quot; in the prone position, with the back and legs&#xD;
      straight and off the floor. The hands were placed below each shoulder, with arms fully&#xD;
      extended. From this start position, the body was lowered by using the arms until the chest&#xD;
      touched the floor, and then back to the start position. Standard pull-ups were performed as a&#xD;
      dead-hang pull-up, with an overhand grip. Then the body was pulled up until the chin cleared&#xD;
      the bar, and finished by lowering the body until arms and shoulders were fully extended A&#xD;
      baseline test (predonation test) was performed 4 days prior to donation, and the postdonation&#xD;
      test immediately after donating blood. The soldiers performed the procedures until they were&#xD;
      unable to continue. The test endpoint was differences in estimated VO2 max, maximum heart&#xD;
      rate (HRmax), lactate, and number of push-ups and pull-ups.&#xD;
&#xD;
      Fifty-round pistol shooting test&#xD;
&#xD;
      Twelve soldiers performed a standard Navy special operational forces protocol rapid shooting&#xD;
      test, using their personalweapon (9 mm).The protocol has five separate tests, each with 10&#xD;
      rounds (6 mnondominant hand, 10 mdominant hand, 10 m 2 + 1, 18 m precision, 25 m precision).&#xD;
      The predonation test was performed 2 days before donation, and the postdonation test&#xD;
      immediately after donating blood. The weather and light conditions were similar on the test&#xD;
      days. The study outcome in this exercise was differences in total hits.&#xD;
&#xD;
      Uphill hiking exercise&#xD;
&#xD;
      Six soldiers were tested on an uphill exercise carrying a 20-kg backpack. The track had a 28%&#xD;
      slope and 450-m altitude difference; the soldiers were instructed to walk as a group, and no&#xD;
      individual time measurements could therefore be recorded. The soldiers walked up and down&#xD;
      again as quickly as they were able to (no running) before they donated 1 unit of blood. They&#xD;
      thenwere offered water (ad libitum) to rehydrate without any further break before they&#xD;
      repeated the exercise, again walking as quickly as the group managed. The endpoint was the&#xD;
      difference in time used by the team on the uphill part of the track. The soldiers also filled&#xD;
      in a questionnaire to report possible side effects related to the donation and the&#xD;
      postdonation performance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">June 2011</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>The participants will take part in one of three tasks, and will be tested in their respective task twice: both before and after blood donation (the intervention).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of hits</measure>
    <time_frame>Pre- and postdonation</time_frame>
    <description>The effect of whole blood donation on Combat Readiness Skills is evaluated by various tasks, among them a 50-round pistol shooting test (Standard Navy SOF protocol). The shooting test was performed before and immediately after donation of 450 ml whole blood.&#xD;
This outcome measure depicts number of hits in total, pre- and postdonation, respectively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum heart rate (n/min)</measure>
    <time_frame>Pre- and postdonation</time_frame>
    <description>The effect of whole blood donation on Combat Readiness Skills is evaluated by various tasks, among them a so-called Bruce protocol. This protocol was performed before and immediately after donation of 450 ml whole blood.&#xD;
This outcome measure depicts maximum heart rate (n per minute), pre- and postdonation, respectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minutes spent walking up and down the mountain Ulriken</measure>
    <time_frame>Pre- and postdonation</time_frame>
    <description>The effect of whole blood donation on Combat Readiness Skills is evaluated by various tasks, among them hiking up and down a mountain with a 28 % slope, 450 meters altitude difference and a 20 kg backpack.&#xD;
The endurance test was performed before and immediately after donation of 450 ml whole blood.&#xD;
This outcome measure depicts time in minutes, spent walking up and down the moutain, pre- and postdonation, respectively.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Autologous Blood Transfusion</condition>
  <condition>Physical Performance</condition>
  <condition>Donor Safety</condition>
  <arm_group>
    <arm_group_label>Group 1 - Shooting test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants in this group were tested for shooting abilities before and after blood donation. No variation within the group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 - VO2max</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants in this group were tested for physical abilities before and after blood donation. Method: Bruce protocol.&#xD;
No variation of protocol within the group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3 - Feasability</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants in this group were tested for feasability before and after blood donation. Method: Hiking uphill with 20 kg backpack.&#xD;
No variation of method within the group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Whole blood donation and transfusion</intervention_name>
    <description>The effect of whole blood donation on physical performance:&#xD;
Donation of 450 ml whole blood - one time only.</description>
    <arm_group_label>Group 1 - Shooting test</arm_group_label>
    <arm_group_label>Group 2 - VO2max</arm_group_label>
    <arm_group_label>Group 3 - Feasability</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Military personel deployable to combat situations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  General health issues&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Geir Strandenes, OF3</last_name>
    <role>Principal Investigator</role>
    <affiliation>Haukeland UH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Haukeland University Hospital</name>
      <address>
        <city>Bergen</city>
        <zip>5021</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norwegian Naval Base Haakonsvern</name>
      <address>
        <city>Bergen</city>
        <zip>5886</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>July 7, 2013</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Autologous Blood Transfusion</keyword>
  <keyword>Whole Blood Storage Conditions</keyword>
  <keyword>Physical Performance</keyword>
  <keyword>Donor Safety</keyword>
  <keyword>Combat Field</keyword>
  <!-- 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/NCT04496700
org study id: 2010/1559
nct id: NCT04496700
lead sponsor: 
has dmc: No
During military action there might be situations where civil requirements for blood
      transfusion are not obtainable. Numerous warfare experiences suggest that administration of
      whole blood to a patient with uncontrollable bleeding/bleeding shock will improve survival in
      case of delayed evacuation.

      Among Norwegian troops this gives one of two choices:

        1. A soldier donates blood to a wounded fellow soldier

        2. Personnel in safe distance donates blood and it is transported to the frontline.

      Alternative b might implicate frequent donations and unused blood must be auto-re-transfused.

      This study will investigate:

        1. Can 'buddy transfusion' in the field be justified also in medical aspects?

        2. Can repeated donations and auto-transfusions of transported whole blood into
           personnel(X) be justified also in medical aspects?

      (X) Blood typed and screened for HIV, HBV, HCV, Syphilis before assignment
MATERIALS AND METHODS

      The study was approved by the research ethics committee of the Regional West Health Trust,
      Norway. Twenty-five nonsmoking male soldiers, median age 29 years, from a Navy special forces
      unit consented to participate. Mean body mass index was 24.7 kg/m2 (range, 22.6-28.3 kg/m2).

      This is a pilot study and we were not able to find data in the literature providing
      information for power calculations regarding the testing we included in the study. The
      participants were divided in three different groups for testing. The grouping was based on
      availability at the given time points, and there was no selection to any specific group:
      Group 1-Bruce protocol treadmill stress test, push-ups, and pull-ups (n = 7); Group
      2-50-round pistol shooting test (n = 12); and Group 3-uphill hiking exercise carrying a 20-kg
      backpack (n = 6). Each group was tested twice, before and immediately after donation of 450
      mL of blood.

      The soldiers were allowed to rehydrate during the donation procedure and theywere all offered
      a 0.5-L water bottle. The exact volume each participant consumed was not recorded. All 25
      soldiers participated in a 60-minute training program aimed at testing whether it is possible
      to teach nonmedic soldiers buddy transfusion during a short period.

      Multistage treadmill stress test, push-ups, and pull-ups

      VO2 max was estimated in seven soldiers. Bruce protocol was followed, using a multistaged
      treadmill test. Each stage lasted for 3 minutes, and in total seven stages were included in
      the procedure. For each stage, belt velocity and slope were increased (see Table 1). The
      soldiers ran until exhaustion (unable to continue running). Heart rate and lactate were
      measured at the end of each stage and at exhaustion when total time on belt (T) was noted.
      Lactate was measured in a blood sample from the ear lobule and a portable lactate analyzer
      (Lactate Scout, EKF Diagnostics, Barleben, Germany) was used. From the total run time used,
      VO2 max was estimated as follows:14 VO2 max = 14.8-(1.379 ¥ T) + (0.451 ¥ T2) - (0.012 ¥ T3).
      The pushups were performed as "full push-up" in the prone position, with the back and legs
      straight and off the floor. The hands were placed below each shoulder, with arms fully
      extended. From this start position, the body was lowered by using the arms until the chest
      touched the floor, and then back to the start position. Standard pull-ups were performed as a
      dead-hang pull-up, with an overhand grip. Then the body was pulled up until the chin cleared
      the bar, and finished by lowering the body until arms and shoulders were fully extended A
      baseline test (predonation test) was performed 4 days prior to donation, and the postdonation
      test immediately after donating blood. The soldiers performed the procedures until they were
      unable to continue. The test endpoint was differences in estimated VO2 max, maximum heart
      rate (HRmax), lactate, and number of push-ups and pull-ups.

      Fifty-round pistol shooting test

      Twelve soldiers performed a standard Navy special operational forces protocol rapid shooting
      test, using their personalweapon (9 mm).The protocol has five separate tests, each with 10
      rounds (6 mnondominant hand, 10 mdominant hand, 10 m 2 + 1, 18 m precision, 25 m precision).
      The predonation test was performed 2 days before donation, and the postdonation test
      immediately after donating blood. The weather and light conditions were similar on the test
      days. The study outcome in this exercise was differences in total hits.

      Uphill hiking exercise

      Six soldiers were tested on an uphill exercise carrying a 20-kg backpack. The track had a 28%
      slope and 450-m altitude difference; the soldiers were instructed to walk as a group, and no
      individual time measurements could therefore be recorded. The soldiers walked up and down
      again as quickly as they were able to (no running) before they donated 1 unit of blood. They
      thenwere offered water (ad libitum) to rehydrate without any further break before they
      repeated the exercise, again walking as quickly as the group managed. The endpoint was the
      difference in time used by the team on the uphill part of the track. The soldiers also filled
      in a questionnaire to report possible side effects related to the donation and the
      postdonation performance.
allocation: Non-Randomized
intervention model: Single Group Assignment
intervention model description: The participants will take part in one of three tasks, and will be tested in their respective task twice: both before and after blood donation (the intervention).
primary purpose: Other
masking: None (Open Label)
measure: Number of hits
time frame: Pre- and postdonation
description: The effect of whole blood donation on Combat Readiness Skills is evaluated by various tasks, among them a 50-round pistol shooting test (Standard Navy SOF protocol). The shooting test was performed before and immediately after donation of 450 ml whole blood.
This outcome measure depicts number of hits in total, pre- and postdonation, respectively.
measure: Maximum heart rate (n/min)
time frame: Pre- and postdonation
description: The effect of whole blood donation on Combat Readiness Skills is evaluated by various tasks, among them a so-called Bruce protocol. This protocol was performed before and immediately after donation of 450 ml whole blood.
This outcome measure depicts maximum heart rate (n per minute), pre- and postdonation, respectively.
measure: Minutes spent walking up and down the mountain Ulriken
time frame: Pre- and postdonation
description: The effect of whole blood donation on Combat Readiness Skills is evaluated by various tasks, among them hiking up and down a mountain with a 28 % slope, 450 meters altitude difference and a 20 kg backpack.
The endurance test was performed before and immediately after donation of 450 ml whole blood.
This outcome measure depicts time in minutes, spent walking up and down the moutain, pre- and postdonation, respectively.
arm group label: Group 1 - Shooting test
arm group type: Experimental
description: All participants in this group were tested for shooting abilities before and after blood donation. No variation within the group.
arm group label: Group 2 - VO2max
arm group type: Experimental
description: All participants in this group were tested for physical abilities before and after blood donation. Method: Bruce protocol.
No variation of protocol within the group.
arm group label: Group 3 - Feasability
arm group type: Experimental
description: All participants in this group were tested for feasability before and after blood donation. Method: Hiking uphill with 20 kg backpack.
No variation of method within the group.
intervention type: Procedure
intervention name: Whole blood donation and transfusion
description: The effect of whole blood donation on physical performance:
Donation of 450 ml whole blood - one time only.
arm group label: Group 1 - Shooting test
arm group label: Group 2 - VO2max
arm group label: Group 3 - Feasability
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Geir Strandenes, OF3
role: Principal Investigator
affiliation: Haukeland UH
facility: 
facility: 
country: Norway
responsible party type: Sponsor