Autologous Blood TransfusionNCT04496700
Transfusion of Whole Blood to Military Forces in a Combat Situation
A study testing Whole blood donation and transfusion in people with Autologous Blood Transfusion and Physical Performance, run by Haukeland University Hospital at 2 sites in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Autologous Blood Transfusion, Physical Performance, Donor Safety
- What is being tested?
- Whole blood donation and transfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesNorway
- Study dates
- Sep 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Military personel deployable to combat situations
Who cannot join
- General health issues
Trial locations and contacts
2 sites in 1 country.
Norway2 sites
Haukeland University Hospital
Bergen, 5021
Norwegian Naval Base Haakonsvern
Bergen, 5886
About this study
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:
Read more
- A soldier donates blood to a wounded fellow soldier
- 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:
- Can 'buddy transfusion' in the field be justified also in medical aspects?
- 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
Read the detailed description
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.
- Being tested
- Whole blood donation and transfusion
- Keywords
- Autologous Blood Transfusion, Whole Blood Storage Conditions, Physical Performance, Donor Safety, Combat Field
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole blood donation and transfusionProcedure or surgery
The effect of whole blood donation on physical performance:
Donation of 450 ml whole blood - one time only.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Shooting test | Experimental | All participants in this group were tested for shooting abilities before and after blood donation. No variation within the group. Receives: Procedure: Whole blood donation and transfusion |
| Group 2 - VO2max | Experimental | 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. Receives: Procedure: Whole blood donation and transfusion |
| Group 3 - Feasability | Experimental | 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. Receives: Procedure: Whole blood donation and transfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of hits
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.
Measured: Pre- and postdonation
Secondary outcomes (2)
Maximum heart rate (n/min)
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.
Measured: Pre- and postdonation
Minutes spent walking up and down the mountain Ulriken
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.
Measured: Pre- and postdonation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study startSep 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous Blood TransfusionStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geir Strandenes, OF3, Principal investigator, Haukeland UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496700
- Sponsor's protocol ID
- 2010/1559
- Status last verified
- Jul 2013
- First submitted
- 7 Jul 2013
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion of Whole Blood to Military Forces in a Combat Situation
- ClinicalTrials.gov ID
- NCT04496700
- Acronym / sponsor ID
- 2010/1559
- Keywords
- Autologous Blood Transfusion, Whole Blood Storage Conditions, Physical Performance, Donor Safety, Combat Field
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- A soldier donates blood to a wounded fellow soldier
- 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:
- Can 'buddy transfusion' in the field be justified also in medical aspects?
- 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
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Shooting test | Experimental | Procedure: Whole blood donation and transfusionAll participants in this group were tested for shooting abilities before and after blood donation. No variation within the group. |
| Group 2 - VO2max | Experimental | Procedure: Whole blood donation and transfusionAll participants in this group were tested for physical abilities before and after blood donation. Method: Bruce protocol. No variation of protocol within the group. |
| Group 3 - Feasability | Experimental | Procedure: Whole blood donation and transfusionAll 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Military personel deployable to combat situations
Key exclusion criteria (1 listed)
- General health issues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole blood donation and transfusionThe effect of whole blood donation on physical performance: Donation of 450 ml whole blood - one time only. | Procedure or surgery | Group 1 - Shooting test, Group 2 - VO2max, Group 3 - Feasability |
Primary outcome
Number of hits
Time frame: Pre- and postdonation
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.
2 secondary outcomes
Maximum heart rate (n/min)
Time frame: Pre- and postdonation
Minutes spent walking up and down the mountain Ulriken
Time frame: Pre- and postdonation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geir Strandenes, OF3 principal investigator
Haukeland UH
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole blood donation and transfusion in people with Autologous Blood Transfusion and Physical Performance, run by Haukeland University Hospital at 2 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of hits (time frame: Pre- and postdonation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.