Hypovolemic ShockNCT02924792
Sternal Intraosseous Transfusion of Autologous Whole Blood: A Comparison of Flow Rates and Degree of Hemolysis
An observational study of Hypovolemic Shock and Hemorrhagic Shock, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
In this study the impact of two CE marked and FDA approved sternal needles in comparison to intravenous access on the flow-rate of autologous reinfusion of whole blood and the possible hemolysis of red cells post-transfusion in a population of healthy military officers is investigated. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hypovolemic Shock, Hemorrhagic Shock
- What is being tested?
- Reinfusion - Sternal IO needle and Reinfusion - Intravenous needle
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 30 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2016to 5 Dec 2017
- Phase
- Observational
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Healthy military officers
Who may be able to join
- Male, Professional special forces military officers
- Medically cleared for for military exercise or Activity
- Signed standardized informed consent
Who cannot join
- Participants who will not provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
In this study the impact of two CE marked and FDA approved sternal needles in comparison to intravenous access on the flow-rate of autologous reinfusion of whole blood and the possible hemolysis of red cells post-transfusion in a population of healthy military officers is investigated.
Read the detailed description
Intraosseous (IO) access is an old technique for achieving entrance to the systemic circulation, which has gained resurgence in the last 30 years.
Whether due to trauma or disease, vascular collapse may delay or preclude even experienced medical providers from obtaining standard intravenous (IV) access. Access to the vascular system of the critically ill or injured adult or pediatric patient is essential for resuscitation, and flow rates close up to what can be obtained by using intravenous access is preferable in patient needing immediate fluid boluses for shock resuscitation. Intraosseous access takes advantage of the vascularity of cancellous bone, the spongy bone inside the hard, and access to the highly vascular intramedullary space of bones provides a direct link to central circulation. In addition to using long bones, the sternum is used for intraosseous access and has gained increased use especially in combat casualty care.
However, in a recent publication, the intraosseous route used for transfusion of blood components is questioned. Based on theoretical models for flow rates through porous media and personal clinical observations the authors conclude that the maximum flow rates attainable for transfusion of blood via intraosseous route are inadequate for successful resuscitation. They also fear that additional pressure needed to obtain adequate flow rate may cause hemolysis of red blood cells. Further they postulate that as the bone mineral density reaches a peak occurring in the early 20s, and that a small increase in bone density may cause exponential decrease in intrinsic permeability, there could be a 10-fold decrease in permeability in military age causalities compared to the elderly. The critical points highlighted in this review are in great contrast to recent experience with the use of sternal and humeral I.O's in Operation Enduring Freedom (OEF).
This observational study investigates the impact of two CE marked and FDA approved sternal needles in comparison to intravenous access on the flow-rate of autologous reinfusion of whole blood and the possible hemolysis of red cells post-transfusion in a population of healthy military officers. We also investigate the technical success rate of sternal IO Access between two CE marked and FDA approved sternal Devices. As a supplementary investigation we seek to investigate the anatomic changes as shown by Magnetic Resonance Imaging in individuals who have received multiple intraosseous sternal needles With autologous reinfusion of whole blood.
- Conditions
- Hypovolemic Shock, Hemorrhagic Shock
- Being tested
- Reinfusion - Sternal IO needle, Reinfusion - Intravenous needle
- Keywords
- Intraosseous access
- Medical subject headings
- Shock, Shock, Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reinfusion - Sternal IO needleDevice
Reinfusion - Intravenous needleDevice
| Study group | Role | What they receive |
|---|---|---|
| Reinfusion - Fast1 | Case: Autologous reinfusion through Fast1 sternal needle. (Pyng Medical) CE marked/FDA Approved Receives: Device: Reinfusion - Sternal IO needle | |
| Reinfusion - T.A.L.O.N | Case: Autologous reinfusion through T.A.L.O.N sternal needle. (Vidacare) CE Marked/FDA approved Receives: Device: Reinfusion - Sternal IO needle | |
| Reinfusion - Intravenous line | Control: Autologous reinfusion through standard intravenous line Receives: Device: Reinfusion - Intravenous needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flowrate of reinfusion of whole blood
The total time of reinfusion of 450cc Whole blood
Measured: 45 minutes
Post transfusion hemolysis
Hemolysis as measured by Haptoglobin and LD measures
Measured: 3 hours
Secondary outcomes (1)
Success rate of sternal IO access
The success rate of a valid IO Access, evaluated by expret
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2017
- Study completion5 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypovolemic ShockStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Defence, Norway
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924792
- Sponsor's protocol ID
- 2014/691
- Status last verified
- Oct 2017
- First submitted
- 4 Oct 2016
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sternal Intraosseous Transfusion of Autologous Whole Blood: A Comparison of Flow Rates and Degree of Hemolysis
- ClinicalTrials.gov ID
- NCT02924792
- Acronym / sponsor ID
- 2014/691
- Conditions
- Hypovolemic Shock, Hemorrhagic Shock
- Keywords
- Intraosseous access
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Defence, Norway
- Study start
- Nov 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- 5 Dec 2017 (actual)
- First posted
- 5 Oct 2016 (estimated)
- 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.
In this study the impact of two CE marked and FDA approved sternal needles in comparison to intravenous access on the flow-rate of autologous reinfusion of whole blood and the possible hemolysis of red cells post-transfusion in a population of healthy military officers is investigated.
Detailed description
Intraosseous (IO) access is an old technique for achieving entrance to the systemic circulation, which has gained resurgence in the last 30 years.
Whether due to trauma or disease, vascular collapse may delay or preclude even experienced medical providers from obtaining standard intravenous (IV) access. Access to the vascular system of the critically ill or injured adult or pediatric patient is essential for resuscitation, and flow rates close up to what can be obtained by using intravenous access is preferable in patient needing immediate fluid boluses for shock resuscitation. Intraosseous access takes advantage of the vascularity of cancellous bone, the spongy bone inside the hard, and access to the highly vascular intramedullary space of bones provides a direct link to central circulation. In addition to using long bones, the sternum is used for intraosseous access and has gained increased use especially in combat casualty care.
However, in a recent publication, the intraosseous route used for transfusion of blood components is questioned. Based on theoretical models for flow rates through porous media and personal clinical observations the authors conclude that the maximum flow rates attainable for transfusion of blood via intraosseous route are inadequate for successful resuscitation. They also fear that additional pressure needed to obtain adequate flow rate may cause hemolysis of red blood cells. Further they postulate that as the bone mineral density reaches a peak occurring in the early 20s, and that a small increase in bone density may cause exponential decrease in intrinsic permeability, there could be a 10-fold decrease in permeability in military age causalities compared to the elderly. The critical points highlighted in this review are in great contrast to recent experience with the use of sternal and humeral I.O's in Operation Enduring Freedom (OEF).
This observational study investigates the impact of two CE marked and FDA approved sternal needles in comparison to intravenous access on the flow-rate of autologous reinfusion of whole blood and the possible hemolysis of red cells post-transfusion in a population of healthy military officers. We also investigate the technical success rate of sternal IO Access between two CE marked and FDA approved sternal Devices. As a supplementary investigation we seek to investigate the anatomic changes as shown by Magnetic Resonance Imaging in individuals who have received multiple intraosseous sternal needles With autologous reinfusion of whole blood.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reinfusion - Fast1 | – | Device: Reinfusion - Sternal IO needleCase: Autologous reinfusion through Fast1 sternal needle. (Pyng Medical) CE marked/FDA Approved |
| Reinfusion - T.A.L.O.N | – | Device: Reinfusion - Sternal IO needleCase: Autologous reinfusion through T.A.L.O.N sternal needle. (Vidacare) CE Marked/FDA approved |
| Reinfusion - Intravenous line | – | Device: Reinfusion - Intravenous needleControl: Autologous reinfusion through standard intravenous line |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy military officers
Key inclusion criteria (3 listed)
- Male, Professional special forces military officers
- Medically cleared for for military exercise or Activity
- Signed standardized informed consent
Key exclusion criteria (1 listed)
- Participants who will not provide informed consent
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 |
|---|---|---|
| Reinfusion - Sternal IO needle | Device | Reinfusion - Fast1, Reinfusion - T.A.L.O.N |
| Reinfusion - Intravenous needle | Device | Reinfusion - Intravenous line |
Primary outcome
Flowrate of reinfusion of whole blood
Time frame: 45 minutes
The total time of reinfusion of 450cc Whole blood
Post transfusion hemolysis
Time frame: 3 hours
Hemolysis as measured by Haptoglobin and LD measures
1 secondary outcome
Success rate of sternal IO access
Time frame: 30 minutes
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 8 Dec 2017.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available within 6 months of study completion.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypovolemic Shock and Hemorrhagic Shock, run by Haukeland University Hospital at 1 site 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 3 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 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Flowrate of reinfusion of whole blood (time frame: 45 minutes). The study lists 2 primary outcomes in all. 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 8 Dec 2017.