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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Norway1 site
  • Haukeland University Hospital

    Bergen, 5021

Other trials in Norway

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.

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 groups in NCT02924792
Study groupRoleWhat they receive
Reinfusion - Fast1Case: Autologous reinfusion through Fast1 sternal needle. (Pyng Medical) CE marked/FDA Approved
Receives: Device: Reinfusion - Sternal IO needle
Reinfusion - T.A.L.O.NCase: Autologous reinfusion through T.A.L.O.N sternal needle. (Vidacare) CE Marked/FDA approved
Receives: Device: Reinfusion - Sternal IO needle
Reinfusion - Intravenous lineControl: 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.

  1. Flowrate of reinfusion of whole blood

    The total time of reinfusion of 450cc Whole blood

    Measured: 45 minutes

  2. Post transfusion hemolysis

    Hemolysis as measured by Haptoglobin and LD measures

    Measured: 3 hours

Secondary outcomes (1)
  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.

  1. First posted5 Oct 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionOct 2017
  4. Study completion5 Dec 2017

Resources

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)
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.

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.

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