Sternal Intraosseous Transfusion of Autologous Whole Blood: A Comparison of Flow Rates and Degree of Hemolysis
NCT ID: NCT02924792
Last Updated: 2017-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2016-11-30
2017-12-05
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Reinfusion - Fast1
Case: Autologous reinfusion through Fast1 sternal needle. (Pyng Medical) CE marked/FDA Approved
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
Reinfusion - Sternal IO needle
Reinfusion - Intravenous line
Control: Autologous reinfusion through standard intravenous line
Reinfusion - Intravenous needle
Interventions
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Reinfusion - Sternal IO needle
Reinfusion - Intravenous needle
Eligibility Criteria
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Inclusion Criteria
* Medically cleared for for military exercise or Activity
* Signed standardized informed consent
Exclusion Criteria
20 Years
45 Years
MALE
Yes
Sponsors
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Ministry of Defence, Norway
UNKNOWN
Haukeland University Hospital
OTHER
Responsible Party
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Locations
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Haukeland University Hospital
Bergen, , Norway
Countries
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Other Identifiers
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2014/691
Identifier Type: -
Identifier Source: org_study_id