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Clinical Trials/NCT03018548
NCT03018548CompletedNot Applicable

Improvised Explosive Device (IED) Level Blasting of Human Blood With Slosh Prevention

Children's Hospital Medical Center, Cincinnati2 sites in 1 country40 target enrollmentStarted: January 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
2
Primary Endpoint
Lysis of blood cells

Study Overview

Brief Summary

To monitor changes in indicators of red cell damage such as extracellular hemoglobin, potassium (K-ABL), and lactate dehydrogenase (LD) post blast exposure.

Detailed Description

Traumatic brain injury (TBI) causes significant morbidity and mortality, accompanied by high related costs. Recent hypotheses concerning the pathophysiology of TBI invoke Strain Shear Theory and Cavitation Theory. The invbestigators propose to test the importance of the latter by directing blast waves into containers that are either partially or completely filled with blood and measuring markers of lysis.

These experiments are designed to better understand the demonstrated effectiveness of mild jugular compression according to the principle of the Queckenstedt Maneuver to reduce the likelihood of TBI by filling up the compliance of the cranial space. A device (C-Collar) is being developed by Q30 Labs, LLC (Q30), to accomplish this effect.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • • Normal healthy volunteer
  • Able to provide written consent
  • Must be 18 years or older

Exclusion Criteria

  • • Unable to provide written consent
  • Recent penetrating brain trauma (within 6 months)
  • Under the age of 18 years

Outcomes

Primary Outcomes

Lysis of blood cells

Time Frame: within 2 hours

measure the lysis of blood cells exposed to blast from CO2 cartridge

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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