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

Primary Purpose

Brain Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
blood draw
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Brain Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Cincinnati Childrens Hospital Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

subject blood drawns

Arm Description

subjects will have blood drawn which will then be exposed to blast via CO2 cartridge

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 10, 2017
Last Updated
August 20, 2020
Sponsor
Children's Hospital Medical Center, Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT03018548
Brief Title
Improvised Explosive Device (IED) Level Blasting of Human Blood With Slosh Prevention
Official Title
Improvised Explosive Device (IED) Level Blasting of Human Blood With Slosh Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
subject blood drawns
Arm Type
Experimental
Arm Description
subjects will have blood drawn which will then be exposed to blast via CO2 cartridge
Intervention Type
Other
Intervention Name(s)
blood draw
Intervention Description
subjects will have blood drawn done. This blood will then be exposed to blasting with CO2 cartridge
Primary Outcome Measure Information:
Title
Lysis of blood cells
Description
measure the lysis of blood cells exposed to blast from CO2 cartridge
Time Frame
within 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory D Myer, PhD
Organizational Affiliation
Cincinnati Childrens Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cincinnati Childrens Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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