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

Brain Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018548
• Other study ID #: 2014-1087
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: August 2020
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries

Intervention

Other:
• blood draw
subjects will have blood drawn done. This blood will then be exposed to blasting with CO2 cartridge

Locations

Country	Name	City	State
United States	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lysis of blood cells	measure the lysis of blood cells exposed to blast from CO2 cartridge	within 2 hours