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

August 20, 2020 updated by: Children's Hospital Medical Center, Cincinnati
To monitor changes in indicators of red cell damage such as extracellular hemoglobin, potassium (K-ABL), and lactate dehydrogenase (LD) post blast exposure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Childrens Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: subject blood drawns
subjects will have blood drawn which will then be exposed to blast via CO2 cartridge
Other: blood draw
subjects will have blood drawn done. This blood will then be exposed to blasting with CO2 cartridge

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lysis of blood cells
Time Frame: within 2 hours
measure the lysis of blood cells exposed to blast from CO2 cartridge
within 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 10, 2017

First Posted (Estimate)

January 12, 2017

Study Record Updates

Last Update Posted (Actual)

August 24, 2020

Last Update Submitted That Met QC Criteria

August 20, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-1087

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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