Microparticles in Scuba Divers With Decompression Sickness

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT01587209
Collaborator
Office of Naval Research (ONR) (U.S. Fed), University of Maryland (Other)
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Study Details

Study Description

Brief Summary

The investigators hypothesize that membrane microparticles (MPs) are liberated into the blood stream in response to decompression stress and that certain MPs characteristics initiate inflammatory responses that contribute to the clinical syndrome the investigators call decompression sickness. The research goal is to evaluate the number, type and time-course for elevations in MPs in sport SCUBA divers who present for treatment of decompression sickness. Blood samples are to be taken from consenting patients before and after they undergo treatment for decompression sickness and at a follow-up clinic visit from 1 to 3 weeks later (three samples total).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Microparticles (MPs) are small membrane bound vesicles shed from the surface of a variety of cells by what appear to be well regulated processes. They are elevated in many physiological and disease states and in some instances have been associated with organ injury. Shear stress

    • as can be caused by intravascular bubbles - is one of the stimuli known to cause cells to release microparticles. Most sport SCUBA dives have been shown to generate intravascular bubbles - even safe dives well within limits established by the US Navy and sports authorities. The investigators have reported elevations in several sub-types of MPs in a group of individuals undergoing a well monitored series of open-water SCUBA dives. There is no information of the occurrence of MPs in injured divers. The investigators have published results using a murine model which demonstrated that mice subjected to varying decompression stresses exhibit progressive elevations in circulating MPs derived from leukocytes, erythrocytes, platelets and endothelial cells. Using novel interventions the investigators demonstrated that MPs cause intravascular neutrophil activation and inflammatory perivascular injuries. Therefore, there is pathophysiological information to suggest that one or more element of MPs (number and/or pro-inflammatory subtype) may be proximal elements that precipitate the clinical syndrome the investigators call decompression sickness.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Phase 1 Study Investigating Alterations of Circulating Microparticles in Scuba Divers With Decompression Sickness
    Study Start Date :
    Aug 1, 2011
    Actual Primary Completion Date :
    Sep 1, 2014
    Actual Study Completion Date :
    Sep 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    Divers with decompression sickness

    The sole group under study is SCUBA divers who have sustained decompression sickness

    Outcome Measures

    Primary Outcome Measures

    1. Microparticle elevations in injured divers [four years]

      We will quantify microparticles in plasma by standard flow cytometry techniques.

    Secondary Outcome Measures

    1. Microparticle sub-types in injured divers [four years]

      We will evaluate sub-types of microparticles to determine their cells of origin.

    2. Neutrophil activation in injured divers [four years]

      We will evaluate presence of neutrophil activation in injured divers.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients who are given the diagnosis of decompression sickness will be offered entry into this study
    Exclusion Criteria:
    • Inability to provide informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pennsylvania Philadelphia Pennsylvania United States 19104-6068

    Sponsors and Collaborators

    • University of Pennsylvania
    • Office of Naval Research (ONR)
    • University of Maryland

    Investigators

    • Principal Investigator: Stephen R Thom, MD,PhD, University of Pennsylvania

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT01587209
    Other Study ID Numbers:
    • 814139
    First Posted:
    Apr 30, 2012
    Last Update Posted:
    Aug 22, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by University of Pennsylvania
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 22, 2016