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Microparticles in Scuba Divers With Decompression Sickness

Phase 1 Study Investigating Alterations of Circulating Microparticles in Scuba Divers With Decompression Sickness

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01587209
Enrollment
1
Registered
2012-04-30
Start date
2011-08-31
Completion date
2014-09-30
Last updated
2016-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decompression Sickness, Dysbarism

Keywords

decompression, intravascular bubbles, neutrophil activation

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).

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.

Interventions

None listed

Sponsors

Office of Naval Research (ONR)
CollaboratorFED
University of Maryland
CollaboratorOTHER
University of Pennsylvania
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Microparticle elevations in injured diversfour yearsWe will quantify microparticles in plasma by standard flow cytometry techniques.

Secondary

MeasureTime frameDescription
Microparticle sub-types in injured diversfour yearsWe will evaluate sub-types of microparticles to determine their cells of origin.
Neutrophil activation in injured diversfour yearsWe will evaluate presence of neutrophil activation in injured divers.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026