Clinical Trials Directory

Trials / Completed

CompletedNCT01587209

Microparticles in Scuba Divers With Decompression Sickness

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

Status
Completed
Phase
Study type
Observational
Enrollment
1 (actual)
Sponsor
University of Pennsylvania · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2011-08-01
Primary completion
2014-09-01
Completion
2014-09-01
First posted
2012-04-30
Last updated
2016-08-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01587209. Inclusion in this directory is not an endorsement.