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OpenTrials
Completed

NCT Number: NCT01587209

Microparticles in Scuba Divers With Decompression Sickness

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6068, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Microparticle elevations in injured divers

    Time frame: four years

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

Secondary outcomes

  1. Microparticle sub-types in injured divers

    Time frame: four years

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

  2. Neutrophil activation in injured divers

    Time frame: four years

    We will evaluate presence of neutrophil activation in injured divers.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 30, 2012
Registry last updated
Aug 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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