Microparticles in Scuba Divers With Decompression Sickness

NCT01587209 | Completed

• 1 other identifier: 814139
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

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).

Conditions

Decompression Sickness; Dysbarism

Keywords

decompression; intravascular bubbles; neutrophil activation

Outcome Measures

Primary Outcomes (1)

• Microparticle elevations in injured divers

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

  four years

Secondary Outcomes (2)

• Microparticle sub-types in injured divers

  four years

• Neutrophil activation in injured divers

  four years

Study Arms (1)

Divers with decompression sickness

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SCUBA divers over age 21 that present for evaluation of suspected decompression sickness

You may qualify if:

• Patients who are given the diagnosis of decompression sickness will be offered entry into this study

You may not qualify if:

• Inability to provide informed consent

Sponsors & Collaborators

• University of Pennsylvania: lead
• Office of Naval Research (ONR): collaborator
• University of Maryland: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-6068, United States

Location

Related Publications (3)

• Thom SR, Yang M, Bhopale VM, Huang S, Milovanova TN. Microparticles initiate decompression-induced neutrophil activation and subsequent vascular injuries. J Appl Physiol (1985). 2011 Feb;110(2):340-51. doi: 10.1152/japplphysiol.00811.2010. Epub 2010 Oct 21.

  PMID: 20966192 BACKGROUND

• Yang M, Milovanova TN, Bogush M, Uzun G, Bhopale VM, Thom SR. Microparticle enlargement and altered surface proteins after air decompression are associated with inflammatory vascular injuries. J Appl Physiol (1985). 2012 Jan;112(1):204-11. doi: 10.1152/japplphysiol.00953.2011. Epub 2011 Sep 29.

  PMID: 21960660 BACKGROUND

• Thom SR, Milovanova TN, Bogush M, Bhopale VM, Yang M, Bushmann K, Pollock NW, Ljubkovic M, Denoble P, Dujic Z. Microparticle production, neutrophil activation, and intravascular bubbles following open-water SCUBA diving. J Appl Physiol (1985). 2012 Apr;112(8):1268-78. doi: 10.1152/japplphysiol.01305.2011. Epub 2012 Feb 9.

  PMID: 22323646 BACKGROUND

MeSH Terms

Conditions

Decompression Sickness; Barotrauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Stephen R Thom, MD,PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2012
• First Posted: April 30, 2012
• Study Start: August 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: August 22, 2016

Record last verified: 2016-08

Locations

US (1)