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Markers of Central Nervous System Injury in Decompression Sickness (DCS NEURO)

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ClinicalTrials.gov Identifier: NCT03192956
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Anders Rosén, Sahlgrenska University Hospital, Sweden

Brief Summary:

Research hypothesis

  • There is a correlation between the quantity of fluid markers of CNS injury in blood and DCS.
  • There is a correlation between quantity and kind of fluid markers of CNS injury in blood and both diving profile and severity of DCS.
  • There is a correlation between the quantity of inflammatory markers in blood an DCS.

Objectives:

  • Assess whether individuals suffering decompression sickness exhibit fluid markers of central nervous system injury.
  • Evaluate the correlation between quantity and kind of fluid marker of CNS injury and clinical signs of neurological impairment.
  • Evaluate the correlation between quantity and kind of fluid marker of CNS injury and clinical outcome after 3-6 months.
  • Assess whether individuals suffering decompression sickness exhibit inflammatory markers in blood.

Condition or disease Intervention/treatment
Decompression Sickness Other: No active intervention

Detailed Description:

Decompression sickness (DCS) is a risk associated with diving. Common symptoms are joint and limb pain, skin rash, ataxia, hemiplegia, visual disturbances, paresthesias, limb numbness, nystagmus and vertigo. Treatment consists of recompression in a hyperbaric chamber, commonly referred to as hyperbaric oxygen treatment (HBOT).

It has been thought since the last quarter of the 19th century that DCS is caused by bubble formation in the tissues when dissolved inert gas comes out of solution. It was long thought that decompression schedules that did not give rise to any gas bubbles in the body also averted DCS. However, with the advent of ultrasound Doppler technology in the 1970s it was found that intravascular gas bubbles could exist even after uneventful dives. Dives well within limits established by military and sports authorities have been shown to generate intravascular bubbles. Hence, additional pathophysiological factors have been sought.

There is evidence of endothelial dysfunction, coagulopathy and inflammatory activation after diving. Though, their role in the pathophysiology of DCS remains to be determined.

Studies have shown that fluid markers of CNS injury can be found in blood samples obtained from athletes practising ice-hockey, boxing and american football. There is reason to believe that fluid markers of CNS injury will be present in blood samples obtained from divers with DCS as well.

Study subjects will be recruited by the attending physician at the Hyperbaric chamber at SU/Omrade 2 after the patient has been given a diagnosis of decompression sickness. Prior to treatment in the hyperbaric chamber, 4 ml of blood will be drawn via a plastic intravenous catheter that is placed in an arm vein as part of normal, established care of injured divers in the Emergency Department (to provide intravenous fluid and medications). A second 4 ml sample will be obtained from the same catheter after the patient has completed treatment (the typical hyperbaric treatment for decompression sickness lasts ~5.5 hours). The study object will also provide information regarding his/her general health and the completed dive. All study data, including blood samples, will anonymized and provided with a study code.

When feasible, blood samples will be obtained 1 week and 3-6 months after HBOT. These samples will be handled the same as the two obtained on the day of injury.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Neuroskademarkörer Vid Dykarsjuka
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : July 1, 2023
Estimated Study Completion Date : January 1, 2024

Intervention Details:
  • Other: No active intervention
    No active intervention is performed


Primary Outcome Measures :
  1. Biochemical signs of central nervous system injury [ Time Frame: 6 months ]
    E. g: Tau, NfL, GFAP, UCHL-1


Secondary Outcome Measures :
  1. Inflammatory activity [ Time Frame: 6 months ]
    E. g: VCAM-1, ICAM-1, Endothelin-1

  2. Symptoms of decompression sickness [ Time Frame: 24 hours ]
    Clinical diagnosis

  3. Dive time [ Time Frame: 1 hour ]
    Minutes

  4. Dive depth [ Time Frame: 1 hour ]
    Meters of seawater

  5. Remaining symptoms of decompression sickness after 3-6 months [ Time Frame: 6 months ]
    Clinical diagnosis


Biospecimen Retention:   Samples Without DNA
Serum. Plasma.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The research subjects are recruited, on voluntary basis, among divers with decompression sickness treated at the hyperbaric facility at Sahlgrenska Universuty Hospital.
Criteria

Inclusion Criteria:

  • Presence of decompression sickness
  • Signed informed consent

Exclusion Criteria:

  • As this is a highly selected population there is no exclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192956


Contacts
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Contact: Anders Rosén, MD +46725088800 anders.rosen@vgregion.se

Locations
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Sweden
Gothenburg University Recruiting
Gothenburg, Sweden, S-405 30
Contact: Henrik Zetterberg, PhD    +46313421000    henrik.zetterberg@gu.se   
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Göteborg University
Investigators
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Study Director: Henrik Zetterberg, PhD Göteborg University

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Responsible Party: Anders Rosén, MD PhD student, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT03192956     History of Changes
Other Study ID Numbers: EPN 552-16
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anders Rosén, Sahlgrenska University Hospital, Sweden:
Hyperbaric
Decompression sickness
Decompression injury
Inflammation
Central nervous injury
Hybervaric oxygen therapy

Additional relevant MeSH terms:
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Decompression Sickness
Barotrauma
Wounds and Injuries