NCT03192956

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 14, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

8.1 years

First QC Date

June 14, 2017

Last Update Submit

December 7, 2023

Conditions

Decompression Sickness

Keywords

HyperbaricDecompression sicknessDecompression injuryInflammationCentral nervous injuryHybervaric oxygen therapy

Outcome Measures

Primary Outcomes (1)

  • Biochemical signs of central nervous system injury

    E. g: Tau, NfL, GFAP, UCHL-1

    6 months

Secondary Outcomes (5)

  • Inflammatory activity

    6 months

  • Symptoms of decompression sickness

    24 hours

  • Dive time

    1 hour

  • Dive depth

    1 hour

  • Remaining symptoms of decompression sickness after 3-6 months

    6 months

Interventions

No active interventionOTHER

No active intervention is performed

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Presence of decompression sickness
  • Signed informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gothenburg University

Gothenburg, S-405 30, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum. Plasma.

MeSH Terms

Conditions

Decompression SicknessInflammation

Condition Hierarchy (Ancestors)

BarotraumaWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Henrik Zetterberg, PhD

    Göteborg University

    STUDY DIRECTOR

Central Study Contacts

Anders Rosén, PhD

CONTACT

+46725088800bandersrosen@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

June 14, 2017

First Posted

June 20, 2017

Study Start

May 1, 2017

Primary Completion

June 1, 2025

Study Completion

December 30, 2025

Last Updated

December 14, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)