Comparison of Different CSF Sampling Sites on External Ventricular Drains

NCT05254353 | Recruiting

• 1 other identifier: S65845
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the current study is to evaluate the difference between proximal and distal CSF sampling. If the characteristics of distally and proximally sampled CSF are similar or correlate well, it may be possible to only sample CSF distally in the future, thereby avoiding the risks mentioned above.

Conditions

Cerebrospinal Fluid

Keywords

neurosurgery; CSF; EVD

Outcome Measures

Primary Outcomes (1)

• Change of the CSF white cell count at day 1-4 and day 5-9 when comparing both sampling methods

  The aim of the current study is to evaluate the difference between proximal and distal CSF sampling.

  Day 1-4 and day 5-9 after placement of EVD

Secondary Outcomes (9)

• White cell count correlation for all the available time points

  Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)

• Gram stain correlation for all the available time points

  Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)

• Culture correlation for all the available time points

  Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)

• Protein correlation for all the available time points

  Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)

• Glucose correlation for all the available time points

  Samples will be taken every 2-3 days after placement until removal of EVD (estimated between 7 and 28 days)

Study Arms (1)

Patients with EVD

Procedure: Analyses of proximal and distal samples

Interventions

Analyses of proximal and distal samples PROCEDURE

Evaluate the difference between proximal and distal CSF samples

Patients with EVD

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with an external ventricular drain (EVD) presenting to the Neurosurgery ward.

You may qualify if:

• Patients with an EVD in place regardless of the underlying pathology.
• Written informed consent to participate in the study must be obtained from the subject. If the subject is not capable of self-consent, all efforts will be made to locate a legally acceptable representative to act on behalf of the subject.
• When the patient is considered capable to consent but physically unable to sign an informed consent form and a representative is not available an impartial witness can attend the informed consent process.
• \- Males and females of all ages, including children and pregnant females

You may not qualify if:

• Patients in whom the removal of the drain is planned within 48 hours, before routine sampling, will be excluded.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

CSF

Study Officials

• Philippe De Vloo, prof.dr.

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe De Vloo, prof.dr.

CONTACT

016 344290; neurochirurgie@uzleuven.be

Tom Deleu, dr.

CONTACT

016 344290; neurochirurgie@uzleuven.be

Study Design

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

Study Record Dates

• First Submitted: January 19, 2022
• First Posted: February 24, 2022
• Study Start: January 31, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 1, 2024

Record last verified: 2024-06

Locations

BE (1)