Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06207396
Status:
RECRUITING
Last Update Posted:
2024-01-17
First Post:
2023-12-05
Brief Title:
Characteristics of Spiking in Ghent a Multicentric Prospective Observational Study
Sponsor:
University Hospital Ghent
Organization:
University Hospital Ghent
Study Overview
Official Title:
Characteristics of Spiking in Ghent A Multicentric Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to document the incidence and characteristics of spiking in the Ghent region both anamnestically and by toxicological analysis
Spiking will be analyzed by immunoassay testing and high-resolution screening according to the protocol in the laboratory of UZ Gent
Spiking will be analyzed by immunoassay testing and high-resolution screening according to the protocol in the laboratory of UZ Gent
Detailed Description:
This study aims at objectivating and characterizing the patients with alleged spiking in the city of Ghent
Every patient who presents at one of the four out of four emergency departments of Ghent with a suspicion of spiking drinkfoodneedle-spiking included will be offered to take part of this study
The study entails a list of questions for the patient regarding demographics recent own medicationdrugalcohol use and experienced symptoms whilst the caregiver doctornurse completes a questionnaire regarding symptoms at time of presentation
For a presentation within 48h after event both blood and urine samples are requested from the patient When presenting between 48h and 96h after the event only urine samples are requested
On this samples IA and LC-GCMS according to the UNODOC standards Guidelines for the Forensic analysis of drugs facilitating sexual assault and other criminal acts to objectify exogenous products
On request of the patient these results can be added to the medical file of the patient
Every patient who presents at one of the four out of four emergency departments of Ghent with a suspicion of spiking drinkfoodneedle-spiking included will be offered to take part of this study
The study entails a list of questions for the patient regarding demographics recent own medicationdrugalcohol use and experienced symptoms whilst the caregiver doctornurse completes a questionnaire regarding symptoms at time of presentation
For a presentation within 48h after event both blood and urine samples are requested from the patient When presenting between 48h and 96h after the event only urine samples are requested
On this samples IA and LC-GCMS according to the UNODOC standards Guidelines for the Forensic analysis of drugs facilitating sexual assault and other criminal acts to objectify exogenous products
On request of the patient these results can be added to the medical file of the patient
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None