Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
Study NCT ID:
NCT03976557
Status:
TERMINATED
Last Update Posted:
2021-01-22
First Post:
2019-06-04
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden
Sponsor:
Bactiguard AB
Organization:
Study Overview
Official Title:
Implementation and Evaluation of BIP CVC in Access Center at Danderyd Hospital, Stockholm, Sweden. Study Protocol
Status:
TERMINATED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to Corona/Covid19 pandemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPROWE
Brief Summary:
Primary objective of the study is to establish the incidence of all any catheter related complications in BIP CVC and standard CVC groups in patients requiring CVC.
(CVC - Central Venous Catheter; BIP - Bactiguard Infection Protection)
(CVC - Central Venous Catheter; BIP - Bactiguard Infection Protection)
Detailed Description:
Catheter related complications include CRBSI, CRI, Local CVC infection, need to exchange of CVC due to suspected CRI/CRBSI or thrombosis, stop / slower flow in any CVC lumen, local thrombosis, device malfunctions / technical catheter problems, device related adverse events.
(CRBSI - Catheter Related Blood Stream Infection; CRI - Catheter Related Infection)
(CRBSI - Catheter Related Blood Stream Infection; CRI - Catheter Related Infection)
Study Oversight
Has Oversight DMC:
False
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?: