Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05948514
Status:
COMPLETED
Last Update Posted:
2023-07-17
First Post:
2023-07-05
Brief Title:
Complications Related to Vascular Access Devices in Home Parenteral Nutrition Patients
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Venous Thromboembolism and Infections Associated With Three Vascular Access Devices in Home Parenteral Nutrition a Prospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2023-07
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:
CRVADHPNP
Brief Summary:
Central vascular access devices are required for home parenteral nutrition HPN There is few data available concerning their complications in adult HPN patients and the potential link between venous thromboembolism and catheter infection is not well established
The aim of this prospective cohort study is to compare the incidence rate of catheter related complications among 3 types of central vascular access peripherally inserted central catheters tunneled catheters and port-a-cath devices in adults patients on HPN describe the risk factors and identify a potential link between venous thromboembolism and infection
More than 300 patients will be consecutively enrolled and followed up from the time of catheter insertion until its removal Venous complication identify by an ultrasound examination if deep vein thrombosis is suspected infection related to catheter and mechanical complications will be analyzed The incidence of complications will be expressed per 1000 catheters-day and or as a percentage of total catheter
The aim of this prospective cohort study is to compare the incidence rate of catheter related complications among 3 types of central vascular access peripherally inserted central catheters tunneled catheters and port-a-cath devices in adults patients on HPN describe the risk factors and identify a potential link between venous thromboembolism and infection
More than 300 patients will be consecutively enrolled and followed up from the time of catheter insertion until its removal Venous complication identify by an ultrasound examination if deep vein thrombosis is suspected infection related to catheter and mechanical complications will be analyzed The incidence of complications will be expressed per 1000 catheters-day and or as a percentage of total catheter
Detailed Description:
None
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