Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04767113
Status:
COMPLETED
Last Update Posted:
2022-09-02
First Post:
2021-02-06
Brief Title:
Continuous Heparin Infusion to Prevent Catheter-related Thrombosis
Sponsor:
Guangdong Provincial Peoples Hospital
Organization:
Guangdong Provincial Peoples Hospital
Study Overview
Official Title:
A Randomized Controlled Trial of Continuous Heparin Versus Placebo Infusion to Prevent Catheter-related Thrombosis in Infants After Cardiac Surgery
Status:
COMPLETED
Status Verified Date:
2022-09
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:
Catheter-related thrombosis could impair blood flow in the vein block the central venous catheter induce catheter-related infection or venous thromboembolism in the deep veins or pulmonary vessels which furthermore progress into the post-thrombotic syndrome
Researches using echogenic mass as the primary outcome could miss those premature thrombi which might not be seen on traditional ultrasonography but may be detected by Duplex and Doppler ultrasound with vessel compression Moreover studies indicated that some thrombus developed after the catheter removal Removal of the catheter is not the endpoint of thrombus detection This study is designed to determine the preventive effects of continuous heparin infusion on real-world central venous catheter-related thrombosis in infants after cardiac surgery
Researches using echogenic mass as the primary outcome could miss those premature thrombi which might not be seen on traditional ultrasonography but may be detected by Duplex and Doppler ultrasound with vessel compression Moreover studies indicated that some thrombus developed after the catheter removal Removal of the catheter is not the endpoint of thrombus detection This study is designed to determine the preventive effects of continuous heparin infusion on real-world central venous catheter-related thrombosis in infants after cardiac surgery
Detailed Description:
Catheter-related thrombosis could impair blood flow in the vein block the central venous catheter induce catheter-related infection or venous thromboembolism in the deep veins or pulmonary vessels which furthermore progress into the post-thrombotic syndrome Researches using echogenic mass as the primary outcome could miss those premature thrombi which might not be seen on traditional ultrasonography but may be detected by Duplex and Doppler ultrasound with vessel compression Moreover studies indicated that some thrombus developed after the catheter removal Removal of the catheter is not the endpoint of thrombus detection This study is designed to determine the preventive effects of continuous heparin infusion on real-world central venous catheter-related thrombosis in infants after cardiac surgery One hundred and twenty-four infants were randomized to the intervention group or the control group Unfractionated heparin or normal saline was infused continuously through each lumen of the central venous catheter at the speed of 05 mlhline until the catheter was removed Catheter-related thrombosis was detected by point-of-care Duplex and Doppler ultrasound periodically until 30 days after the cardiac surgery or discharge whichever comes first
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