- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04767113
Continuous Heparin Infusion to Prevent Catheter-related Thrombosis
A Randomized, Controlled Trial of Continuous Heparin Versus Placebo Infusion to Prevent Catheter-related Thrombosis in Infants After Cardiac Surgery
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guangdong
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Guangzhou, Guangdong, China, 510080
- Guangdong Provincial People's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- less than 3 months of age at admission, post-cardiac surgery, with CVC indwelled
Exclusion Criteria:
- parents' refusal, requiring postoperative anticoagulant administration (extracorporeal membrane oxygenation support, prosthetic devices), the contradiction to heparin (coagulopathy or hypercoagulable state, platelet level less than 50000/dL, clinically significant bleeding tendency, allergy to heparin)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Heparin group
Continuous infusion of heparin was used to maintain the patency of CVC.
|
For infants without thrombosis at enrollment, heparin 1 U/kg/h/line for term infants was used and 0.5 U/kg/h/line for preterm infants. The speed of infusion was 0.5ml/h. For infants with thrombosis at enrollment, heparin 10-15 U/kg/h for term infants was used with a target activated partial thromboplastin time 60-70s. Other interventions were at the clinical team's discretion under the local protocol.
Other Names:
|
PLACEBO_COMPARATOR: Control group
Continuous infusion of heparin was used at the corresponding speed.
|
For infants enrolled, normal saline was infused at the corresponding speed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
124 infants of CVC-related thrombosis by point-of-care echography or ultrasound
Time Frame: 30 days after cardiac surgery or at discharge, whichever comes first
|
CVC-related thrombosis of any catheter as imaged by echocardiogram or ultrasound at 30 days after cardiac surgery.
Thrombus was defined as an echogenic mass near the tip of the catheter or slow/no flow detected by Duplex and Doppler ultrasound at the nearby vessels and the on-site vessel couldn't be clasped as narrow as the collateral vessel by compression of the probe.
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30 days after cardiac surgery or at discharge, whichever comes first
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
124 infants of heparin-related comorbidity
Time Frame: 30 days after cardiac surgery or at discharge, whichever comes first
|
Abnormal coagulation and hemostasis were defined as treatment initiation by the clinical teams at the discretion of heparin adverse events.
Heparin-induced thrombocytopenia was confirmed with consistent low platelet level and positive enzyme-linked immunosorbent assay heparin-platelet factor 4 antibody assay.
Catheter-related sepsis was defined as culture of the same organism from both the catheter tip and at least one percutaneous blood culture.
Culture of the same organism from the catheter was also accepted as an alternative of culture of catheter tip.
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30 days after cardiac surgery or at discharge, whichever comes first
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-thrombotic syndrome
Time Frame: 6 months after cardiac surgery
|
The symptoms of post-thrombotic syndrome included aching, swelling, itchy and ulcer in the indwelling site and the collateral varicose veins.
|
6 months after cardiac surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Yunxia Sun, MD, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GPPH heparin for thrombosis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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