An interventional study of Heparin sodium and Normal saline in Cardiac Surgery, Central Venous Catheter Thrombosis and Heparin, sponsored by Guangdong Provincial People's Hospital. Completed at 1 site in China. Open to participants aged Up to 3 Months. Per ClinicalTrials.gov, last updated 2022-09-02.
Sponsored by Guangdong Provincial People's Hospital · Not applicable, Interventional, and Prevention
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.
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 0.5 ml/h/line 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.
1,506 studies on the registry are indexed under Thrombosis; 238 are open to participants now.
This study's enrollment of 35 is below the median of 106 across 849 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →Guangdong Provincial People's Hospital is the lead sponsor of 231 studies on the registry; 101 are open to participants now.
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Exclusion Criteria:
Continuous infusion of heparin was used to maintain the patency of CVC.
Drug: Heparin sodium
Continuous infusion of heparin was used at the corresponding speed.
Drug: Normal saline
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.
Also known as: unfractionated heparin
For infants enrolled, normal saline was infused at the corresponding speed.
124 infants of CVC-related thrombosis by point-of-care echography or ultrasound
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.
Time frame: 30 days after cardiac surgery or at discharge, whichever comes first
124 infants of heparin-related comorbidity
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.
Time frame: 30 days after cardiac surgery or at discharge, whichever comes first
Post-thrombotic syndrome
The symptoms of post-thrombotic syndrome included aching, swelling, itchy and ulcer in the indwelling site and the collateral varicose veins.
Time frame: 6 months after cardiac surgery
Plan to share: Yes — All data published and other related data were available after publication. No private information would be published.
Supporting information: Study protocol, Sap, Icf, Csr
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Guangdong Provincial People's Hospital