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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heparin group | Experimental | Continuous infusion of heparin was used to maintain the patency of CVC. |
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| Control group | Placebo Comparator | Continuous infusion of heparin was used at the corresponding speed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin sodium | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 days after cardiac surgery or at discharge, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-thrombotic syndrome | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yunxia Sun, MD | Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38934602 | Derived | Tan Y, Sun X, Zhong J, Zou Y, Ren Y, Liu Y, Zhao L, Zhuang J, Wang S, Sun Y, Wang Y. A Randomized, Controlled Trial of Continuous Heparin Infusion to Prevent Asymptomatic Catheter-related Thrombosis at Discharge in Infants After Cardiac Surgery: The CHIP-CRT Trial. J Pediatr Hematol Oncol. 2024 Aug 1;46(6):e406-e411. doi: 10.1097/MPH.0000000000002905. Epub 2024 Jun 25. |
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All data published and other related data were available after publication. No private information would be published.
From the date of publication to 5 years after publication.
Requests to the corresponding author were necessary.
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| ID | Term |
|---|---|
| D056824 | Upper Extremity Deep Vein Thrombosis |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000077324 | Crystalloid Solutions |
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Infant participants were blinded naturally, while ultrasonographers for central venous catheter (CVC)-related thrombosis were blinded, especially after interventions were stopped.
|
|
| Normal saline | Drug | For infants enrolled, normal saline was infused at the corresponding speed. |
|
| 30 days after cardiac surgery or at discharge, whichever comes first |
| D002318 |
| Cardiovascular Diseases |
| D007552 |
| Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |