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NCT Number: NCT04767113

Continuous Heparin Infusion to Prevent Catheter-related Thrombosis

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.

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Key information

Conditions

Cardiac Surgery Cardiovascular Diseases Central Venous Catheter Thrombosis Embolism and Thrombosis Heparin Thrombosis Upper Extremity Deep Vein Thrombosis Vascular Diseases Venous Thrombosis

Age range

Up to 3 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Other names: unfractionated heparin

normal saline

Drug

For infants enrolled, normal saline was infused at the corresponding speed.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Registry information

Official study title

A Randomized, Controlled Trial of Continuous Heparin Versus Placebo Infusion to Prevent Catheter-related Thrombosis in Infants After Cardiac Surgery

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2021
Registry last updated
Sep 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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