Continuous Heparin Infusion to Prevent Catheter-related Thrombosis

Guangdong Provincial People's Hospital (Guangdong Provincial Academy of Medical Sciences)

Status: Completed

Conditions: Cardiac Surgery; Heparin; Central Venous Catheter Thrombosis

Treatments: Drug: Normal saline; Drug: Heparin sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT04767113

GPPH heparin for thrombosis

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 35 patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

35 participants in 2 patient groups, including a placebo group

Heparin group

Experimental group

Description:

Continuous infusion of heparin was used to maintain the patency of CVC.

Treatment:

Drug: Heparin sodium

Control group

Placebo Comparator group

Description:

Continuous infusion of heparin was used at the corresponding speed.

Treatment:

Drug: Normal saline