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A randomized controlled study of heparin versus low molecular weight heparin in preventing catheter-related thrombosis in neonates after congenital heart disease surgery

A randomized controlled study of heparin versus low molecular weight heparin in preventing catheter-related thrombosis in neonates after congenital heart disease surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103331
Enrollment
Unknown
Registered
2025-05-28
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal catheter-related thrombosis

Interventions

Heparin prevention group:The heparin prevention group was given continuous intravenous infusion of heparin at the beginning, with an initial dose of 5-10u/kg?h. APTT was monitored every 24 hours (targ
Low molecular weight heparin prevention group:The low molecular weight heparin prevention group received nadroparin calcium, 0.75 mg/kg, subcutaneously twice a day. Blood was collected 4 hours after a

Sponsors

Fujian Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Newborns diagnosed with congenital heart disease who need to have a CVC catheter placed for the first time after surgery (gestational age >= 37 weeks, birth weight >= 2500g);

Exclusion criteria

Exclusion criteria: Parents refused to participate in the study; there were contraindications to heparin/low molecular weight heparin (such as platelet count 50s, active bleeding, abnormal liver and kidney function [ALT>2 times the upper limit of normal, Cr>1.5mg/dL]); ECMO support or planned secondary surgery was required after surgery; combined with hereditary thrombotic diseases or congenital coagulation factor abnormalities; received other anticoagulant/antiplatelet therapy within 72 hours before or after surgery; had infective endocarditis or sepsis; CVC flushing solution was not normal saline; vasoactive drug infusion was not through the proximal port of the CVC (=5cm from the tip of the catheter) or there was multi-channel mixed infusion (such as vasoactive drugs and nutrient solution sharing the same line).

Design outcomes

Primary

MeasureTime frame
The incidence of catheter-related thrombosis;

Secondary

MeasureTime frame
Incidence of bleeding events;Drug-related adverse reactions;

Countries

China

Contacts

Public ContactYirong Zheng

Fujian children’s hospital

zhengyirong2020@163.com+86 152 8042 4149

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026