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Central Lines: Outcomes of Thrombosis and Sepsis study

A randomised, controlled trial of low dose intravenous heparin in children with CVCs: effect on thrombosis and infection rates

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000070932
Acronym
CLOTS
Enrollment
100
Registered
2011-01-19
Start date
2010-04-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

We plan to test the hypothesis that, in children with central lines admitted to intensive care, intravenous (through a drip) heparin at a low dose prevents clots developing around the central line, compared to saline, an inactive placebo. Clots will be sought using ultrasound.

Interventions

Intravenous unfractionated heparin 10 units per kilogram per hour started <12hours after central venous catheter insertion and continued while the catheter is in place. Route of insertion (femoral or internal jugular) is at the physician's discretion.

Sponsors

Women's and Children's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
0 to 18 Years
Healthy volunteers
No

Inclusion criteria

Children 0-18 years old Central venous catheter inserted and likely to be in place >24 hours

Exclusion criteria

CVCs inserted surgically e.g. Brouviac or Hickman CVCs or subcutaneous ports. Percutaneously central catheters (PICC) inserted via a peripheral vein. Subclavian CVCs Patients with a known thrombophilia, coagulopathy (APTT (activated partial thromboplastin time)>50 s for >30 days old, >55 s for =30 days old ) or receiving anticoagulant medication, other than low dose heparin. For intravenous heparin, low dose means = 3 U/kg/hour, used to maintain CVC patency. Patients with a platelet count of <50 000 x 109 /L Patients who have known central vein thrombosis in the affected vein. Patients who have already participated in the study. The unit of randomisation is patient, not catheter. Patients with a known allergy to heparin, or with a past history of heparin-induced thrombocytopaenia

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026