RecruitingPhase 2Phase 3ACTRN12611000070932

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


Sponsor

Women's and Children's Hospital

Enrollment

100 participants

Start Date

Apr 1, 2010

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 0 YearssMax Age: 18 Yearss

Inclusion Criteria2

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

Exclusion Criteria8

  • 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

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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

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.


Locations(1)

Australia

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ACTRN12611000070932