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

Plain Language Summary

Simplified for easier understanding

Children in intensive care often have a central line — a tube placed into a large vein to deliver medications. These lines can sometimes cause dangerous blood clots. This study is testing whether giving a very low dose of heparin (a blood-thinning medication) through the central line prevents clots from forming, compared to saline (a saltwater solution with no active drug). Researchers use ultrasound to check for clots. The goal is to keep the line working safely and avoid serious complications. You may be eligible if: - You are a child between 0 and 18 years old - You have a central venous catheter (CVC) that is expected to be in place for more than 24 hours - You are admitted to a pediatric intensive care unit You may NOT be eligible if: - Your catheter was placed surgically (such as a Broviac or Hickman line) or is a subcutaneous port - Your catheter is a peripherally inserted central catheter (PICC line) - Your catheter is in the subclavian vein - You have a known blood clotting disorder or are on anticoagulant medication (other than standard low-dose heparin for line maintenance) - Your platelet count is very low (below 50,000) - You already have a known blood clot in the affected vein - You have a known allergy to heparin or have previously had heparin-induced low platelet counts Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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