Central Lines: Outcomes of Thrombosis and Sepsis study

Phase 2

Recruiting

• Conditions: Central venous catheter related thrombosis; Blood - Clotting disorders

• Registration Number: ACTRN12611000070932
• Lead Sponsor: Women's and Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-19
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Any thrombus, diagnosed by ultrasound (including echocardiography), in the vein into which the central venous catheter has been inserted.[Ultrasounds will be done between 24-72 hours of enrolment, weekly thereafter, and within 4 days of catheter removal. These latter may be the same: eg if a catheter is removed on day 6, the second, and final, ultrsound could be done between days 6-9. The final ultrasound is at day 28 if no clot has been found and the catheter is still in place.<br>Additional ultrasounds may be done at the treating team's discretion.]

Secondary Outcome Measures

Name	Time	Method
Clinically-apparent thrombosis at any time during the time the catheter is present.[Patients will be examined daily by a blinded doctor.];Catheter-related bloodstream infection[Any time the catheter is in place and 48 hours after its removal];Clinically-apparent thrombosis at any time during the time the catheter is present.[Patients will be examined daily by a blinded doctor.]