Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000070932
Ethics application status
Approved
Date submitted
16/03/2010
Date registered
19/01/2011
Date last updated
19/01/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Central Lines: Outcomes of Thrombosis and Sepsis study
Scientific title
A randomised, controlled trial of low dose intravenous heparin in children with CVCs: effect on thrombosis and infection rates
Secondary ID [1] 252956 0
None
Secondary ID [2] 252957 0
None
Universal Trial Number (UTN)
U1111-1113-8041
Trial acronym
CLOTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central venous catheter related thrombosis 256970 0
Condition category
Condition code
Blood 257114 257114 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256147 0
Prevention
Intervention code [2] 257485 0
Treatment: Drugs
Comparator / control treatment
Intravenous normal saline at the same fluid infusion flow rate
Control group
Placebo

Outcomes
Primary outcome [1] 258016 0
Any thrombus, diagnosed by ultrasound (including echocardiography), in the vein into which the central venous catheter has been inserted.
Timepoint [1] 258016 0
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.
Additional ultrasounds may be done at the treating team's discretion.
Secondary outcome [1] 263568 0
Clinically-apparent thrombosis at any time during the time the catheter is present.
Timepoint [1] 263568 0
Patients will be examined daily by a blinded doctor.
Secondary outcome [2] 263569 0
Catheter-related bloodstream infection
Timepoint [2] 263569 0
Any time the catheter is in place and 48 hours after its removal
Secondary outcome [3] 263582 0
Clinically-apparent thrombosis at any time during the time the catheter is present.
Timepoint [3] 263582 0
Patients will be examined daily by a blinded doctor.

Eligibility
Key inclusion criteria
Children 0-18 years old
Central venous catheter inserted and likely to be in place >24 hours
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible, consented patients will have the next available envelope drawn from the appropriate box (defined by strata). Envelopes will be double and opaque, with a paper slip with grey font inside naming the group to which they are assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation, with variable block sizes
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Pilot study to test feasiblity initially
Stratified by one of three centres and by vein used for catheterisation: femoral or internal jugular
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256653 0
Charities/Societies/Foundations
Name [1] 256653 0
Women's and Children's Foundation
Country [1] 256653 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
72 Kingwilliam Road
North Adelaide SA 5006
Country
Australia
Secondary sponsor category [1] 255940 0
Hospital
Name [1] 255940 0
Royal Children's Hospital Brisbane
Address [1] 255940 0
158 Butterfield St
Herston QLD 4006
Country [1] 255940 0
Australia
Secondary sponsor category [2] 255941 0
Hospital
Name [2] 255941 0
Princess Margaret Hospital Perth
Address [2] 255941 0
Princess Margaret Hospital
Roberts Road, Subiaco, Perth
Western Australia 6008
Country [2] 255941 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258680 0
Children's Youth and Women's Health Service Human Research Ethics Committee
Ethics committee address [1] 258680 0
Women's and Children's Hospital
72 Kingwilliam Road
North Adelaide SA 5006
Ethics committee country [1] 258680 0
Australia
Date submitted for ethics approval [1] 258680 0
Approval date [1] 258680 0
18/12/2010
Ethics approval number [1] 258680 0
12/12/2234

Summary
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.
Trial website
none
Trial related presentations / publications
none
Public notes

Contacts
Principal investigator
Name 30937 0
Address 30937 0
Country 30937 0
Phone 30937 0
Fax 30937 0
Email 30937 0
Contact person for public queries
Name 14184 0
Georgia Letton
Address 14184 0
Paediatric intensive care unit
Women's and Children's Hospital
72 Kingwilliam road
North Adelaide SA 5006
Country 14184 0
Australia
Phone 14184 0
+61 881616204
Fax 14184 0
Email 14184 0
[email protected]
Contact person for scientific queries
Name 5112 0
Michael Yung
Address 5112 0
Paediatric intensive care unit
Women's and Children's Hospital
72 Kingwilliam road
North Adelaide SA 5006
Country 5112 0
Australia
Phone 5112 0
+61 881616204
Fax 5112 0
Email 5112 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.