Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000442505
Ethics application status
Approved
Date submitted
16/04/2015
Date registered
7/05/2015
Date last updated
15/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
What is the frequency of central venous catheter-related venous thrombosis in children?
Scientific title
Frequency of and risk factors for central venous catheter-related venous thrombosis in children.
Secondary ID [1] 286220 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous thrombosis in children 294267 0
Condition category
Condition code
Anaesthesiology 294585 294585 0 0
Other anaesthesiology
Cardiovascular 294586 294586 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 294603 294603 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study.

The primary outcome of the study is the frequency of central venous catheter-related venous thrombosis in children receiving central venous catheters at Astrid Lindgrens Children´s Hospital.
All children receiving central venous catheters at Astrid Lindgrens Children´s Hospital will be included in the study.

Blood sampling for coagulation tests will be obtained at the insertion and extraction of the central venous catheter (CVC). Patients will be followed for clinical signs of CVC-related venous thrombosis as long as the central venous catheter is in place. Ultrasonography will be used to detect asymptomatic thrombosis at the time of CVC removal.

Patients will be followed until hospital discharge. Patients that develop CVC-related thrombosis will be followed until the end of treatment.
Intervention code [1] 291237 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294355 0
Frequency of central venous catheter-related venous thrombosis assessed by ultrasonography.
Timepoint [1] 294355 0
Duration of CVC
Secondary outcome [1] 313089 0
PICU length of stay, data from medical records.
Timepoint [1] 313089 0
PICU discharge
Secondary outcome [2] 313090 0
Hospital length of stay, data from medical records.
Timepoint [2] 313090 0
Hospital discharge
Secondary outcome [3] 313091 0
Time on mechanical ventilation, data from medical records.
Timepoint [3] 313091 0
PICU discharge
Secondary outcome [4] 313092 0
In-hospital mortality, data from medical records.
Timepoint [4] 313092 0
Hospital discharge
Secondary outcome [5] 314443 0
Short term (in-hospital) complications of venous thrombosis, data from medical records.
Timepoint [5] 314443 0
Hospital discharge

Eligibility
Key inclusion criteria
Patients with a central venous catheter
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- No informed consent.
- Previous thrombosis in the CVC-vein.
- Death is deemed imminent and inevitable.
- CVC inserted during ECMO-treatment

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Non-parametric statistics will be used to investigate differences between patients with and without CVC-related venous thrombosis. Multivariate analysis will be used to identify risk factors for venous thrombosis.
he number of participants was chosen based on the expected number of patients meeting inclusion criteria during 12 months in Astrid Lindgren´s Children Hospital.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/04/2015
Actual
20/04/2015
Date of last participant enrolment
Anticipated
Actual
12/06/2016
Date of last data collection
Anticipated
Actual
31/08/2016
Sample size
Target
240
Accrual to date
Final
252
Recruitment outside Australia
Country [1] 6677 0
Sweden
State/province [1] 6677 0

Funding & Sponsors
Funding source category [1] 290785 0
Hospital
Name [1] 290785 0
Astrid Lindgren Children´s Hospital (Karolinska University Hospital)
Country [1] 290785 0
Sweden
Primary sponsor type
Individual
Name
Andreas Andersson
Address
Department of Paediatric Anaesthesia and Intensive Care
Astrid Lindgrens Children´s Hospital
S-17176 Stockholm
Country
Sweden
Secondary sponsor category [1] 289469 0
None
Name [1] 289469 0
Address [1] 289469 0
Country [1] 289469 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292681 0
Central ethical review board
Ethics committee address [1] 292681 0
FE 289
S-171 77 STOCKHOLM
Ethics committee country [1] 292681 0
Sweden
Date submitted for ethics approval [1] 292681 0
Approval date [1] 292681 0
20/03/2015
Ethics approval number [1] 292681 0

Summary
Brief summary
This study investigates the frequency of central venous catheter-related venous thrombosis in children. Further, we want to describe risk factors for the development of central venous catheter-related venous thrombosis in children and short term complications of thrombosis.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55142 0
Dr Andreas Andersson
Address 55142 0
Department of Paediatric Anaesthesia and Intensive Care
Astrid Lindgrens Children´s Hospital
S-17176 Stockholm
Country 55142 0
Sweden
Phone 55142 0
+46704997886
Fax 55142 0
Email 55142 0
andreas.andersson@karolinska.se
Contact person for public queries
Name 55143 0
Dr Andreas Andersson
Address 55143 0
Department of Paediatric Anaesthesia and Intensive Care
Astrid Lindgrens Children´s Hospital
S-17176 Stockholm
Country 55143 0
Sweden
Phone 55143 0
+46704997886
Fax 55143 0
Email 55143 0
andreas.andersson@karolinska.se
Contact person for scientific queries
Name 55144 0
Dr Andreas Andersson
Address 55144 0
Department of Paediatric Anaesthesia and Intensive Care
Astrid Lindgrens Children´s Hospital
S-17176 Stockholm
Country 55144 0
Sweden
Phone 55144 0
+46704997886
Fax 55144 0
Email 55144 0
andreas.andersson@karolinska.se

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No Supporting Document Provided



Results publications and other study-related documents

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