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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ANZCTR |
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Last refreshed on:
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13 January 2020 |
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Main ID: |
ACTRN12615000442505 |
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Date of registration:
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07/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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What is the frequency of central venous catheter-related venous thrombosis in children?
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Scientific title:
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Frequency of and risk factors for central venous catheter-related venous thrombosis in children. |
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Date of first enrolment:
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20/04/2015 |
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Target sample size:
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240 |
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Recruitment status: |
Completed |
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URL:
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https://anzctr.org.au/ACTRN12615000442505.aspx |
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Study type:
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Observational |
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Study design:
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Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Prospective;
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Phase:
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Not Applicable
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Dr Andreas Andersson
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Address:
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Department of Paediatric Anaesthesia and Intensive Care
Astrid Lindgrens Children´s Hospital
S-17176 Stockholm
Sweden |
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Telephone:
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+46704997886 |
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Email:
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andreas.andersson@karolinska.se |
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Affiliation:
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Name:
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Dr Andreas Andersson
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Address:
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Department of Paediatric Anaesthesia and Intensive Care
Astrid Lindgrens Children´s Hospital
S-17176 Stockholm
Sweden |
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Telephone:
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+46704997886 |
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Email:
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andreas.andersson@karolinska.se |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients with a central venous catheter
Exclusion criteria: - No informed consent.
- Previous thrombosis in the CVC-vein.
- Death is deemed imminent and inevitable.
- CVC inserted during ECMO-treatment
Age minimum:
No limit
Age maximum:
18 Years
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Anaesthesiology - Other anaesthesiology
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Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system
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Blood - Clotting disorders
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Venous thrombosis in children;
Venous thrombosis in children
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Intervention(s)
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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.
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Primary Outcome(s)
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Frequency of central venous catheter-related venous thrombosis assessed by ultrasonography.[Duration of CVC]
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Secondary Outcome(s)
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Hospital length of stay, data from medical records.[Hospital discharge]
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In-hospital mortality, data from medical records.[Hospital discharge]
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Short term (in-hospital) complications of venous thrombosis, data from medical records.[Hospital discharge]
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PICU length of stay, data from medical records.[PICU discharge]
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Time on mechanical ventilation, data from medical records.[PICU discharge]
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Source(s) of Monetary Support
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Astrid Lindgren Children´s Hospital (Karolinska University Hospital)
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Ethics review
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Status: Approved
Approval date:
Contact:
Central ethical review board
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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