Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12615000441516
Ethics application status
Approved
Date submitted
16/04/2015
Date registered
7/05/2015
Date last updated
7/05/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
What is the frequency of non-central venous catheter-related venous thrombosis in paediatric intensive care patients?
Scientific title
Frequency of and risk factors for non-central venous catheter-related venous thrombosis in paediatric intensive care patients.
Secondary ID [1] 286232 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous thrombosis in children 294279 0
Condition category
Condition code
Anaesthesiology 294600 294600 0 0
Other anaesthesiology
Blood 294601 294601 0 0
Clotting disorders
Cardiovascular 294602 294602 0 0
Diseases of the vasculature and circulation including the lymphatic system

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 non-central venous catheter-related venous thrombosis in paediatric intensive care patients at Astrid Lindgrens Children´s Hospital.
All paediatric intensive care patients at Astrid Lindgrens Children´s Hospital will be included in the study.

Blood sampling for coagulation tests will be obtained at PICU admission and discharge. Patients will be followed for clinical signs of non-CVC-related venous thrombosis during the time in PICU. Ultrasonography will be used to detect asymptomatic thrombosis at the time of PICU discharge.

Patients will be followed until hospital discharge. Patients that develop non-CVC-related thrombosis will be followed until the end of treatment.
Intervention code [1] 291249 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294372 0
Frequency of non-central venous catheter-related venous thrombosis in PICU assesed by ultrasonography.
Timepoint [1] 294372 0
Duration of PICU stay
Secondary outcome [1] 313124 0
PICU length of stay, data from medical records.
Timepoint [1] 313124 0
PICU discharge
Secondary outcome [2] 313125 0
Hospital length of stay, data from medical records.
Timepoint [2] 313125 0
Hospital discharge
Secondary outcome [3] 313126 0
Time on mechanical ventilation, data from medical records.
Timepoint [3] 313126 0
PICU discharge
Secondary outcome [4] 313127 0
In-hospital mortality, data from medical records.
Timepoint [4] 313127 0
Hospital discharge
Secondary outcome [5] 314442 0
Short term (In-hospital) complications to venous thrombosis, data from medical records.
Timepoint [5] 314442 0
Hospital discharge

Eligibility
Key inclusion criteria
PICU patients
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- No informed consent.
- Death is deemed imminent and inevitable.

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 non-CVC-related venous thrombosis. Multivariate analysis will be used to identify risk factors for venous thrombosis.
There are no previous data on the frequency of non-CVC-related venous thrombosis in PICU patients. The number of participants was chosen based on the expected number of patients meeting inclusion criteria during 12 months in the PICU, Astrid Lindgren´s Children Hospital.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/04/2015
Actual
20/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment outside Australia
Country [1] 6682 0
Sweden
State/province [1] 6682 0

Funding & Sponsors
Funding source category [1] 290793 0
Hospital
Name [1] 290793 0
Astrid Lindgrens Children´s Hospital (Karolinska University Hospital)
Country [1] 290793 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] 289475 0
None
Name [1] 289475 0
Address [1] 289475 0
Country [1] 289475 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292690 0
Central ethics review board
Ethics committee address [1] 292690 0
FE 289
S-171 77 STOCKHOLM
Ethics committee country [1] 292690 0
Sweden
Date submitted for ethics approval [1] 292690 0
Approval date [1] 292690 0
20/03/2015
Ethics approval number [1] 292690 0

Summary
Brief summary
The insertion of a central venous catheter is considered to be the greatest risk factor for venous thrombosis in children. However, the frequency of non-central venous catheter-related venous thrombosis in pediatric intensive care patients has not previously been described. We aim to investigate the frequency of non-central venous catheter-related venous thrombosis in pediatric intensive care patients, and describe associated risk factors and short term complications.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55198 0
Dr Andreas Andersson
Address 55198 0
Department of Paediatric Anaesthesia and Intensive Care
Astrid Lindgrens Children´s Hospital
S-17176 Stockholm
Country 55198 0
Sweden
Phone 55198 0
+46704997886
Fax 55198 0
Email 55198 0
[email protected]
Contact person for public queries
Name 55199 0
Andreas Andersson
Address 55199 0
Department of Paediatric Anaesthesia and Intensive Care
Astrid Lindgrens Children´s Hospital
S-17176 Stockholm
Country 55199 0
Sweden
Phone 55199 0
+46704997886
Fax 55199 0
Email 55199 0
[email protected]
Contact person for scientific queries
Name 55200 0
Andreas Andersson
Address 55200 0
Department of Paediatric Anaesthesia and Intensive Care
Astrid Lindgrens Children´s Hospital
S-17176 Stockholm
Country 55200 0
Sweden
Phone 55200 0
+46704997886
Fax 55200 0
Email 55200 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
SourceTitleYear of PublicationDOI
EmbaseIncidence of venous thromboembolic events not related to vascular catheters in a prospective cohort of critically ill children.2022https://dx.doi.org/10.1007/s00431-022-04487-8
N.B. These documents automatically identified may not have been verified by the study sponsor.