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Trial registered on ANZCTR


Registration number
ACTRN12624001224516
Ethics application status
Approved
Date submitted
16/09/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigating blood clots and risk factors in children with congenital heart disease undergoing surgery with central lines.
Scientific title
Central venous access device (CVAD) associated thrombosis for neonates and infants with congenital heart disease: a prospective cohort study.
Secondary ID [1] 312963 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Heart Disease
Central Venous access devices (CVAD) associated thrombosis 335137 0
Condition category
Condition code
Cardiovascular 331636 331636 0 0
Other cardiovascular diseases
Blood 331900 331900 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Central Venous Access Device (CVAD) Associated Thrombosis in Neonates and Infants with Congenital Heart Disease

This is an observational study designed to identify the incidence of central venous access device (CVAD)-associated thrombosis in neonates and infants undergoing cardiac surgery for congenital heart disease. The study aims to evaluate the modifiable and non-modifiable risks for the development of CVAD-associated thrombosis.

Procedures/Activities:
1. Ultrasound Monitoring: All CVAD insertions are completed under ultrasound (USS) guidance to monitor for potential thrombosis. Dedicated ultrasound scans will be performed on insertion and day 4 post-CVAD insertion, either with the CVAD still in place or removed. Follow-up ultrasounds may occur at 12 months for infants with diagnosed thrombosis.

2. Imaging: The neck CVAD insertion sites (internal jugular vein, subclavian vein, and brachiocephalic vein) and groin insertion sites (common femoral vein, external iliac vein, and common iliac vein) will be documented using high-frequency duplex ultrasound.

3. Blinded Ultrasound: On day 4 post-insertion, a blinded ultrasound of the CVAD and adjacent vessel will be performed. Results will not be given to the clinical team unless needed for the patient's care. If thrombosis is identified, results will be discussed with parents at discharge, along with appropriate counseling.

4. Thrombosis Resolution Follow-up: For infants with diagnosed CVAD-associated venous thrombosis, follow-up ultrasounds will be scheduled approximately 12 months after the initial CVAD insertion to assess thrombus size, type, and resolution.

Mode of Delivery:
- Face-to-face monitoring and follow-up will occur within Queensland Children’s Hospital (QCH), specifically in the cardiac ward, PICU, and medical imaging departments.
- Ultrasound imaging will be done in the patient’s hospital bed or in the medical imaging department, depending on patient mobility.

Duration:
The intervention (ultrasound monitoring) will be administered at specified intervals during and post-surgery:
- Initial ultrasound on insertion or within 4 days of CVAD insertion.
- Blinded 4 day ultrasound
- Follow-up ultrasound approximately 12 months post-CVAD insertion for patients with thrombosis.

Intervention Providers:
- Paediatric sonographers with expertise in cardiac and vascular ultrasound will perform imaging.
- Anaesthetists will assist with intraoperative ultrasound guidance during CVAD insertion.

Fidelity and Adherence:
Intervention fidelity will be maintained through the use of a standardised ultrasound protocol. All sonographers will complete dedicated worksheets, and images will be reviewed and reported by a radiologist. Safeguards are in place to ensure prompt action if thrombosis is detected.
Intervention code [1] 329496 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339365 0
Incidence of CVAD-associated venous thrombus
Timepoint [1] 339365 0
4 days post CVAD insertion and approximately 12 months post CVAD insertion for infants with positive primary outcomes.
Secondary outcome [1] 439674 0
Incidence of asymptomatic Central Venous Access Device associated venous thrombus
Timepoint [1] 439674 0
4 days post CVAD insertion and approximately 12 months post CVAD insertion for infants with a positive primary outcome.
Secondary outcome [2] 439675 0
Incidence of symptomatic Central Venous Access Device associated venous thrombus
Timepoint [2] 439675 0
4 days post CVAD insertion and approximately 12 months post CVAD insertion for infants with a positive primary outcome.
Secondary outcome [3] 439676 0
Incidence of occlusive thrombus
Timepoint [3] 439676 0
4 days post-CVAD insertion and approximately 12 months post-CVAD insertion for infants with a positive primary outcome.
Secondary outcome [4] 439677 0
Incidence of non-occlusive thrombus
Timepoint [4] 439677 0
4 days post-CVAD insertion and approximately 12 months post-CVAD insertion for infants with a positive primary outcome.
Secondary outcome [5] 439678 0
Incidence of major bleeding
Timepoint [5] 439678 0
During the post-operative hospital stay (up to 12 months post-CVAD insertion, if relevant for infants with positive primary outcomes). This Assessment will be carried out daily as a clinical assessment as long as they are in patients.
Secondary outcome [6] 439679 0
Incidence of Central Venous Access Device-associated bloodstream infection
Timepoint [6] 439679 0
Throughout the post-operative hospital stay (up to 12 months post-CVAD insertion for infants with positive primary outcomes). The frequency of assessment will determined by clinical signs and symptoms
Secondary outcome [7] 439680 0
Incidence of post-operative chylothorax
Timepoint [7] 439680 0
Throughout the post-operative hospital stay (up to 12 months post-CVAD insertion for infants with positive primary outcomes). The Frequency of assesment will be determined by the clinical signs and symptoms. the patients are examined clinically daily.
Secondary outcome [8] 439681 0
Incidence of mortality during the surgical encounter
Timepoint [8] 439681 0
During the post-operative hospital stay. This is done monthly as a continuing departmental audit process.
Secondary outcome [9] 439682 0
Central Venous Access Device - associated thrombosis-related treatments and related costs. This costs will be assessed as a composite outcome.
Timepoint [9] 439682 0
During the post-operative hospital stay and at follow-up (up to 12 months post-CVAD insertion for infants with positive primary outcomes). This will be assessed at the time of hospital discharge and at one year follow up.
Secondary outcome [10] 439683 0
Thrombosis resolution at 12 months
Timepoint [10] 439683 0
Approximately 12 months post central venous access device insertion

Eligibility
Key inclusion criteria
Age: Neonates and infants less than 1 year of age.
Diagnosis: Infants diagnosed with congenital heart disease (CHD).
Surgical Procedure: Undergoing cardiac surgery at Queensland Children’s Hospital, with or without cardiopulmonary bypass.
CVAD Requirement: Surgery necessitates the insertion of a Central Venous Access Device (CVAD), including all types of CVADs such as peripherally inserted central catheters (PICCs).
First or Subsequent CVADs: Includes both the first intra-operative CVAD insertion or any subsequent CVADs required during the same surgical encounter.
Minimum age
0 Days
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-existing CVADs: Neonates and infants with a Central Venous Access Device (CVAD) already in place upon admission from an external site (e.g., neonatal intensive care unit).
Umbilical Catheters: Patients with umbilical catheters inserted prior to or during the surgical procedure.
Current Infectious Disease: Infants with an active or diagnosed infectious disease at the time of admission or surgery.
Non-Cardiac Surgical Cases: Any patient not undergoing surgery related to congenital heart disease or who does not require a CVAD as part of their surgical or post-operative care.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
1. Sample Size Estimation
The estimated number of participants required for this study is based on international data indicating that the incidence of CVAD-associated thrombosis in neonates and infants with congenital heart disease (CHD) undergoing cardiac surgery varies between 11% (symptomatic only) and 61% (including asymptomatic cases). Over a 12-month period, it is anticipated that approximately 270 neonates and infants will undergo 300 cardiac surgical procedures, requiring a total of 310 CVADs. The study aims to capture this population to ensure a sufficient number of cases for statistical analysis of both symptomatic and asymptomatic thrombosis.
2 Statistical Analysis Plan
Data analysis will be conducted using the appropriate measures of spread and locations. Prior to analysis, a rigorous process of data cleaning to check outlying figures, missing, and implausible data against source data will be undertaken. Descriptive statistics will be used to summarise patient characteristics. Parametric or nonparametric techniques appropriate to the distribution of data will be applied. Results of the study will inform the future prophylactic management of thrombosis in children undergoing cardiac surgery in our institution.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
15/05/2023
Date of last participant enrolment
Anticipated
Actual
12/05/2024
Date of last data collection
Anticipated
12/05/2025
Actual
Sample size
Target
270
Accrual to date
Final
131
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27093 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 43167 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 317372 0
Hospital
Name [1] 317372 0
Study Education and Research Trust Account (SERTA) funded by Children's Health Queensland (CHQ)
Country [1] 317372 0
Australia
Primary sponsor type
Hospital
Name
Children's Health Queensland Hospital and Health Service
Address
Country
Australia
Secondary sponsor category [1] 319660 0
None
Name [1] 319660 0
Address [1] 319660 0
Country [1] 319660 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316101 0
Children's Health Queensland Human Research Ethics Committe (CHQ HREC)
Ethics committee address [1] 316101 0
Ethics committee country [1] 316101 0
Australia
Date submitted for ethics approval [1] 316101 0
26/07/2022
Approval date [1] 316101 0
03/08/2022
Ethics approval number [1] 316101 0
HREC/22/QCHQ/84496

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136782 0
A/Prof Prem Venugopal
Address 136782 0
Queensland Children's Hospital 501 Stanley Street, South Brisbane QLD 4101
Country 136782 0
Australia
Phone 136782 0
+61 7 30685775
Fax 136782 0
Email 136782 0
prem.venugopal@health.qld.gov.au
Contact person for public queries
Name 136783 0
Prem Venugopal
Address 136783 0
Queensland Children's Hospital 501 Stanley Street, South Brisbane QLD 4101
Country 136783 0
Australia
Phone 136783 0
+61 7 30685775
Fax 136783 0
Email 136783 0
prem.venugopal@health.qld.gov.au
Contact person for scientific queries
Name 136784 0
Prem Venugopal
Address 136784 0
Queensland Children's Hospital 501 Stanley Street, South Brisbane QLD 4101
Country 136784 0
Australia
Phone 136784 0
+61 7 30685775
Fax 136784 0
Email 136784 0
prem.venugopal@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient privacy.
Cohort data will be available in the form of a publication.


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.