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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12619000472178
Ethics application status
Approved
Date submitted
10/02/2019
Date registered
21/03/2019
Date last updated
23/02/2023
Date data sharing statement initially provided
21/03/2019
Date results information initially provided
24/08/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
An investigation of blood clots and other complications related to longer peripheral intravenous catheters in children
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Scientific title
Thrombotic complications to paediatric midline catheters
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Secondary ID [1]
297109
0
None
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Universal Trial Number (UTN)
U1111-1226-8955
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Catheter-related venous thrombosis
311124
0
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Catheter-related bloodstream infection
311125
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Local infection
311126
0
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Catheter dislodgement
311128
0
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Tissue infiltration
311129
0
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Mechanical complications
311130
0
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Condition category
Condition code
Anaesthesiology
309759
309759
0
0
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Other anaesthesiology
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Blood
310189
310189
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0
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Clotting disorders
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Infection
310190
310190
0
0
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Other infectious diseases
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
The primary outcome of the study is the frequency of midline catheter-related venous thrombosis in children receiving midline catheters at Astrid Lindgrens Children´s Hospital.
100 children receiving midline catheters at Astrid Lindgrens Children´s Hospital will be included in the study. The objectives of the study is primary to characterize the frequency of midline catheter-related venous thrombosis but also other possible complications in children receiving midline catheters at Astrid Lindgren Children´s Hospital.
Patients will be followed for clinical signs of midline-related venous thrombosis as long as the catheter is in place. Ultrasonography will be used to detect asymptomatic venous thrombosis at the time of midline catheter removal.
Patients that develop midline-related venous thrombosis will be followed until the end of treatment.
Patients will be followed for other midline-related complications, such as infection, thrombophlebitis and mechanical complications.
Life-span of midline catheter and the need for additional venous access to complete therapy will also be recorded.
The total duration of observation per participant will be approximately 1-2 weeks.
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Intervention code [1]
313377
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Early Detection / Screening
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
318715
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Frequency of midline-related venous thrombosis assessed by ultrasonography
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Assessment method [1]
318715
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Timepoint [1]
318715
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Duration of midline catheter.
Ultrasonography will be performed:
1. If clinical signs of venous thrombosis appear during the dwell-time of the midline catheter.
2. At the time of midline catheter removal to screen for asymptomatic venous thrombosis.
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Secondary outcome [1]
365808
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Midline-related bloodstream infection. Defined as a laboratory-confirmed bloodstream infection in a patient who had a midline within the 48 hour period before the development of the bloodstream infection, and that is not related to an infection at another site.
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Assessment method [1]
365808
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Timepoint [1]
365808
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Assessed 48 hours after midline removal.
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Secondary outcome [2]
366267
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Removal of midline catheter due to:
1. Mechanical complication to midline catheter (occlusion, dislodgement, extravasation)
2..Thrombophlebitis.
This will be assessed by the treating physician in charge of the patient.
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Assessment method [2]
366267
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Timepoint [2]
366267
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Daily assessments until the catheter is removed.
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Secondary outcome [3]
366698
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The need for additional venous access to complete intended therapy. Defined as a need to insert an additional venous access to complete the intended therapy due to premature dysfunction of the midline catheter.
The need for additional venous access will be decided by the treating physician in charge of the patient.
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Assessment method [3]
366698
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Timepoint [3]
366698
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This will be assessed at the time of catheter removal.
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Eligibility
Key inclusion criteria
All children receiving midline catheters at Astrid Lindgren Children´s hospital.
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Minimum age
0
Days
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Previous venous thrombosis in the cannulated vein
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Data will be tested for normality using D’Agostino & Pearson omnibus normality test. Parametric or non-parametric statistics will be used as appropriate to investigate differences between patients with and without midline-related deep venous thrombosis. Logistic regression including univariate and multivariate analysis will be used to identify risk factors for developing midline-related deep venous thrombosis.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
6/05/2019
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Actual
13/05/2019
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Date of last participant enrolment
Anticipated
31/12/2020
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Actual
23/06/2021
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Date of last data collection
Anticipated
28/02/2021
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Actual
2/07/2021
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Sample size
Target
100
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Accrual to date
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Final
100
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Recruitment outside Australia
Country [1]
21208
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Sweden
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State/province [1]
21208
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Stockholm
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Funding & Sponsors
Funding source category [1]
301674
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Hospital
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Name [1]
301674
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Department of Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital
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Address [1]
301674
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Department of Paediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
S3:03 Norrbacka
S-17176 Stockholm
Sweden
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Country [1]
301674
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Sweden
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Primary sponsor type
Hospital
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Name
Department of Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital
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Address
Department of Paediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
S3:03 Norrbacka
S-17176 Stockholm
Sweden
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Country
Sweden
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Secondary sponsor category [1]
301391
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None
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Name [1]
301391
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Address [1]
301391
0
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Country [1]
301391
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302393
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Central ethics review board of Stockholm, Sweden
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Ethics committee address [1]
302393
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Etikprövningsmyndigheten
FE 111 20
838 82 Frösön
Sweden
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Ethics committee country [1]
302393
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Sweden
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Date submitted for ethics approval [1]
302393
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20/11/2018
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Approval date [1]
302393
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07/02/2019
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Ethics approval number [1]
302393
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2019-00781
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Summary
Brief summary
Midline catheters are being used more frequently in both the adult and paediatric population. However, data is sparse regarding midline-related complications in the paediatric setting. Our aim is to determine the frequency of venous thrombosis related to paediatric midline catheters. We will also investigate the frequency of other midline-related complications, and the average dwell-time for paediatric midline catheters. The need for additional venous access to complete the intended therapy will also be registered.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
90082
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Dr Andreas Andersson
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Address
90082
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Department of Paediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
s3:03
Norrbacka
171 76 Stockholm
Sweden
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Country
90082
0
Sweden
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Phone
90082
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+46704997886
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Fax
90082
0
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Email
90082
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[email protected]
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Contact person for public queries
Name
90083
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Dr Andreas Andersson
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Address
90083
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Department of Paediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
s3:03
Norrbacka
171 76 Stockholm
Sweden
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Country
90083
0
Sweden
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Phone
90083
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+46704997886
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Fax
90083
0
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Email
90083
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[email protected]
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Contact person for scientific queries
Name
90084
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Dr Andreas Andersson
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Address
90084
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Department of Paediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
s3:03
Norrbacka
171 76 Stockholm
Sweden
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Country
90084
0
Sweden
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Phone
90084
0
+46704997886
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Fax
90084
0
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Email
90084
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Complications of Pediatric Midline Catheters: A Pr...
[
More Details
]
Documents added automatically
No additional documents have been identified.
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