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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
21/03/2019
Date data sharing statement initially provided
21/03/2019
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
Scientific title
Thrombotic complications to paediatric midline catheters
Secondary ID [1] 297109 0
None
Universal Trial Number (UTN)
U1111-1226-8955
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Catheter-related venous thrombosis 311124 0
Catheter-related bloodstream infection 311125 0
Local infection 311126 0
Catheter dislodgement 311128 0
Tissue infiltration 311129 0
Mechanical complications 311130 0
Condition category
Condition code
Anaesthesiology 309759 309759 0 0
Other anaesthesiology
Blood 310189 310189 0 0
Clotting disorders
Infection 310190 310190 0 0
Other infectious diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.






Intervention code [1] 313377 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318715 0
Frequency of midline-related venous thrombosis assessed by ultrasonography
Timepoint [1] 318715 0
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.
Secondary outcome [1] 365808 0
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.
Timepoint [1] 365808 0
Assessed 48 hours after midline removal.
Secondary outcome [2] 366267 0
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.
Timepoint [2] 366267 0
Daily assessments until the catheter is removed.
Secondary outcome [3] 366698 0
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.
Timepoint [3] 366698 0
This will be assessed at the time of catheter removal.

Eligibility
Key inclusion criteria
All children receiving midline catheters at Astrid Lindgren Children´s hospital.
Minimum age
0 Days
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous venous thrombosis in the cannulated vein

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21208 0
Sweden
State/province [1] 21208 0
Stockholm

Funding & Sponsors
Funding source category [1] 301674 0
Hospital
Name [1] 301674 0
Department of Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital
Address [1] 301674 0
Department of Paediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
S3:03 Norrbacka
S-17176 Stockholm
Sweden
Country [1] 301674 0
Sweden
Primary sponsor type
Hospital
Name
Department of Paediatric Perioperative Medicine and Intensive Care, Karolinska University Hospital
Address
Department of Paediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
S3:03 Norrbacka
S-17176 Stockholm
Sweden
Country
Sweden
Secondary sponsor category [1] 301391 0
None
Name [1] 301391 0
Address [1] 301391 0
Country [1] 301391 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302393 0
Central ethics review board of Stockholm, Sweden
Ethics committee address [1] 302393 0
Etikprövningsmyndigheten
FE 111 20
838 82 Frösön
Sweden
Ethics committee country [1] 302393 0
Sweden
Date submitted for ethics approval [1] 302393 0
20/11/2018
Approval date [1] 302393 0
07/02/2019
Ethics approval number [1] 302393 0
2019-00781

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90082 0
Dr Andreas Andersson
Address 90082 0
Department of Paediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
s3:03
Norrbacka
171 76 Stockholm
Sweden
Country 90082 0
Sweden
Phone 90082 0
+46704997886
Fax 90082 0
Email 90082 0
andreas.andersson@sll.se
Contact person for public queries
Name 90083 0
Dr Andreas Andersson
Address 90083 0
Department of Paediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
s3:03
Norrbacka
171 76 Stockholm
Sweden
Country 90083 0
Sweden
Phone 90083 0
+46704997886
Fax 90083 0
Email 90083 0
andreas.andersson@sll.se
Contact person for scientific queries
Name 90084 0
Dr Andreas Andersson
Address 90084 0
Department of Paediatric Perioperative Medicine and Intensive Care
Karolinska University Hospital
s3:03
Norrbacka
171 76 Stockholm
Sweden
Country 90084 0
Sweden
Phone 90084 0
+46704997886
Fax 90084 0
Email 90084 0
andreas.andersson@sll.se

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results