NCT00982514UnknownNot Applicable
Thromboembolic Complications Related to Asparaginase in Children With ALL Treated According to NOPHO ALL 2008
Oslo University Hospital1 site in 1 country60 target enrollmentStarted: September 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Clinical evident thrombosis
Study Overview
Brief Summary
The study will examine the prevalence of venous thromboembolism in children with acute lymphoblastic leukaemia treated in accordance with NOPHO ALL-2008. The investigators will prospectively study clinical symptomatic thromboses, asymptomatic central line-associated thromboses, and infections.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 1 Year to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Acute lymphoblastic leukaemia,
- •Age 1 year to 16 years old,
- •Central line,
- •Protocol NOPHO ALL 2008.
Exclusion Criteria
- •Refusal of participation,
- •Treated according to protocol other than NOPHO ALL 2008.
Outcomes
Primary Outcomes
Clinical evident thrombosis
Time Frame: 33 weeks
Asymptomatic central line-associated thrombosis
Time Frame: 33 weeks
Secondary Outcomes
- Positive blood culture(33 weeks)
Investigators
Study Sites (1)
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