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NCT00982514 Clinical Trial

Thromboembolic Complications Related to Asparaginase in Children With Acute Lymphoblastic Leukemia (ALL) Treated According to NOPHO ALL 2008

Acute Lymphoblastic Leukemia Clinical Trial

Official title:
Thromboembolic Complications Related to Asparaginase in Children With ALL Treated According to NOPHO ALL 2008

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00982514
Other study ID # ASP NOPHO 2008
Secondary ID
Status Recruiting
Phase N/A
First received September 22, 2009
Last updated September 11, 2012
Start date September 2009
Est. completion date December 2014

Study information
Verified date September 2012
Source Oslo University Hospital
Contact Ellen Ruud, MD PhD
Phone +47 23074560
Email ellen.ruud@rikshospitalet.no
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 16 Years
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Rikshospitalet, Dep of Pediatrics Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical evident thrombosis 33 weeks No
Primary Asymptomatic central line-associated thrombosis 33 weeks No
Secondary Positive blood culture 33 weeks No
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