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

• Conditions: Thromboembolism; Acute Lymphoblastic Leukemia

• Registration Number: NCT00982514
• Lead Sponsor: Oslo University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-22
• Study First Submitted QC: 2009-09-22
• Study First Posted: 2009-09-23
• Status Verified: 2012-09
• Last Update Submitted: 2012-09-11
• Last Update Posted: 2012-09-12
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical evident thrombosis	33 weeks
Asymptomatic central line-associated thrombosis	33 weeks

Secondary Outcome Measures

Name	Time	Method
Positive blood culture	33 weeks

Trial Locations

Locations (1)

Rikshospitalet, Dep of Pediatrics; 🇳🇴 Oslo, Norway