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

University of Oslo (UIO)

Status: Unknown

Conditions: Thromboembolism; Acute Lymphoblastic Leukemia

Study type: Observational

Funder types: Other

Identifiers

NCT00982514

ASP NOPHO 2008

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 2 patient groups

Standard dose asparaginase

Description:

Children who according to the protocol NOPHO ALL 2008 receive standard dose asparaginase

Reduced dose asparaginase

Description:

Children who receive reduced dose asparaginase according to NOPHO ALL 2008