MedDataX Logo

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

NCT ID: NCT00982514

Last Updated: 2012-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thromboembolism Acute Lymphoblastic Leukemia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Asparaginase thrombosis ALL central line

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard dose asparaginase

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

No interventions assigned to this group

Reduced dose asparaginase

Children who receive reduced dose asparaginase according to NOPHO ALL 2008

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ellen Ruud, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rikshospitalet, Dep of Pediatrics

Oslo, Oslo County, Norway

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Norway

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ellen Ruud, MD PhD

Role: CONTACT

Phone: +47 23074560

Email: [email protected]

Tonje Reiersen, MD

Role: CONTACT

Phone: +47 23070000

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ASP NOPHO 2008

Identifier Type: -

Identifier Source: org_study_id