ThromboembolismNCT00982514
Thromboembolic Complications Related to Asparaginase in Children With Acute Lymphoblastic Leukemia (ALL) Treated According to NOPHO ALL 2008
An observational study of Thromboembolism and Acute Lymphoblastic Leukemia, run by Oslo University Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 1 year to 16 years
- Conditions the study is for
- Thromboembolism, Acute Lymphoblastic Leukemia
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2009to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: Oslo University Hospital, Department of Pediatrics
Who may be able to join
- Acute lymphoblastic leukaemia,
- Age 1 year to 16 years old,
- Central line,
- Protocol NOPHO ALL 2008.
Who cannot join
- Refusal of participation,
- Treated according to protocol other than NOPHO ALL 2008.
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Rikshospitalet, Dep of Pediatrics
Oslo, Oslo, 0027
Ellen Ruud, MD PhD
About this study
Official title: Thromboembolic Complications Related to Asparaginase in Children With ALL Treated According to NOPHO ALL 2008
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.
- Conditions
- Thromboembolism, Acute Lymphoblastic Leukemia
- Keywords
- Asparaginase, thrombosis, ALL, central line
- Medical subject headings
- Thromboembolism, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Standard dose asparaginase | Children who according to the protocol NOPHO ALL 2008 receive standard dose asparaginase | |
| Reduced dose asparaginase | Children who receive reduced dose asparaginase according to NOPHO ALL 2008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evident thrombosis
Measured: 33 weeks
Asymptomatic central line-associated thrombosis
Measured: 33 weeks
Secondary outcomes (1)
Positive blood culture
Measured: 33 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ellen Ruud, MD PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982514
- Sponsor's protocol ID
- ASP NOPHO 2008
- Status last verified
- Sep 2012
- First submitted
- 22 Sep 2009
- Last updated
- 12 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboembolic Complications Related to Asparaginase in Children With ALL Treated According to NOPHO ALL 2008
- ClinicalTrials.gov ID
- NCT00982514
- Acronym / sponsor ID
- ASP NOPHO 2008
- Conditions
- Thromboembolism, Acute Lymphoblastic Leukemia
- Keywords
- Asparaginase, thrombosis, ALL, central line
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 23 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard dose asparaginase | – | –Children who according to the protocol NOPHO ALL 2008 receive standard dose asparaginase |
| Reduced dose asparaginase | – | –Children who receive reduced dose asparaginase according to NOPHO ALL 2008 |
Who may qualify
- Ages
- 1 year to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Oslo University Hospital, Department of Pediatrics
Key inclusion criteria (4 listed)
- Acute lymphoblastic leukaemia,
- Age 1 year to 16 years old,
- Central line,
- Protocol NOPHO ALL 2008.
Key exclusion criteria (2 listed)
- Refusal of participation,
- Treated according to protocol other than NOPHO ALL 2008.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical evident thrombosis
Time frame: 33 weeks
Asymptomatic central line-associated thrombosis
Time frame: 33 weeks
1 secondary outcome
Positive blood culture
Time frame: 33 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2012.
- The home page for NOPHO who is responsible for the ALL treatment protocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Ruud, MD PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thromboembolism and Acute Lymphoblastic Leukemia, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ellen Ruud, MD PhD (+47 23074560, ellen.ruud@rikshospitalet.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evident thrombosis (time frame: 33 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2012.