Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)
|Brief Title †||Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)|
|Official Title †||Influence on Hemostasis During Prolonged Asparaginase Treatment in Childhood and Adolescent ALL|
Asparaginase is an important drug in the treatment of childhood leukemia. One of the rare but severe side effects to the treatment is thrombosis in or outside the central nervous system.
The aim of this study is to investigate and describe the influence on the coagulation parameters during prolonged treatment with asparaginase.
Hopefully this knowledge will help to foresee the risk of thrombosis and thus making it possible to prevent these.
|Study Type †||Observational|
|Study Design †||Observational Model: Case-Only, Time Perspective: Prospective|
|Primary Outcome Measure †||Description of the coagulation parameters|
|Secondary Outcome Measure †|
|Study Arms / Comparison Groups||
|* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.|
|Recruitment Status †|
|Estimated Enrollment †||250|
|Start Date †||March 2010|
|Completion Date||December 2016|
|Primary Completion Date||December 2010|
|Eligibility Criteria †||
|Ages||1 Year - 18 Years|
|Accepts Healthy Volunteers||No|
|Location Countries †||Denmark,|
|NCT ID †||NCT01094392|
|Secondary IDs ††|
|Responsible Party||Ph.D. M.D. Birgitte Klug Albertsen, Aarhus University Hospital|
|Study Sponsor †||Aarhus University Hospital|
|Investigators †||Principal Investigator: Birgitte K Albertsen, Ph.D. M.D., Department of Pediatrics, Skejby Hospital, Aarhus, Denmark|
|Information Provided By||Aarhus University Hospital|
|Verification Date||March 2010|
|First Received Date †||March 17, 2010|
|Last Updated Date||March 26, 2010|
†† WHO trial registration data element that is required only if it exists.