Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)

Descriptive Information
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
Brief Summary	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.
Detailed Description
Study Phase	N/A
Study Type ^†	Observational
Study Design ^†	Observational Model: Case-Only, Time Perspective: Prospective
Primary Outcome Measure ^†	Description of the coagulation parameters
Secondary Outcome Measure ^†
Condition ^†	Acute Lymphoblastic Leukemia
Intervention ^†
Study Arms / Comparison Groups	treatment every 6th week during 6 months treatment every 2nd week during 6 months
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status ^†
Estimated Enrollment ^†	250
Start Date ^†	March 2010
Completion Date	December 2016
Primary Completion Date	December 2010
Eligibility Criteria ^†	Inclusion Criteria: Childhood ALL, eligible to receive standard risk or intermediate risk therapy as described in the protocol, written informed consent has been obtained Exclusion Criteria: No allergic reactions to PEG-asparaginase
Gender	Both
Ages	1 Year - 18 Years
Accepts Healthy Volunteers	No
Contacts ^††	Birgitte K Albertsen, M.D., +45 89495566, biralber@rm.dk , ,
Location Countries ^†	Denmark,
Administrative Information
NCT ID ^†	NCT01094392
Organization ID	Hemostasis-NOPHO
Secondary IDs ^††
Responsible Party	Ph.D. M.D. Birgitte Klug Albertsen, Aarhus University Hospital
Study Sponsor ^†	Aarhus University Hospital
Collaborators ^††
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

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.