Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(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.
Acute Lymphoblastic Leukemia
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Influence on Hemostasis During Prolonged Asparaginase Treatment in Childhood and Adolescent ALL|
- Description of the coagulation parameters [ Time Frame: December 2016 ] [ Designated as safety issue: Yes ]The study is a prospective and descriptive study. Levels of coagulation parameters will be analyzed using Two Sample T-Test and the levels of asparaginase in serum will be analyzed by Chi2 test.
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
|treatment every 6th week during 6 months|
|treatment every 2nd week during 6 months|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01094392
|Contact: Birgitte K Albertsen, M.D.||+45 89495566 ext email@example.com|
|Aalborg, Denmark, 9000|
|Contact: Jon Helgestad, M.D.|
|Department of Pediatrics, Skejby Hospital||Recruiting|
|Aarhus, Denmark, 8200|
|Contact: Birgitte K Albertsen, M.D. +45 89495566 ext 6732 firstname.lastname@example.org|
|Department of Pediatrics, Rigshospitalet||Recruiting|
|Copenhagen, Denmark, 2100|
|Contact: Birgitte Lausen, M.D. +45 35458177 Birgitte.Lausen@rh.regionh.dk|
|University Hospital in Odense||Recruiting|
|Odense, Denmark, 5000|
|Contact: Peder S Wehner, M.D.|
|Principal Investigator:||Birgitte K Albertsen, Ph.D. M.D.||Department of Pediatrics, Skejby Hospital, Aarhus, Denmark|