Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01094392|
Recruitment Status : Recruiting
First Posted : March 29, 2010
Last Update Posted : March 4, 2016
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.
|Condition or disease|
|Acute Lymphoblastic Leukemia|
|Study Type :||Observational|
|Estimated Enrollment :||250 participants|
|Official Title:||Influence on Hemostasis During Prolonged Asparaginase Treatment in Childhood and Adolescent ALL|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
|treatment every 6th week during 6 months|
|treatment every 2nd week during 6 months|
- Description of the coagulation parameters [ Time Frame: December 2016 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|