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Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by Birgitte Klug Albertsen, Aarhus University Hospital
Information provided by (Responsible Party):
Birgitte Klug Albertsen, Aarhus University Hospital Identifier:
First received: March 17, 2010
Last updated: March 3, 2016
Last verified: March 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.

Acute Lymphoblastic Leukemia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Influence on Hemostasis During Prolonged Asparaginase Treatment in Childhood and Adolescent ALL

Resource links provided by NLM:

Further study details as provided by Birgitte Klug Albertsen, Aarhus University Hospital:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 250
Study Start Date: March 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
treatment every 6th week during 6 months
treatment every 2nd week during 6 months


Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Children and young adults (age 1-17.9 years) newly diagnosed with ALL in the Nordic Countries and treated according to the Nordic ALL-protocol NOPHO ALL-2008.

Written informed consent has been obtained


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01094392

Contact: Birgitte K Albertsen, M.D. +45 89495566 ext 6732

Aalborg Hospital Recruiting
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   
Department of Pediatrics, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Birgitte Lausen, M.D.    +45 35458177   
University Hospital in Odense Recruiting
Odense, Denmark, 5000
Contact: Peder S Wehner, M.D.         
Sponsors and Collaborators
Aarhus University Hospital
Principal Investigator: Birgitte K Albertsen, Ph.D. M.D. Department of Pediatrics, Skejby Hospital, Aarhus, Denmark
  More Information

Responsible Party: Birgitte Klug Albertsen, MD, PhD, Aarhus University Hospital Identifier: NCT01094392     History of Changes
Other Study ID Numbers: Hemostasis-NOPHO
Study First Received: March 17, 2010
Last Updated: March 3, 2016

Keywords provided by Birgitte Klug Albertsen, Aarhus University Hospital:
prolonged treatment
Central venous line

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents processed this record on May 25, 2017