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Influence on Hemostasis During Prolonged Asparaginase Treatment in Childhood and Adolescent ALL


N/A
1 Year
18 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia

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Trial Information

Influence on Hemostasis During Prolonged Asparaginase Treatment in Childhood and Adolescent ALL


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Description of the coagulation parameters

Outcome Description:

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.

Outcome Time Frame:

December 2016

Safety Issue:

Yes

Principal Investigator

Birgitte K Albertsen, Ph.D. M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Pediatrics, Skejby Hospital, Aarhus, Denmark

Authority:

Denmark: Ethics Committee

Study ID:

Hemostasis-NOPHO

NCT ID:

NCT01094392

Start Date:

March 2010

Completion Date:

December 2016

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • ALL
  • PEG-asparaginase
  • prolonged treatment
  • Thrombosis
  • Central venous line
  • Echocardiography
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

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