Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01094392

Enrollment

Registered

2010-03-29

Start date

2010-03-31

Completion date

2018-10-10

Last updated

2021-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Lymphoblastic Leukemia

Keywords

ALL, PEG-asparaginase, prolonged treatment, Thrombosis, Central venous line, Echocardiography

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Description of the coagulation parameters	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.

Countries

Denmark

Outcome results