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NCT01094392 Clinical Trial

Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)

Acute Lymphoblastic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01094392
Other study ID # Hemostasis-NOPHO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2010
Est. completion date October 10, 2018

Study information
Verified date March 2016
Source Aarhus University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 65
Est. completion date October 10, 2018
Est. primary completion date October 10, 2018
Accepts healthy volunteers No
Gender All
Age group 1 Year to 18 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Aalborg Hospital Aalborg
Denmark Department of Pediatrics, Skejby Hospital Aarhus
Denmark Department of Pediatrics, Rigshospitalet Copenhagen
Denmark University Hospital in Odense Odense

Sponsors (1)
Lead Sponsor Collaborator
Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Description of the coagulation parameters 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. December 2016
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