Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)

Completed

• Conditions: Acute Lymphoblastic Leukemia

• Registration Number: NCT01094392
• Lead Sponsor: Aarhus University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-03-26
• Study First Posted: 2010-03-29
• Status Verified: 2016-03
• Primary Completion: 2018-10-10
• Study Completion: 2018-10-10
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Department of Pediatrics, Skejby Hospital; 🇩🇰 Aarhus, Denmark

Aalborg Hospital; 🇩🇰 Aalborg, Denmark

Department of Pediatrics, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

University Hospital in Odense; 🇩🇰 Odense, Denmark