Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)

NCT01094392 | Completed

• 1 other identifier: Hemostasis-NOPHO
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 4

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.

Conditions

Acute Lymphoblastic Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

treatment every 6th week during 6 months

treatment every 2nd week during 6 months

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Childhood ALL, eligible to receive standard risk or intermediate risk therapy as described in the protocol, written informed consent has been obtained

You may not qualify if:

• No allergic reactions to PEG-asparaginase

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (4)

Aalborg Hospital

Aalborg, 9000, Denmark

Location

Department of Pediatrics, Skejby Hospital

Aarhus, 8200, Denmark

Location

Department of Pediatrics, Rigshospitalet

Copenhagen, 2100, Denmark

Location

University Hospital in Odense

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Thrombosis

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Birgitte K Albertsen, Ph.D. M.D.

  Department of Pediatrics, Skejby Hospital, Aarhus, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 29, 2010
• Study Start: March 1, 2010
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: January 13, 2021

Record last verified: 2016-03

Locations

DK (4)