Clinical trial · Observational

Hemostasis During Asparaginase Treatment in Acute Lymphoblastic Leukemia(ALL)

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

NCT01094392CI-TRIAL-00049392completedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Acute Lymphoblastic Leukemia	Acute Lymphoblastic Leukemia	ONTOLOGY_EXACT	0.98

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (2)

label
treatment every 6th week during 6 months
label
treatment every 2nd week during 6 months

Primary outcomes (1)

measure
Description of the coagulation parameters
timeFrame
December 2016
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 1 Year
Maximum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Mar 1, 2010
Primary completion: Oct 10, 2018
Completion: Oct 10, 2018
First posted: Mar 29, 2010
Last update posted: Jan 13, 2021
Enrollment: 65 (actual)
Lead sponsor: Aarhus University Hospital OTHER
Keywords: ALL, PEG-asparaginase, prolonged treatment, Thrombosis, Central venous line, Echocardiography

Data updated 22 days agoSource updated Jan 13, 2021source: clinicaltrials

Locations

Locations by country (4)

Country	Sites	Recruiting
Denmark	4	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.