Role of the Microparticles and of Tissue Factor in the Pro-thrombotic Phenotype and the Thromboembolic Complications During the Acute Lymphoblastic Leukemia in Children.

NCT ID: NCT02862652

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2017-03-21

Brief Summary

Acute lymphoblastic leukemia is the most common malignancy of the child. Current therapeutic strategies allow healing of over 80% of children. However these treatments are associated with toxicity, with a mortality of 1-2%. The most frequent complications, occuring during treatment initiation, are the thromboembolic complications.

The most commonly accepted explanation is that of an anti-thrombin depletion by chemotherapy used in the treatment, L-asparaginase. But the anti-thrombin supplementation showed no efficacy in the prevention of these thromboembolic complications. Therefore most authors consider that a multifactorial mechanism is behind these events, involving both treatment and malignant cells. The interaction of these two factors participate in the damage of the vascular endothelium.

The microparticles are membrane fragments derived from budding from the membrane of activated cells or apoptosis. Their thrombogenic role is linked to the expression of coagulation activators such as tissue factor. It is also associated with their role in the modulation of signaling pathways involved in the invasiveness and angiogenesis in endothelial cells.

In acute lymphoblastic leukemia, the presence and role of microparticles have not been studied. Our hypothesis is that of production of microparticles upon lysis of blasts then upon activation of endothelial cells induced by the induction therapy, participating in a procoagulant phenotype.

Detailed Description

The aims of this study are

• quantify the microparticles in children receiving induction therapy for Acute lymphoblastic leukemia at diagnosis and during treatment
• study the origin of these particles and the expression and activity of the tissue factor on their surface, at diagnosis and during treatment

Conditions

Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

children with acute lymphoblastic leukemia

Group Type: EXPERIMENTAL

Blood sample

Intervention Type: OTHER

Blood sample to quantify microparticles and to study expression and activity of the tissue factor on their surface

Interventions

Blood sample

Blood sample to quantify microparticles and to study expression and activity of the tissue factor on their surface

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• children with acute lymphoblastic leukemia
• children and their parents consenting to participate to the study
• children enrolled in the national healthcare insurance program

• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu de Reims

Reims, , France

Countries

France

References

Pluchart C, Barbe C, Poitevin G, Audonnet S, Nguyen P. A pilot study of procoagulant platelet extracellular vesicles and P-selectin increase during induction treatment in acute lymphoblastic leukaemia paediatric patients: two new biomarkers of thrombogenic risk? J Thromb Thrombolysis. 2021 Apr;51(3):711-719. doi: 10.1007/s11239-020-02346-7. Epub 2020 Nov 28.

Reference Type: BACKGROUND

PMID: 33247807 (View on PubMed)

Other Identifiers

PA13047

Identifier Type: -

Identifier Source: org_study_id