IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism

Completed

• Conditions: Venous Thromboembolism; Pulmonary Embolism

• Registration Number: NCT02713581
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The primary objective of this study is to search for, in vitro, elements associated with IgG-dependent monocyte activation (signaling pathway activation, expression of pro-coagulant and pro-inflammatory factors) and to describe their prevalence in female patients with a history of proximal venous thromboembolism (proximal deep vein thrombosis or pulmonary embolism) compared to control women.

Detailed Description

The secondary objectives of this study include to compare the IgG-dependent monocyte activation profiles as a function of laboratory thrombophilia parameters. Essentially: Is IgG-dependent cell activation associated with the presence of anti-phospholipid antibodies (or their subtypes?), or do these profiles indicate something beyond the nosology of anti-phospholipid syndrome?

Study Timeline

• Study First Submitted: 2016-03-15
• Study First Submitted QC: 2016-03-17
• Study First Posted: 2016-03-18
• Study Start: 2017-01-03
• Primary Completion: 2019-01-03
• Status Verified: 2020-06
• Study Completion: 2020-06-23
• Last Update Submitted: 2020-06-29
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The presence/absence of an activation profile	Day (0)	The following will be taken into account: Six signaling pathways (Protein kinase B, extracellular-signal-regulated kinases, Signal transducer and activator of transcription 5, P38 mitogen-activated protein kinases, Mechanistic Target Of Rapamycin, nuclear factor kappa-light-chain-enhancer of activated B cells), increases in the expression of tissue factor, and 5 pro-inflammatory factors (Intercellular Adhesion Molecule, tumor necrosis factor alpha, interferon gamma, Interleukin-1 beta, Interleukin 8). A pathway will be considered as "activated" or an expression profile as "increased" when the observed value is superior to the 95% confidence interval determined using healthy volunteer values. A patient is considered as having an activation profile if at least one of the above pathways or expressions is considered as activated / increased.

Secondary Outcome Measures

Name	Time	Method
The presence / absence of a constitutional biological thrombophilia	Day (0)	The presence / absence of a constitutional biological thrombophilia (mutation of the Leiden V factor and the prothrombin gene, deficiency in physiological coagulation inhibitors)
Fibrin monomer (blood; mg/ L)	Day (0)
History of proximal deep vein thrombosis? yes/no	Day (0)
History of placental vascular pathology? yes/no	Day (0)
Blood D-dimers (ng/mL)	Day (0)
History of pulmonary embolism? yes/no	Day (0)
The presence / absence of antiphospholipid antibodies: anti-beta2-glycoprotein 1 antibodies	Day (0)
The presence / absence of antiphospholipid antibodies: anti-cardiolipid antibodies	Day (0)
The presence / absence of antiphospholipid antibodies: lupus anticoagulant antibodies	Day (0)

Trial Locations

Locations (2)

CHRU de Montpellier - Hôpital Saint-Eloi; 🇫🇷 Montpellier cedex 5, France

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France