IgG Dependent Monocyte Activation in Proximal Venous Thromboembolism

Completed

• Conditions: Venous Thromboembolism; Pulmonary Embolism
• Interventions: Biological: Blood sampling

• 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

Arm && Interventions

Group	Intervention	Description
Women with proximal VTE	Blood sampling	Patients will correspond to cases of proximal venous thromboembolism. They will be recruited during consultations conducted for the chronic management of a history of proximal venous thromboembolism or thrombophilia following a recent history of proximal venous thromboembolism. Venous thromboembolism, outside of acute phase episodes, has good symptom stability over time; no difference is to be expected between patients with a chronic history of proximal venous thromboembolism and new patients coming in for a checkup. Note that these patients may or may not have a history of placental vascular disease. Intervention: Blood sampling
Women with >1 healthy pregnancy	Blood sampling	This populations is composed of healthy, female, adult volunteers (\<50 years in age) that have had at least 1 healthy pregnancy. Intervention: Blood sampling

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
History of pulmonary embolism? yes/no	Day (0)
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)
The presence / absence of antiphospholipid antibodies: lupus anticoagulant antibodies	Day (0)
Blood D-dimers (ng/mL)	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)

Trial Locations

Locations (2)

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

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