Hypercoagulable Phenotype by Thrombinography (in Presence of C Protein Dynamic Inhibitory System) (TACT)

Central Hospital, Nancy, France

Status: Completed

Conditions: Venous Thrombosis

Treatments: Other: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT02892565

PHRC 2005/TACT-LECOMPTE/NK

Details and patient eligibility

About

The purpose is to determine the hypercoagulable phenotype by thrombinography associated to an increased risk of symptomatic and objectively confirmed first venous thrombotic event. This is a case-control study in a population with patients having systemic lupus erythematosus (SLE) and/or antiphospholipid antibodies (APL).

Secondary purposes are:

1. To determine the frequency of hypercoagulable phenotype in study population;
2. To analyze the sensibility: consequences of variation of hypercoagulable phenotype threshold on the importance of risk;
3. To identify (genetic and not) factors for hypercoagulable phenotype and their frequency in different groups.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Cases :

• Patients with SLE and/or APL and first documented deep vein thrombosis episode (minimum 6 months, maximum 6 years)
• Any weight and height
• Absence of current anticoagulant treatment but possibility of platelet function inhibitory treatment; actual guidelines suggest long-term anticoagulant treatment in patients with first episode of venous thrombosis and having APL; however, these patients can be studied if they are in one of these circumstances: 1/ "inconvenient" stop by patient, 2/ aspirin decided by doctor after prolonged treatment

Controls:

• Patients with SLE and/or APL without thrombosis (venous or arterial)
• Any weight and height
• Possibility of platelet function inhibitory treatment (primary prophylaxis of arterial manifestations)

Exclusion criteria

Cases and Controls :

• Pregnancy
• Refusal of consent
• Difficulty of follow-up (not sufficient motivation)

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Cases

Experimental group

Description:

Patients with SLE and/or APL and first vein thrombosis episode

Treatment:

Other: Blood sample

Controls

Other group

Description:

age-matched; Patients with SLE and/or APL

Treatment:

Other: Blood sample