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

NCT02892565 | Completed

• 1 other identifier: PHRC 2005/TACT-LECOMPTE/NK
• Study Type: interventional
• Target: 122
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Venous Thrombosis

Keywords

systemic lupus erythematosus; antiphospholipid syndrome; antiphospholipid antibodies

Outcome Measures

Primary Outcomes (2)

• Thrombin potential measured with thrombinography

  baseline

• Measurement of IC50-APC (concentration of APC diminishing 50% thrombin potential at APC concentration = 0)

  baseline

Study Arms (2)

Cases

EXPERIMENTAL

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

Other: Blood sample

Controls

OTHER

age-matched; Patients with SLE and/or APL

Other: Blood sample

Interventions

Blood sample OTHER

Cases; Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Cases and Controls :
• Pregnancy
• Refusal of consent
• Difficulty of follow-up (not sufficient motivation)

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

MeSH Terms

Conditions

Venous Thrombosis; Lupus Erythematosus, Systemic; Antiphospholipid Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2016
• First Posted: September 8, 2016
• Study Start: September 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: September 9, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share