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

Venous Thrombosis Clinical Trial

— TACT  

Official title:

Hypercoagulable Phenotype by Thrombinography (in Presence of C Protein Dynamic Inhibitory System): Marker of Venous Thrombosis Risk in Systemic Lupus and Antiphospholipid Syndrome? Case-control Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892565
• Other study ID #: PHRC 2005/TACT-LECOMPTE/NK
• Status: Completed
• Phase: N/A
• First received: September 2, 2016
• Last updated: September 8, 2016
• Start date: September 2005
• Est. completion date: December 2009

Study information

• Verified date: September 2016
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Interventional

Clinical Trial 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Antiphospholipid Syndrome
• Thrombophilia
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• Blood sample

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thrombin potential measured with thrombinography		baseline	No
Primary	Measurement of IC50-APC (concentration of APC diminishing 50% thrombin potential at APC concentration = 0)		baseline	No