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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02892565
Other study ID # PHRC 2005/TACT-LECOMPTE/NK
Secondary ID
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


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
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