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Completed

NCT Number: NCT02892565

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

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.

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Key information

Conditions

Venous Thrombosis Antiphospholipid Syndrome Autoimmune Diseases Cardiovascular Diseases Connective Tissue Diseases Embolism and Thrombosis Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

blood sample

Other

Primary outcomes

  1. Thrombin potential measured with thrombinography

    Time frame: baseline

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

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study 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

Acronym: TACT

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 8, 2016
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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