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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02892565

Acronym

TACT

Enrollment

122

Registered

2016-09-08

Start date

2005-09-30

Completion date

2009-12-31

Last updated

2016-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thrombosis

Keywords

systemic lupus erythematosus, antiphospholipid syndrome, antiphospholipid antibodies

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. 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.

Interventions

OTHERBlood sample

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame
Thrombin potential measured with thrombinography	baseline
Measurement of IC50-APC (concentration of APC diminishing 50% thrombin potential at APC concentration = 0)	baseline

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026