Determination of Fibrin Activity in Plasma on STA-R® Prototype
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 913
- Locations
- 1
- Primary Endpoint
- Dynamic evolution of fibrin formation
Study Overview
Brief Summary
The purpose of the study is to give the proof of concept of the Fibrin structure assay on STA-R® prototype. It aims to identify the parameters which discriminate the pathologic from the normal population. Secondary objectives are to determine the precision of the assay, to record the Fibrin activity, comparatively with thromboelastography on TEG®, in a coagulation activation assay and in a coagulation-lysis assay.
Detailed Description
Background. Fibers thickness of the fibrin clot plays an important role on the clot stability and its resistance to the fibrinolysis. The innovative concept, based on the relationship between light spectrum through the fibrin clot and its fiber nanostructure (C.Dassi et al, ISTH 15ABS-3593), thanks to a multi-wavelength STA-R® prototype, was simplified by using a coag-lysis assay (An international study on the feasibility of a standardized combined plasma clot turbidity and lysis assay: SSC communication ; Pieters et al. ; JTH 2018) Preliminary results suggest that this new automated FS method provides new data on clot analysis and could be a useful tool in clinical practice in the management of hemostasis disorders. This study is extended to begining of march 2019.
Main objective. This study aims to determine the precision, the normal range of the FS method in comparison with Thromboelastography on TEG® and discriminate patients from healthy volunteers (HV).
Recruitment. 200 healthy volunteers without any known coagulation troubles, enrolled during coagulation testing or blood donation.
50 hospitalized patients or patients from consultations, without ongoing treatment (particularly anticoagulant treatment), with a normal hemostasis screening (Prothombin Time, Activated Partial Prothombine Time and Fibrinogen Level).
650 hospitalized patients for any pathology known and able to induce a increase or a decrease of the fibrinogen level, mainly from trauma patients and enrolled during coagulation testing.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients and healthy volunteers with non-opposition to participate in the evaluation
- •Healthy volunteers : from 18 years to 70 years
- •Patients : minimum age limit 18 years - no maximum age limit
Exclusion Criteria
- •Healthy volonteers with ongoing treatment
- •Healthy volonteers with abnormal hemostasis results
Outcomes
Primary Outcomes
Dynamic evolution of fibrin formation
Time Frame: 12 months
Evolution of the optical density measurement and calculating the fibrinogen level and coagulolytic balance
Dynamic evolution of the number of protofibrils
Time Frame: 12 months
Evolution of the Fibrin structure (FS) measurement will be performed on two plasma groups, the first group is constituted with fresh healthy volunteers and the second one with fresh patients. Coagulolytic balance will be measured with FS method. In addition, a normal range will be determined on fresh healthy volunteers without any known coagulation troubles. Fibrin structure is processed to determine the most relevant parameters to discriminate patients from normal range and the correlation between assays.
Secondary Outcomes
- Activated Partial Thromboplastin Time (APTT)(12 months)
- Thrombin Time (TT)(12 months)
- Prothrombin Time (PT)(12 months)
- Thromboelastography measurement on TEG 5000(12 months)
- Fibrinogen(12 months)
- D-Dimers(12 months)