Determination of Fibrin Activity in Plasma on STA-R® Prototype (FAST)

Diagnostica Stago

Status: Completed

Conditions: Trauma; Hemorrhagic Disorders; Blood Coagulation Disorders; Thrombotic Disorders

Treatments: Other: Specialized hemostasis tests; Other: Thromboelastography (TEG); Other: Routine hemostasis tests; Other: Fibrin structure (FS)

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT02856789

FAST STUDY 2016-A00869-42

Details and patient eligibility

About

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.

Full 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.

The study is conducted in compliance with French regulation after ethics approval.

FS Assays. The FS determinations on STA-R® prototype and those on TEG® will be realized with fresh plasmas and whole blood samples respectively at the Hôpital d'Instruction des armées Percy. The screening tests (PT, APTT, and Fibrinogen) on STA-R® Evolution and the measurement of FS on a second STA-R® prototype will be performed with frozen plasmas at STAGO laboratory.

Statistical analysis of results. A statistical analysis will determine the most relevant parameters in the discrimination of the pathologic population from the normal population, and the quality control precision. Then, statistical analysis will compare STA-R® prototype method to the TEG® method to point out the most populations discriminating method.

Enrollment: 913 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

913 participants in 3 patient groups

Healthy volunteers (HV)

Description:

HV without any known treatment, without any coagulation trouble and with normal hemostasis results. FS and TEG will be processed to define the most relevant parameters for normal range and the correlation between both assays. Tests performed on HV : * Routine hemostasis tests * Fibrin structure (FS) * Thromboelastography (TEG) * Specialized hemostasis tests

Treatment:

Other: Routine hemostasis tests

Other: Thromboelastography (TEG)

Other: Fibrin structure (FS)

Other: Specialized hemostasis tests

Patients without coagulation disorder

Description:

Hospitalized patients without coagulation disorder or abnormal hemostasis and hematological results and witout ongoing treatment (mainly anticoagulant treatment). FS and TEG will be processed to determine the most relevant parameters to discriminate patients from normal range and the correlation between assays. Tests performed on patients : * Routine hemostasis tests * Fibrin structure (FS) * Thromboelastography (TEG)

Treatment:

Other: Routine hemostasis tests

Other: Thromboelastography (TEG)

Other: Fibrin structure (FS)

Patients with coagulation disorders

Description:

Hospitalized patients with coagulation disorders, mainly trauma patients or abnormal hemostasis and hematological results, mainly decreased fibrinogen level . FS and TEG will be processed to determine the most relevant parameters to discriminate patients from normal range and the correlation between assays. Tests performed on patients : * Routine hemostasis tests * Fibrin structure (FS) * Thromboelastography (TEG)

Treatment:

Other: Routine hemostasis tests

Other: Thromboelastography (TEG)

Other: Fibrin structure (FS)