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

Completed

• Conditions: Trauma; Blood Coagulation Disorders; Thrombotic Disorders; Hemorrhagic Disorders
• Interventions: Other: Routine hemostasis tests; Other: Fibrin structure (FS); Other: Thromboelastography (TEG); Other: Specialized hemostasis tests

• Registration Number: NCT02856789
• Lead Sponsor: Diagnostica Stago R&D

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.

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.

Study Timeline

• Study First Submitted: 2016-07-08
• Study Start: 2016-08
• Study First Submitted QC: 2016-08-02
• Study First Posted: 2016-08-05
• Primary Completion: 2019-03
• Study Completion: 2020-03
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 913

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers (HV)	Specialized hemostasis tests	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
Patients with coagulation disorders	Fibrin structure (FS)	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)
Patients without coagulation disorder	Thromboelastography (TEG)	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)
Healthy volunteers (HV)	Routine hemostasis tests	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
Patients without coagulation disorder	Fibrin structure (FS)	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)
Patients with coagulation disorders	Routine hemostasis tests	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)
Patients with coagulation disorders	Thromboelastography (TEG)	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)
Healthy volunteers (HV)	Fibrin structure (FS)	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
Healthy volunteers (HV)	Thromboelastography (TEG)	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
Patients without coagulation disorder	Routine hemostasis tests	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)

Primary Outcome Measures

Name	Time	Method
Dynamic evolution of fibrin formation	12 months	Evolution of the optical density measurement and calculating the fibrinogen level and coagulolytic balance
Dynamic evolution of the number of protofibrils	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 Outcome Measures

Name	Time	Method
Activated Partial Thromboplastin Time (APTT)	12 months	These assays will be performed at Stago on all samples from healthy volunteers (HV) and patients to allow the biological confirmation of normal samples from HV group. In case of one abnormal result, the sample is considered as not relevant for the normal range determination of Fibrin Structure measurement and will be discarded from HV group.
Thrombin Time (TT)	12 months	These assays will be performed at Stago on all samples from healthy volunteers (HV) and patients to allow the biological confirmation of normal samples from HV group. In case of one abnormal result, the sample is considered as not relevant for the normal range determination of Fibrin Structure measurement and will be discarded from HV group.
Prothrombin Time (PT)	12 months	These assays will be performed at Stago on all samples from healthy volunteers (HV) and patients to allow the biological confirmation of normal samples from HV group. In case of one abnormal result, the sample is considered as not relevant for the normal range determination of Fibrin Structure measurement and will be discarded from HV group.
Thromboelastography measurement on TEG 5000	12 months	Thromboelastography will be performed on two plasma groups, the first group is constituted with fresh healthy volunteers and the second one with fresh patients. Viscoelastic clot parameters will be determined on TEG 5000. Thromboelastography is processed to determine the most relevant parameters to discriminate patients from normal range and the correlation between assays.
Fibrinogen	12 months	These assays will be performed at Stago on all samples from healthy volunteers (HV) and patients to allow the biological confirmation of normal samples from HV group. In case of one abnormal result, the sample is considered as not relevant for the normal range determination of Fibrin Structure measurement and will be discarded from HV group.
D-Dimers	12 months	These assays will be performed at Stago on all samples from healthy volunteers (HV) and patients to allow the biological confirmation of normal samples from HV group. In case of one abnormal result, the sample is considered as not relevant for the normal range determination of Fibrin Structure measurement and will be discarded from HV group.

Trial Locations

Locations (1)

Hôpital d'Instruction des armées Percy - Laboratoire d'Hématologie; 🇫🇷 Clamart, France