Clinical trial NCT02856789: Determination of Fibrin Activity in Plasma on STA-R® Prototype
Official title: Determination of Fibrin Activity in Plasma on STA-R® Prototype
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Coagulation Disorders
Thrombotic Disorders
Hemorrhagic Disorders
Trauma
Keywords: Fibrin structure
Coag-Lysis assay
Fibrin formation
Fibrinolysis
TEG 5000
TEG 6S
Coagulo-lytic balance
Normal range
Thromboelastography
Lead sponsor: Diagnostica Stago R&D
Sponsor class: INDUSTRY
Collaborators: name: Hôpital d'Instruction des armées Percy
First posted: 2016-08-05
Enrollment: 913
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volonteers from Centre de Transfusion des Armées (CTSA) and from Centre Principal d'Expertise Médicale du Personnel Navigant (CPEMPN).

Percy hospital patients from at least: Emergency Unit (EU), Intensive Care Unit (ICU), Burnt Treatment Center (BTC), Hematology department.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Dynamic evolution of the number of protofibrils
timeFrame: 12 months
measure: Dynamic evolution of fibrin formation
timeFrame: 12 months
Secondary outcomes:
measure: Thromboelastography measurement on TEG 5000
timeFrame: 12 months
measure: Prothrombin Time (PT)
timeFrame: 12 months
measure: Thrombin Time (TT)
timeFrame: 12 months
measure: Activated Partial Thromboplastin Time (APTT)
timeFrame: 12 months
measure: Fibrinogen
timeFrame: 12 months
measure: D-Dimers
timeFrame: 12 months
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital d'Instruction des armées Percy - Laboratoire d'Hématologie
Study officials:
affiliation: Hôpital d'Instruction des armées Percy
name: Vincent Foissaud, M D
role: PRINCIPAL_INVESTIGATOR
affiliation: Diagnostica Stago SAS
name: Geneviève Contant, Ph D
role: STUDY_DIRECTOR
References:
citation: Yeromonahos C, Polack B, Caton F. Nanostructure of the fibrin clot. Biophys J. 2010 Oct 6;99(7):2018-27. doi: 10.1016/j.bpj.2010.04.059.
citation: Zabczyk M, Undas A. Plasma fibrin clot structure and thromboembolism: clinical implications. Pol Arch Intern Med. 2017 Dec 22;127(12):873-881. doi: 10.20452/pamw.4165. Epub 2017 Dec 11.
citation: Pieters M, Philippou H, Undas A, de Lange Z, Rijken DC, Mutch NJ; Subcommittee on Factor XIII and Fibrinogen, and the Subcommittee on Fibrinolysis. An international study on the feasibility of a standardized combined plasma clot turbidity and lysis assay: communication from the SSC of the ISTH. J Thromb Haemost. 2018 May;16(5):1007-1012. doi: 10.1111/jth.14002. Epub 2018 Apr 15. No abstract available.