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

Trauma Clinical Trial

— FAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02856789
• Other study ID #: FAST STUDY 2016-A00869-42
• Status: Completed
• Start date: August 2016
• Est. completion date: March 2020

Study information

• Verified date: August 2020
• Source: Diagnostica Stago R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 913
• Est. completion date: March 2020
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Disease
• Hemorrhagic Disorders
• Hemostatic Disorders
• Thrombosis
• Thrombotic Disorders
• Trauma

Intervention

Other:
• Routine hemostasis tests
Prothrombin Time (PT),Thrombin Time (TT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, D-Dimers
• Fibrin structure (FS)
FS will be determined on STA-R® prototype at Percy and at Stago
• Thromboelastography (TEG)
Thromboelastography will be processed on TEG® at Percy
• Specialized hemostasis tests
Coagulation factors

Locations

Country	Name	City	State
France	Hôpital d'Instruction des armées Percy - Laboratoire d'Hématologie	Clamart

Sponsors (2)

Lead Sponsor	Collaborator
Diagnostica Stago R&D	Hôpital d'Instruction des armées Percy

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic evolution of the number of protofibrils	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.	12 months
Primary	Dynamic evolution of fibrin formation	Evolution of the optical density measurement and calculating the fibrinogen level and coagulolytic balance	12 months
Secondary	Thromboelastography measurement on TEG 5000	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.	12 months
Secondary	Prothrombin Time (PT)	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.	12 months
Secondary	Thrombin Time (TT)	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.	12 months
Secondary	Activated Partial Thromboplastin Time (APTT)	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.	12 months
Secondary	Fibrinogen	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.	12 months
Secondary	D-Dimers	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.	12 months