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

NCT02856789 | Completed

• 1 other identifier: FAST STUDY 2016-A00869-42
• Study Type: observational
• Target: 913
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• Dynamic evolution of fibrin formation

  Evolution of the optical density measurement and calculating the fibrinogen level and coagulolytic balance

  12 months

Secondary Outcomes (6)

• Thromboelastography measurement on TEG 5000

  12 months

• Prothrombin Time (PT)

  12 months

• Thrombin Time (TT)

  12 months

• Activated Partial Thromboplastin Time (APTT)

  12 months

• Fibrinogen

  12 months

Study Arms (3)

Healthy volunteers (HV)

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

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

Patients without coagulation disorder

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)

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

Patients with coagulation disorders

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)

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

Interventions

Routine hemostasis tests OTHER

Prothrombin Time (PT),Thrombin Time (TT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, D-Dimers

Healthy volunteers (HV); Patients with coagulation disorders; Patients without coagulation disorder

Fibrin structure (FS) OTHER

FS will be determined on STA-R® prototype at Percy and at Stago

Healthy volunteers (HV); Patients with coagulation disorders; Patients without coagulation disorder

Thromboelastography (TEG) OTHER

Thromboelastography will be processed on TEG® at Percy

Healthy volunteers (HV); Patients with coagulation disorders; Patients without coagulation disorder

Specialized hemostasis tests OTHER

Coagulation factors

Healthy volunteers (HV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Healthy volonteers with ongoing treatment
• Healthy volonteers with abnormal hemostasis results

Sponsors & Collaborators

• Diagnostica Stago R&D: lead
• Hôpital d'Instruction des armées Percy: collaborator

Study Sites (1)

Hôpital d'Instruction des armées Percy - Laboratoire d'Hématologie

Clamart, 92140, France

Location

Related Publications (3)

• 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.

  PMID: 20923635 BACKGROUND

• 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.

  PMID: 29225327 BACKGROUND

• 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.

  PMID: 29658191 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Fresh and frozen citrated Poor Platelets Plasma 200 Healthy volunters 50 Patients without coagulation disorder 650 Patients with coagulation disorder

MeSH Terms

Conditions

Blood Coagulation Disorders; Hemorrhagic Disorders; Wounds and Injuries

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Vincent Foissaud, M D

  Hôpital d'Instruction des armées Percy

  PRINCIPAL INVESTIGATOR

• Geneviève Contant, Ph D

  Diagnostica Stago SAS

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: August 5, 2016
• Study Start: August 1, 2016
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2020
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)