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

NCT02856789 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 913

Last updated 2020-08-12

No results posted yet for this study

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

Interventions

OTHER

Routine hemostasis tests

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

OTHER

Fibrin structure (FS)

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

OTHER

Thromboelastography (TEG)

Thromboelastography will be processed on TEG® at Percy

OTHER

Specialized hemostasis tests

Coagulation factors

Sponsors & Collaborators

  • Hôpital d'Instruction des armées Percy

    collaborator UNKNOWN

  • Diagnostica Stago R&D

    lead INDUSTRY

Principal Investigators

  • Vincent Foissaud, M D · Hôpital d'Instruction des armées Percy

  • Geneviève Contant, Ph D · Diagnostica Stago SAS

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-03-31
Completion
2020-03-31

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02856789 on ClinicalTrials.gov