Bleeding Oral Anticoagulant Analyzer (BOA)

Summary

The quality of the reversion of these serious hemorrhagic accidents under oral anticoagulants depends on the adequate use of reversion products but also on the speed of obtaining hemostasis data allowing to evaluate the effectiveness of this "chemical" hemostasis. .

Clot formation can be studied using different visco-elastic methodologies (thromboelastography or thromboelastometry) with a detectable change in clot formation with oral anticoagulants.

These techniques have been proven in patients who are often unstable and present with severe trauma with hemorrhagic shock, thus making it possible to guide the transfusion protocol. However, the level of recommendations in these patients, who are often polyhydrated and poly-transfused, is grade 1c due to small-scale studies with difficulty in analyzing the values of the visco-elasticity parameters in these patients. In addition, these methods are little used in current practice because of their difficult reading.

The use of visco-elastic methods in patients on oral anticoagulants has been little studied. However, taking an oral anticoagulant mainly causes coagulation disorders. The use of these methods would make it possible to assess the impact of the anticoagulant on hemostasis and to verify the correct reversion of hemostasis parameters. Quantra®, one of the visco-elastic methods, would make it possible to speed up the evaluation in the context of biology relocated to the patient's bed with a simplified reading of the factors involved in the formation of the clot in order to allow an immediate evaluation the quality of the reversion performed which may have an impact on the re-administration of reversion products or even an adaptation of the dose of reversion products according to the initial parameters at the time of severe bleeding before reversion. The objective of this pilot study is to study the metrological evolution, before and after reversion, of the hemostasis parameters evaluated by the Quantra® system from HemoSonics in a patient being his own control in the context of a severe hemorrhage occurring on oral anticoagulants (VKA or DOA).

Conditions

• Anticoagulants and Bleeding Disorders

Interventions

DEVICE

Quantra analyzer

one additional tube will be collected during the usual blood test at two different time and analyzed by Quantra ®

Sponsors & Collaborators

• Hôpital Edouard Herriot

  collaborator OTHER

• University Hospital of Saint-Etienne

  collaborator OTHER

• University Hospital, Grenoble

  collaborator OTHER

• University Hospital, Tours

  collaborator OTHER

• Pitié-Salpêtrière Hospital

  collaborator OTHER

• University Hospital, Clermont-Ferrand

  lead OTHER

Principal Investigators

• Dorian Teissandier · University Hospital, Clermont-Ferrand

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-16

Primary Completion

2024-01-31

Completion

2024-01-31

Countries

• France

Study Locations