NCT05026281: BOA

Bleeding Oral Anticoagulant Analyzer (BOA)

Completed NA Last updated 7 February 2024

What this trial tests

NA trial testing Quantra analyzer in Anticoagulants and Bleeding Disorders in 80 participants. Completed in 31 January 2024.

Timeline

16 December 2021

Primary endpoint
31 January 2024

31 January 2024

Quick facts

Lead sponsor	University Hospital, Clermont-Ferrand
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Enrollment	80
Start date	16 December 2021
Primary completion	31 January 2024
Estimated completion	31 January 2024
Sites	6 locations across France

Drugs / interventions tested

• Quantra analyzer

Conditions studied

• Anticoagulants and Bleeding Disorders — all drugs for Anticoagulants and Bleeding Disorders →

Sponsor

University Hospital, Clermont-Ferrand

Who can join

18 and older, any sex, with Anticoagulants and Bleeding Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.