Bleeding Oral Anticoagulant Analyzer (BOA)

NCT05026281 | Completed DMC

• 2 other identifiers: AOI 2020 TEISSANDIER2020-A03240-39
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 6

Brief 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

Keywords

Haemorrhage; Anticoagulant; Emergency; Quantra analyzer

Outcome Measures

Primary Outcomes (2)

• change in viscoelastic hemostasis parameters assessed by the Quantra® system in the context of severe bleeding occurring under oral anticoagulants (VKA or DOA)

  Quantra® parameters were measured during the patient's therapeutic monitoring (before and after) without prioritization. The parameters of Quantra® are: CT / CTH ratio clotting time overall stiffness of the clot (hPa) Contribution of platelets to clot stiffness (hPa) Contribution of fibrinogen to clot stiffness (hPa)

  Hour 0 and Hour 0+30min

• Change in viscoelastic hemostasis parameters assessed by the Quantra® system in the context of severe bleeding occurring under oral anticoagulants (VKA or DOA)

  Quantra® parameters were measured during the patient's therapeutic monitoring (before and after) without prioritization. The parameters of Quantra® are: CT : clotting time (in seconds) CTH clotting time with heparinase (in seconds)

  Hour 0 and Hour 0+30min

Secondary Outcomes (18)

• Coagulation test

  Hour 0; Hour 0+30min; Hour 0+6 hours

• Coagulation test

  Hour 0; Hour 0+30min; Hour 0+6 hours

• Coagulation test

  Hour 0; Hour 0+30min; Hour 0+6 hours

• Coagulation test

  Hour 0; Hour 0+30min; Hour 0+6 hours

• Coagulation test

  Hour 0; Hour 0+30min; Hour 0+6 hours

Study Arms (1)

Group 1

EXPERIMENTAL

at H0 and H0+30min = blood sample taken

Device: Quantra analyzer

Interventions

Quantra analyzer DEVICE

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

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient, male or female, treated long term with an oral anticoagulant (anti-vitamin K or direct), admitted to a hospital emergency department for intracerebral, digestive or intramuscular hemorrhage, defined as major according to the criteria of the International Society of Thrombosis and Haemostasis1. These three sites of bleeding are the most common.
• Capable of giving informed consent to participate in research or in the event of emergency care for a reference person.
• Affiliated with a Social Security scheme.

You may not qualify if:

• Incapable major.
• Administration within the last 24 hours of parenteral anticoagulant.
• Refusal of participation.
• Pregnant or breast feeding mother

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Hôpital Edouard Herriot: collaborator
• University Hospital of Saint-Etienne: collaborator
• University Hospital, Grenoble: collaborator
• University Hospital, Tours: collaborator
• Pitié-Salpêtrière Hospital: collaborator

Study Sites (6)

University Hospital

Clermont-Ferrand, 63100, France

Location

Grenoble University Hospital

Grenoble, 38043, France

Location

Edouard Herriot University Hospital

Lyon, 69000, France

Location

La Pitié-Salpétrière

Paris, France

Location

Saint Etienne University Hospital

Saint-Etienne, 42055, France

Location

Tours University Hospital

Tours, 37044, France

Location

MeSH Terms

Conditions

Hemostatic Disorders; Hemorrhage; Emergencies

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Dorian Teissandier

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: H0 : blood analyse with Quantra® H0+30 min : blood analyse with Quantra® D0+30 : end of study

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 30, 2021
• Study Start: December 16, 2021
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: February 7, 2024

Record last verified: 2022-09

Locations

FR (6)