Bleeding Oral Anticoagulant Analyzer (BOA) (BOA)

Intérêt de l'Utilisation du "Quantra® Haemostasis Analyser" Lors de la Prise en Charge Des Patients présentant Une hémorragie Grave Sous Anticoagulant Oral

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).

Study Overview

• Status: Completed
• Conditions: Anticoagulants and Bleeding Disorders
• Intervention / Treatment: Device: Quantra analyzer

Detailed Description

This multicenter, prospective, cohort pilot study of physiopathology and physio-pharmacology, testing the added value of innovative functional exploration in addition to routine monitoring, in patients eligible for urgent reversion from anticoagulant therapy.

This study is part of the patient's routine care without modifying his management. In fact, eligible patients with severe bleeding under oral anticoagulant therapy will be treated according to departmental habits. The study will only consist of the addition of the analysis of a blood sample using the Quantra® before and after reversion without modification of the management.

All patients will be followed for the duration of hospitalization.

Primary objective :

The objective of this pilot study is to study the behavior of viscoelastic hemostasis parameters assessed by the Quantra® System in the context of severe bleeding occurring under oral anticoagulants (VKA or DOA).

Secondary objectives :

To study the effect of reversion of oral anticoagulants on hemostasis parameters assessed by the Quantra® system in the context of severe bleeding.

To study, in the context of severe bleeding, the relationship between the hemostasis parameters assessed by the Quantra® system and:

• conventional hemostasis parameters,
• the severity of the bleeding events before reversion, in the context of severe bleeding,
• recurrent bleeding or thrombotic events occurring during hospitalization.

The primary endpoint will be all of the Quantra® parameter values 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)
• CTR: CT / CTH ratio clotting time
• CS: overall stiffness of the clot (hPa)
• PCS: Contribution of platelets to clot stiffness (hPa) FCS: Contribution of fibrinogen to clot stiffness (hPa)

Secondary endpoints:

• Classic coagulation tests: (TP / INR), TCA, Fibrinogen, FII, FV, FVII, FX
• Drug concentration (for DOA) by dilute thrombin time or specific anti-Xa activity
• Type and volume of filling solutes before reversion
• Assessment of blood loss (Hb, size of the hematoma)
• Clinical outcome of reversion: haemostatic efficacy rate at 24 hours, occurrence of haemorrhagic or thrombotic recurrences during hospitalization
• Duration of hospitalization

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63100
    • University Hospital
  • Grenoble, France, 38043
    • Grenoble University Hospital
  • Lyon, France, 69000
    • Edouard Herriot University Hospital
  • Paris, France
    • La Pitié-Salpétrière
  • Saint-Étienne, France, 42055
    • Saint Etienne University Hospital
  • Tours, France, 37044
    • Tours University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Capable of giving informed consent to participate in research or in the event of emergency care for a reference person.
3. Affiliated with a Social Security scheme.

Exclusion Criteria:

1. Incapable major.
2. Administration within the last 24 hours of parenteral anticoagulant.
3. Refusal of participation.
4. Pregnant or breast feeding mother

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; at H0 and H0+30min = blood sample taken	Device: Quantra analyzer; one additional tube will be collected during the usual blood test at two different time and analyzed by Quantra ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coagulation test	change in activated partial thromboplastin time (APTT) measures	Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test	change in prothrombin time test values	Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test	changes in levels of fibrinogen	Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test	change in Factor II assay	Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test	change in Factor V assay	Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test	change in Factor VII assay	Hour 0; Hour 0+30min; Hour 0+6 hours
Coagulation test	change in Factor X assay	Hour 0; Hour 0+30min; Hour 0+6 hours
anti-factor Xa activity measurement	change in anti-factor Xa activity measurement	Hour 0; Hour 0+30min; Hour 0+6 hours
Type of filling solutes before reversion	Type of filling solutes before reversion	Hour 0
Volume of filling solutes before reversion	Volume of filling solutes before reversion	Hour 0
Evaluation of blood loss	haemoglobin concentration	Hour 0
Evaluation of blood loss	haematoma size	Hour 0
Clinical haemostasis evolution	haematoma volume	Hour 0+24
Clinical haemostasis evolution	Haematoma pain on numeric scale (0-10 points)	Hour 0+24
Clinical issue of reversion	efficacy haemostatic rate at 24 hours	Hour 0+24
Clinical issue of reversion	Recurrence of bleeding during hospitalization	Hour 0+24
Duration of hospitalization	how many days the patient is hospitalized	at the end of hospitalization
phone call	report of any adverse event occured in the month after the end of hospitalization	Month 0+1

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: University Hospital, Grenoble; Hôpital Edouard Herriot; University Hospital, Tours; Pitié-Salpêtrière Hospital; University Hospital of Saint-Etienne
• Investigators: Principal Investigator: Dorian Teissandier, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2021
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Haemorrhage; Emergency; Anticoagulant; Quantra analyzer
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage
• Other Study ID Numbers: AOI 2020 TEISSANDIER; 2020-A03240-39 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No