Thrombophilia Assessment Under DOAC: Effectiveness of Activated Charcoal

Thrombophilia Clinical Trial

— DOAC-Stop  

Official title:

Thrombophilia Assessment Under Direct Oral Anticoagulants (DOAC): Efficacy of Activated Charcoal

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06171984
• Other study ID #: 8673
• Status: Recruiting
• Start date: July 19, 2022
• Est. completion date: January 19, 2024

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: Agathe HERB, PharmD
• Phone: 33 3 88 12 75 53
• Email: agathe.herb[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Direct oral anticoagulants (DOAC) are anticoagulant molecules that act either directly on factor Xa (Apixaban, Rivaroxaban) or on factor IIa (Dabigatran).

AODs interfere with most coagulation tests, especially those performed by chronometric technique.

For this reason, part of the thrombophilia workup (protein S, search for lupus anticoagulants, antithrombin for patients on dabigatran) cannot be performed on DOACs at the HUS.

Recent studies have highlighted the effectiveness of activated charcoal to adsorb DOACs in order to perform certain hemostasis tests.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 19, 2024
• Est. primary completion date: January 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Adult subject (= 18 years of age)

• Blood sample already analyzed in a usual way in the laboratory as part of the care

• Subject not objecting to the reuse of his or her medical data for scientific research purposes.

Exclusion criteria:

• Insufficient sample

Related Conditions & MeSH terms

• Thrombophilia

Locations

Country	Name	City	State
France	Laboratoire d'Hématologie - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interference or not of activated charcoal in the measurement of protein S, antithrombin, and in the search for lupus anticoagulants.	This study compares the results of two diagnostic techniques (Thrombophilia work-up under direct oral anticoagulants (DOACs)), one using activated charcoal versus another not using it	Through study completion, an average of 6 months