NCT06171984

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 19, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 6, 2022

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2024

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

September 6, 2022

Last Update Submit

December 12, 2023

Conditions

Thrombophilia

Keywords

Thrombophiliadirect oral anticoagulantsDOACApixabanRivaroxabanDabigatranHemostasis tests

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult subject (≥ 18 years of age) with blood sample already analyzed in a usual way in the laboratory of HUS as part of the care

You may qualify if:

  • 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.

You may not qualify if:

  • \- Insufficient sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire d'Hématologie - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Thrombophilia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Agathe HERB, PharmD

CONTACT

33 3 88 12 75 53agathe.herb@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2022

First Posted

December 15, 2023

Study Start

July 19, 2022

Primary Completion

January 1, 2024

Study Completion

January 19, 2024

Last Updated

December 15, 2023

Record last verified: 2023-12

Locations

FR(1)