Thrombophilia Assessment Under DOAC: Effectiveness of Act... | NCT06171984

Studies
Thrombophilia Assessment Under DOAC: Effectiveness of Activated Charcoal

NCT06171984

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Dec 15, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Thrombophilia

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 19, 2022Actual

Primary Completion Date

Jan 2024Estimated

Completion Date

Jan 19, 2024Estimated

First Submitted Date

Sep 6, 2022

First Submission Date that Met QC Criteria

Dec 12, 2023

First Posted Date

Dec 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2023

Last Update Posted Date

Dec 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Agathe HERB, PharmD	Contact	33 3 88 12 75 53		agathe.herb@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laboratoire d'Hématologie - CHU de Strasbourg - France	Recruiting	Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D019851	Thrombophilia

Ancestor Terms

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided