Per-procedural Concentration of Direct Oral Anticoagulants

NCT ID: NCT02643992

Last Updated: 2017-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

270 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-01-31

Brief Summary

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Background: Peri-procedural management of direct oral anticoagulants (DOAC) is challenging. The optimal duration of pre-procedural discontinuation that guarantees a minimal DOAC concentration (\[DOAC\]) at surgery is unknown. The usual 48-hour discontinuation might not be sufficient for all patients.

Objectives: To investigate the factors associated with per-procedural \[DOAC\]. To test the hypothesis that a 48-hour DOAC discontinuation is not sufficient to ensure a minimal perprocedural \[DOAC\], defined as \[DOAC\] \< 30 ng/mL.

Methods: Patients treated with DOAC, and requiring any invasive procedure will be included in this multicentre, prospective, observational study. \[DOAC\], will be measured during invasive procedure.

Detailed Description

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Conditions

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Per-procedural Concentrations of Oral Anticoagulants

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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DOAC concentration measurement

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patient over 18 years-old
* undergoing invasive procedure
* treated with DOAC

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondation Ophtalmologique Adolphe de Rothschild (FOR)

Paris, , France

Site Status

Countries

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France

References

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Godier A, Martin AC, Lessire S, Mullier F, Leblanc I, Gouin-Thibault I. Concentrations of direct oral anticoagulants according to guidelines for the periprocedural management of low bleeding risk procedures. Anaesth Crit Care Pain Med. 2020 Feb;39(1):121-122. doi: 10.1016/j.accpm.2019.04.004. Epub 2019 Apr 13. No abstract available.

Reference Type DERIVED
PMID: 30991108 (View on PubMed)

Other Identifiers

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AGR_2014-13

Identifier Type: -

Identifier Source: org_study_id

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