Per-procedural Concentration of Direct Oral Anticoagulants | NCT02643992

Studies
Per-procedural Concentration of Direct Oral Anticoagulants

NCT02643992

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Status

Completed

Last Update Posted

Feb 6, 2017Estimated

Enrollment

270Actual

Phase

Not provided

Conditions

Per-procedural Concentrations of Oral Anticoagulants

Interventions

DOAC concentration measurement

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

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Jan 2016Actual

Completion Date

Jan 2016Actual

First Submitted Date

Dec 30, 2015

First Submission Date that Met QC Criteria

Dec 30, 2015

First Posted Date

Dec 31, 2015Estimated

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

Feb 3, 2017

Last Update Posted Date

Feb 6, 2017Estimated

Description Module

Brief Summary

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

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

270Actual

Name	Type	Description	Arm Group Labels	Other Names
DOAC concentration measurement	Other

Measure	Description	Time Frame
DOAC concentration		beginning of invasive procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

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

patient undergoing invasive procedure and treated with DOAC

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Ophtalmologique Adolphe de Rothschild (FOR)		Paris		75019	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30991108	Derived	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.