Periprocedural Direct Oral Anticoagulant Management (RA-ACOD)

August 1, 2018 updated by: Raquel Ferrandis, Fundación para la Investigación del Hospital Clínico de Valencia

Prospective Observational Study of the Direct Oral Anticoagulants Periprocedural Management

Direct oral anticoagulants (DOAC) are a new drug group that has been approved for chronic anticoagulation of patients in atrial fibrillation or suffering acute thrombosis, between others. The need of surgery of a patient in atrial fibrillation is round 10% per year.

Due to DOAC short time of commercialization and the lack of experience, the proper management of DOAC when a patient in this treatment needs a scheduled or urgent procedure, has not yet been established. This fact may mean both the decrease of the anticoagulant treatment efficacy and the increase of the haemorrhage complications in the perioperative period.

With the aim of gaining additional information about this aspect, a multicentre, prospective and observational study (classified by the spanish drug society, AEMPS, as non-interventional trial, EPA-SP) about the DOAC management, before a scheduled or urgent surgery, in normal clinical practice, is proposed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

When an anticoagulated patient is scheduled for surgery or an invasive procedure, the physician's worry is how to achieve needing an optimal haemostasis without increasing the risk of thrombosis. For decades, the main drug for chronic anticoagulation has been antivitamin-k (warfarin or acenocoumarol). In the majority of patients, the periprocedural management proposal has been stopping the drug and giving a short acting anticoagulant for some days before surgery, known as bridging therapy strategy, mostly done with a low-molecular weight heparin (LMWH).

The debate about the best perioperative management of the anticoagulated patients has increased with the arrival on the market of direct oral anticoagulants (DOAC), by the moment approved for long-term anticoagulation in patients with atrial fibrillation and for the treatment of pulmonary embolism. DOAC could be classified in two groups: direct inhibitors of thrombin (the only current available drug is dabigatran) and direct inhibitors of factor Xa (rivaroxaban, apixaban, edoxaban, and others soon to come). DOAC have pharmacokinetic characteristics that seem to favour stopping the drug for some days without substitution in the vast majority of the patients. Nevertheless, current lack of experience in the management of high doses of DOAC during the perioperative period, the absence of effective antagonists to reverse the anticoagulation, the unsuitable standardized laboratory monitoring and, also, the different pharmacokinetics between patients receiving these drugs, have made challenging to standardize the optimal management in the perioperative period. Some proposals have been published in last years from expert consensus, based on pharmacokinetic data, but DOAC short time of commercialization and the difficulties to interpret the post-hoc analysis from the randomized trials, for the heterogeneity of the included population and the wide kind of surgeries, most of them with low bleeding risk, have moved the spanish working group on perioperative management of haemostasis to plan a multi-institutional registry to gain experience and information in the periprocedural (urgent or scheduled) management of DOAC.

The authors designed an observational, prospective, multicentre study including patients under long-term DOAC treatment for atrial fibrillation or treatment of venous thromboembolism who are scheduled or need an urgent procedure. Data collected were demographic, related with the DOAC management and with the possible haemorrhagic or thrombotic events with a follow-up of 30 day. A univariable analysis and a multivariate regression model were applied using all the available co-variables. Bilateral hypothesis contrast were considered significant if α < 0.05.

Study Type

Observational

Enrollment (Actual)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alzira, Spain, 46600
        • Hospital Universitario La Ribera
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08025
        • Fundacio Puigvert
      • Barcelona, Spain, 08003
        • Parc Salut Mar
      • Cadiz, Spain, 11009
        • Hospital Puerta del Mar
      • Galdakao, Spain, 48960
        • Hospital de Galdakao-Usansolo
      • Getafe, Spain, 28905
        • Hospital Universitario de Getafe
      • Las Palmas de Gran Canaria, Spain, 35012
        • Hospital Universitario de Gran Canaria Doctor Negrín
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28031
        • Hospital Universitario Infanta Leonor
      • Madrid, Spain, 28009
        • Hospital General Universitario Gregorio Maranon
      • Malaga, Spain, 29010
        • Hospital Virgen de la Victoria
      • Marbella, Spain, 29600
        • Hospital Costa del Sol
      • Móstoles, Spain, 28935
        • Hospital Universitario de Mostoles
      • Pamplona, Spain, 31008
        • Clinica Universidad de Navarra
      • Segovia, Spain, 40006
        • Hospital General de Segovia
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío
      • Toledo, Spain, 45004
        • Hospital Virgen De La Salud
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario
      • Valencia, Spain, 46017
        • Hospital Dr Peset
      • Valencia, Spain, 46016
        • Hospital Universitari i Politècnic La Fe
      • Valencia, Spain, 46014
        • Consorcio H. General Universitario de Valencia
      • Xàtiva, Spain, 46800
        • Hospital Lluis Alcanyis
      • Zaragoza, Spain, 50009
        • Hospital Miguel Servet
    • Barcelona
      • Mataró, Barcelona, Spain, 08304
        • Hospital de Mataro
      • Sabadell, Barcelona, Spain, 08208
        • Hospital de Sabadell-Parc Taulí
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marques de Valdecilla
    • Madrid
      • Leganés, Madrid, Spain, 28911
        • Hospital Universitario Severo Ochoa
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
    • Valencia
      • Manises, Valencia, Spain, 46940
        • Hospital de Manises

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patient under treatment with direct oral anticoagulant who requires a surgery or an invasive procedural, both scheduled or urgent.

Description

Inclusion Criteria:

  • Patients 18 years of age and older
  • Under direct oral anticoagulant
  • Urgent or scheduled surgery or invasive procedure needed
  • Signed and dated informed consent form

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Periprocedural thrombotic complications
Time Frame: 1 month
Accumulative incidence rate of thrombotic events (cardiovascular, neurological, or venous thromboembolic event)
1 month
Periprocedural hemorrhagic complications
Time Frame: 1 month
Accumulative incidence rate of minor and major bleeding events
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome of bridging therapy
Time Frame: Between one week before and one month after procedural
Relationship between the incidence of complications and the use of bridging therapy.
Between one week before and one month after procedural
Knowing actual DOAC management in clinical practice
Time Frame: Between one week before and one month after procedural
Composite of time of withdrawal of direct oral anticoagulant, use or not of low molecular weight heparin as bridge therapy, time of reintroduction of direct oral anticoagulant
Between one week before and one month after procedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Investigators

  • Principal Investigator: Raquel Ferrandis Comes, Doctor, Fundación para la Investigación del Hospital Clínico de Valencia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 8, 2017

First Posted (Actual)

June 9, 2017

Study Record Updates

Last Update Posted (Actual)

August 2, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INC-ACO-2013-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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