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Periprocedural Direct Oral Anticoagulant Management

NCT03182218 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1100

Last updated 2018-08-02

No results posted yet for this study

Summary

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.

Conditions

  • Periprocedural Complication

Interventions

DRUG

Direct oral anticoagulant

Time of direct oral anticoagulant withdrawal Use or not of bridging with low molecular weight heparin

Sponsors & Collaborators

  • Fundación para la Investigación del Hospital Clínico de Valencia

    lead OTHER

Principal Investigators

  • Raquel Ferrandis Comes, Doctor · Fundación para la Investigación del Hospital Clínico de Valencia

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2018-02-28
Completion
2018-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03182218 on ClinicalTrials.gov