Periprocedural Direct Oral Anticoagulant Management

NCT03182218 | Completed DMC

• 1 other identifier: INC-ACO-2013-01
• Study Type: observational
• Target: 1,100
• Locations: 1 country
• Sites: 30

Brief 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

Keywords

Periprocedural; Anticoagulation; Dabigatran; Rivaroxaban; Apixaban; Edoxaban; Direct oral anticoagulant; Surgery; Anaesthesia; Novel oral anticoagulant; Perioperative medicine

Outcome Measures

Primary Outcomes (2)

• Periprocedural thrombotic complications

  Accumulative incidence rate of thrombotic events (cardiovascular, neurological, or venous thromboembolic event)

  1 month

• Periprocedural hemorrhagic complications

  Accumulative incidence rate of minor and major bleeding events

  1 month

Secondary Outcomes (2)

• Outcome of bridging therapy

  Between one week before and one month after procedural

• Knowing actual DOAC management in clinical practice

  Between one week before and one month after procedural

Interventions

Direct oral anticoagulant DRUG

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

Also known as: low molecular weight heparin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (30)

Hospital de Mataró

Mataró, Barcelona, 08304, Spain

Location

Hospital de Sabadell-Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Severo Ochoa

Leganés, Madrid, 28911, Spain

Location

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

Hospital de Manises

Manises, Valencia, 46940, Spain

Location

Hospital Universitario La Ribera

Alzira, 46600, Spain

Location

Parc Salut Mar

Barcelona, 08003, Spain

Location

Fundació Puigvert

Barcelona, 08025, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital de Galdakao-Usánsolo

Galdakao, 48960, Spain

Location

Hospital Universitario de Getafe

Getafe, 28905, Spain

Location

Hospital Universitario de Gran Canaria Doctor Negrín

Las Palmas de Gran Canaria, 35012, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28009, Spain

Location

Hospital Universitario Infanta Leonor

Madrid, 28031, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Costa del Sol

Marbella, 29600, Spain

Location

Hospital Virgen de la Victoria

Málaga, 29010, Spain

Location

Hospital Universitario de Móstoles

Móstoles, 28935, Spain

Location

Clínica Universidad de Navarra

Pamplona, 31008, Spain

Location

Hospital General de Segovia

Segovia, 40006, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

Location

Hospital Virgen de la Salud

Toledo, 45004, Spain

Location

Hospital Clínico Universitario

Valencia, 46010, Spain

Location

Consorcio H. General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Universitari i Politècnic La Fe

Valencia, 46016, Spain

Location

Hospital Dr Peset

Valencia, 46017, Spain

Location

Hospital Lluís Alcanyís

Xàtiva, 46800, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (13)

• Perez-Villacastin J, Perez Castellano N, Moreno Planas J. Epidemiology of atrial fibrillation in Spain in the past 20 years. Rev Esp Cardiol (Engl Ed). 2013 Jul;66(7):561-5. doi: 10.1016/j.rec.2013.02.012. Epub 2013 May 28.

  PMID: 24776206 BACKGROUND

• Barrios V, Calderon A, Escobar C, de la Figuera M; Primary Care Group in the Clinical Cardiology Section of the Spanish Society of Cardiology. Patients with atrial fibrillation in a primary care setting: Val-FAAP study. Rev Esp Cardiol (Engl Ed). 2012 Jan;65(1):47-53. doi: 10.1016/j.recesp.2011.08.008. Epub 2011 Nov 4. English, Spanish.

  PMID: 22054913 BACKGROUND

• Cea-Calvo L, Redon J, Marti-Canales JC, Lozano JV, Llisterri JL, Fernandez-Perez C, Aznar J, Gonzalez-Esteban J. [Prevalence of low glomerular filtration rate in the elderly population of Spain. The PREV-ICTUS study]. Med Clin (Barc). 2007 Nov 17;129(18):681-7. doi: 10.1157/13112509. Spanish.

  PMID: 18021608 BACKGROUND

• Weitz JI, Eikelboom JW, Samama MM. New antithrombotic drugs: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e120S-e151S. doi: 10.1378/chest.11-2294.

  PMID: 22315258 BACKGROUND

• Wittkowsky AK. Novel oral anticoagulants and their role in clinical practice. Pharmacotherapy. 2011 Dec;31(12):1175-91. doi: 10.1592/phco.31.12.1175.

  PMID: 22122180 BACKGROUND

• Mavrakanas T, Bounameaux H. The potential role of new oral anticoagulants in the prevention and treatment of thromboembolism. Pharmacol Ther. 2011 Apr;130(1):46-58. doi: 10.1016/j.pharmthera.2010.12.007. Epub 2010 Dec 24.

  PMID: 21185864 BACKGROUND

• Llau JV, Ferrandis R, Castillo J, de Andres J, Gomar C, Gomez-Luque A, Hidalgo F, Torres LM. [Recommendations on use of direct oral anticoagulants in the perioperative period]. Med Clin (Barc). 2012 Oct;139 Suppl 2:46-50. doi: 10.1016/S0025-7753(12)70042-8. Spanish.

  PMID: 23498073 BACKGROUND

• van Ryn J, Stangier J, Haertter S, Liesenfeld KH, Wienen W, Feuring M, Clemens A. Dabigatran etexilate--a novel, reversible, oral direct thrombin inhibitor: interpretation of coagulation assays and reversal of anticoagulant activity. Thromb Haemost. 2010 Jun;103(6):1116-27. doi: 10.1160/TH09-11-0758. Epub 2010 Mar 29.

  PMID: 20352166 BACKGROUND

• Turpie AG, Kreutz R, Llau J, Norrving B, Haas S. Management consensus guidance for the use of rivaroxaban--an oral, direct factor Xa inhibitor. Thromb Haemost. 2012 Nov;108(5):876-86. doi: 10.1160/TH12-03-0209. Epub 2012 Sep 26.

  PMID: 23014816 BACKGROUND

• Schulman S, Crowther MA. How I treat with anticoagulants in 2012: new and old anticoagulants, and when and how to switch. Blood. 2012 Mar 29;119(13):3016-23. doi: 10.1182/blood-2011-10-378950. Epub 2012 Feb 1.

  PMID: 22302737 BACKGROUND

• Gallego P, Apostolakis S, Lip GY. Bridging evidence-based practice and practice-based evidence in periprocedural anticoagulation. Circulation. 2012 Sep 25;126(13):1573-6. doi: 10.1161/CIRCULATIONAHA.112.135681. No abstract available.

  PMID: 23008469 BACKGROUND

• Llau JV, Ferrandis R. Letter by Llau and Ferrandis regarding article, "Bridging evidence-based practice and practice-based evidence in periprocedural anticoagulation". Circulation. 2013 May 14;127(19):e616. doi: 10.1161/CIRCULATIONAHA.112.151506. No abstract available.

  PMID: 23671184 BACKGROUND

• Ferrandis R, Castillo J, de Andres J, Gomar C, Gomez-Luque A, Hidalgo F, Llau JV, Sierra P, Torres LM. The perioperative management of new direct oral anticoagulants: a question without answers. Thromb Haemost. 2013 Sep;110(3):515-22. doi: 10.1160/TH12-11-0868. Epub 2013 Jul 11.

  PMID: 23846475 BACKGROUND

MeSH Terms

Interventions

N(4)-oleylcytosine arabinoside; Heparin, Low-Molecular-Weight

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Raquel Ferrandis Comes, Doctor

  Fundación para la Investigación del Hospital Clínico de Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 9, 2017
• Study Start: February 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 2, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (30)