Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1100 participants
OBSERVATIONAL
2015-02-28
2018-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Predictive Factors for Response to New Oral Anticoagulants in the Treatment of Non-valvular Atrial Fibrillation..
NCT04297150
Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation
NCT02067182
Pilot Study: Comparison of Patients' Knowledge of Direct Oral Anticoagulants in Post-hospitalization Between 2 Cardiology Departments Offering or Not a Pharmaceutical Interview During Hospitalization
NCT04674202
Observatory of Invasive Procedures and Bleeding in Patients Treated With New Oral Anticoagulants
NCT02185027
Activates Charcoal for Patients Undergoing Invasive Procedure Delayed Due to Direct Oral Anticoagulants
NCT02969746
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Direct oral anticoagulant
Time of direct oral anticoagulant withdrawal Use or not of bridging with low molecular weight heparin
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Under direct oral anticoagulant
* Urgent or scheduled surgery or invasive procedure needed
* Signed and dated informed consent form
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fundación para la Investigación del Hospital Clínico de Valencia
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Raquel Ferrandis
Doctor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Raquel Ferrandis Comes, Doctor
Role: PRINCIPAL_INVESTIGATOR
Fundación para la Investigación del Hospital Clínico de Valencia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital de Mataró
Mataró, Barcelona, Spain
Hospital de Sabadell-Parc Taulí
Sabadell, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Hospital de Manises
Manises, Valencia, Spain
Hospital Universitario La Ribera
Alzira, , Spain
Parc Salut Mar
Barcelona, , Spain
Fundació Puigvert
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Puerta del Mar
Cadiz, , Spain
Hospital de Galdakao-Usánsolo
Galdakao, , Spain
Hospital Universitario de Getafe
Getafe, , Spain
Hospital Universitario de Gran Canaria Doctor Negrín
Las Palmas de Gran Canaria, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Universitario Infanta Leonor
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Costa del Sol
Marbella, , Spain
Hospital Virgen de la Victoria
Málaga, , Spain
Hospital Universitario de Móstoles
Móstoles, , Spain
Clínica Universidad de Navarra
Pamplona, , Spain
Hospital General de Segovia
Segovia, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Virgen de la Salud
Toledo, , Spain
Hospital Clínico Universitario
Valencia, , Spain
Consorcio H. General Universitario de Valencia
Valencia, , Spain
Hospital Universitari i Politècnic La Fe
Valencia, , Spain
Hospital Dr Peset
Valencia, , Spain
Hospital Lluís Alcanyís
Xàtiva, , Spain
Hospital Miguel Servet
Zaragoza, , Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
INC-ACO-2013-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.