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Ensayo en fase III, multicéntrico, prospectivo, aleatorizado, abierto, secuencial por grupos adaptativos con evaluación ciega de los criterios de valoración para evaluar la eficacia y la seguridad de PROTHROMPLEX TOTAL en la neutralización de la anticoagulación causada por los inhibidores del factor Xa por vía oral directa en pacientes que requieren cirugía urgente o una intervención invasiva.

Ensayo en fase III, multicéntrico, prospectivo, aleatorizado, abierto, secuencial por grupos adaptativos con evaluación ciega de los criterios de valoración para evaluar la eficacia y la seguridad de PROTHROMPLEX TOTAL en la neutralización de la anticoagulación causada por los inhibidores del factor Xa por vía oral directa en pacientes que requieren cirugía urgente o una intervención invasiva.

Datos básicos

Código:: TAK-330-3001
Protocolo:: TAK-330-3001
EUDRACT:: 2021-004138-12
NCT:
Centro:: HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Dotación:
Año de incio:: 2022
Año de finalización:

ENSAYO CLÍNICO

Objetivos del proyecto

Objetivo Principal: Evaluar la eficacia intraoperatoria de PROTHROMPLEX TOTAL en comparación con el concentrado de complejo protrombínico de 4 factores (CCP-4F) estándar para la reversión de la anticoagulación en pacientes que reciben inhibidores orales directos del factor Xa y que requieren una intervención quirúrgica urgente o invasiva en las 15 horas siguientes a la última dosis del inhibidor del factor Xa. Objetivos Secundarios: Evaluar la seguridad y la eficacia postoperatoria de PROTHROMPLEX TOTAL en comparación con el CCP-4F estándar para la reversión de la anticoagulación en pacientes que reciben inhibidores orales directos del factor Xa y que requieren una intervención quirúrgica o invasiva urgente en las 15 horas siguientes a la última dosis del inhibidor del factor Xa.

Documentos

No hay documentos

Participantes

Oscar Fuster Lluch

Investigador Colaborador
María Pilar Argente Navarro

Investigador Colaborador
José Luis Poveda Andrés

Investigador Colaborador
Guido Mazzinari

Investigador Colaborador
Óscar Díaz Cambronero

Investigador Principal
María Vila Montañés

Investigador Colaborador
María José Alberola Estellés

Investigador Colaborador
Nuria García Gregorio

Investigador Colaborador
Valentín Arana Lozano

Investigador Colaborador
Maria Teresa Contreras Martinez

Investigador Colaborador
Laura Bruno Carlos

Investigador Colaborador
Ana Isabel Marqués Marí

Data Manager / Study Coordinator
Marysol Echeverri Vélez

Investigador Colaborador
Maria De Los Desamparados Beltall Olmos

Investigador Colaborador
Raquel Martin Monllor

Data Manager / Study Coordinator
Aitor Navarro Díaz

Data Manager / Study Coordinator
Isabel Molina Monleón

Investigador Colaborador

Ver todos los Investigadores

Grupos

Farmacogenética

Investigador Principal

María José Herrero Cervera
Medicina Perioperatoria, Anestesiología y Reanimación

Leader

Óscar Díaz Cambronero
Unidad de Descubrimiento de Fármacos (UDF)

Investigador Principal

Leonor Puchades Carrasco
Grupo de Investigación de Farmacia

Investigador Principal

Javier García Pellicer

Financiadores - Promotores

Takeda Development Center Americas (TDCA)

Resultados del Ensayo Clínico

Publicaciones en Revistas 69

[Translated article] Pharmacokinetic-guided switching from standard half-life factor VIII to extended half-life pegylated factor VIII in haemophilia A therapy in clinical practice.

Chovi-Trull, Maria; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.12.007. 2025

[Translated article] Real-world effectiveness and safety of nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma.

Fernandez, Laura Lorente; (...); Andres, Jose Luis Poveda

Article. 10.1016/j.farma.2024.09.006. 2024

Advanced Respiratory Monitoring in the Perioperative Setting

Jimenez-Santana, Jose Daniel; (...); Mazzinari, Guido

Review. 10.1007/s40140-024-00646-9. 2024

An educational intervention to reduce the incidence of postoperative residual curarisation: a cluster randomised crossover trial in patients undergoing general anaesthesia.

Diaz-Cambronero, Oscar; (...); Argente Navarro, Maria P

Article. 10.1016/j.bja.2023.02.031. 2023

An Individualized Low-Pneumoperitoneum-Pressure Strategy May Prevent a Reduction in Liver Perfusion during Colorectal Laparoscopic Surgery.

Olmedilla Arnal, Luis Enrique; (...); On Behalf Of The IPPColLapSe Ii Investigators

Article. 10.3390/biomedicines11030891. 2023

Assessing the relative efficacy of components of opioid-free anaesthesia in adult surgical patients: protocol for a systematic review and component network meta-analysis.

Belltall A; (...); Hollmann MW

Article. 10.1136/bmjopen-2024-089024. 2024

Assessing the value of moderate-to-severe atopic dermatitis treatment using multi-criteria decision analysis (MCDA).

Pereyra-Rodríguez JJ; (...); Ortiz de Frutos FJ

Letter. 10.1111/jdv.19432. 2023

Bronchial Blocker for Lung Isolation Onhemothorax Secondary to Maxillofacial Surgery

Tirados Bueno, Juan Francisco; (...); Moreno Puigdollers, Ignacio

Meeting Abstract. 2024

Comparative Temporal Analysis of Morbidity and Early Mortality in Heart Transplantation with Extracorporeal Membrane Oxygenation Support: Exploring Trends over Time

Lopez-Vilella, Raquel; (...); Bonet, Luis Almenar

Article. 10.3390/biomedicines12092109. 2024

Confirmatory study of the usefulness of quantum molecular resonance and microdissectomy for the treatment of lumbar radiculopathy in a prospective cohort at 6 months follow-up

Canos-Verdecho, Angeles; (...); Morales-Suarez-Varela, Maria

Article. 10.1515/sjpain-2023-0077. 2024

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano JB; (...); Soto-Ortega I

Article. 10.1016/j.farma.2023.01.003. 2023

Consensus recommendations for the improvement of inter- and intra-centre care coordination in the management of hemophilia.

Montoro-Ronsano, Jose Bruno; (...); Soto-Ortega, Inmaculada

Article. 10.1016/j.farma.2023.04.002. 2023

COST-EFFECTIVENESS ANALYSIS OF DIFELIKEFALIN FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE ASSOCIATED-PRURITUS IN SPAIN

Sanchez-Alvarez, Emilio E.; (...); Hernaez Colque, M.

Meeting Abstract. 2024

Current Concepts in Intraoperative Ventilation during Anesthesia for Laparoscopic and Robot-Assisted Surgery - a Narrative Review

Jimenez-Santana, Jose Daniel; (...); Mazzinari, Guido

Review. 10.1007/s40140-024-00648-7. 2024

Cybersecurity, a priority for pharmacy services in the age of artificial intelligence.

Hernández Marín CM, Monte-Boquet E, Poveda Andrés JL

Editorial Material. 10.1016/j.farma.2024.08.001. 2024

Determining value in the treatment of activated PI3Kdelta syndrome in Spain: a multicriteria decision analysis from the perspective of key stakeholders.

Abad, Maria Reyes; (...); Gil, Alicia

Article. 10.33393/grhta.2024.3041. 2024

Determining what represents value in the treatment of prurigo nodularis and its key unmet needs in Spain through Multi-Criteria Decision Analysis

Silvestre, Juan Francisco; (...); Serra-Baldrich, Esther

Article. 10.1002/jvc2.275. 2024

Effect of intraoperative PEEP with recruitment maneuvers on the occurrence of postoperative pulmonary complications during general anesthesia--protocol for Bayesian analysis of three randomized clinical trials of intraoperative ventilation.

Mazzinari G; (...); Serpa Neto A

Article. 10.12688/f1000research.125861.1. 2023

Effects of Spinal Cord Stimulation in Patients with Small Fiber and Associated Comorbidities from Neuropathy After Multiple Etiologies

Canos-Verdecho, Angeles; (...); Morales-Suarez-Varela, Maria

Article. 10.3390/jcm14020652. 2025

Efficacy of pulsed radiofrequency on the suprascapular and axillary-circumflex nerve for shoulder pain: A randomised controlled trial

Minana, Jose Miguel Esparza; (...); Cerda-Olmedo, German

Article. 10.4103/ija.ija_1107_23. 2024

Estimation of the difference between peritoneal microenvironment and core body temperature during laparoscopic surgery - a prospective observational study

Mazzinari, Guido; (...); Diaz-Cambronero, Oscar

Article. 10.1038/s41598-024-71611-z. 2024

Genetic Variants Associated with Biological Treatment Response in Inflammatory Bowel Disease: A Systematic Review.

Plaza J; (...); Moret-Tatay I

Article. 10.3390/ijms25073717. 2024

Helmet versus facemask CPAP in COVID-19 respiratory failure: a prospective cohort study.

Colaianni-Alfonso, Nicolas; (...); Grieco, Domenico Luca

Article. 10.1016/j.chest.2022.08.2221. 2022

High PEEP with recruitment maneuvers versus Low PEEP During General Anesthesia for Surgery - a Bayesian individual patient data meta-analysis of three randomized clinical trials.

Mazzinari, Guido; (...); Serpa Neto, Ary

Article. 10.1097/ALN.0000000000005170. 2025

How can artificial intelligence optimize value-based contracting?

Poveda, Jose Luis; (...); Medrano, Ignacio H.

Letter. 10.1186/s40545-022-00475-3. 2022

Impact of neuromuscular block monitoring and reversal on postoperative pulmonary complications in thoracic surgery: a Bayesian analysis of the iPROVE-OLV trial.

Mazzinari, Guido; (...); Ferrando, Carlos

Article. 10.1016/j.bja.2024.11.041. 2025

Impact of Standard Versus Low Pneumoperitoneum Pressure on Peritoneal Environment in Laparoscopic Cholecystectomy. Randomized Clinical Trial.

Serrano, Ana Belen; (...); Sanjuanbenito, Alfonso

Article. 10.1097/SLE.0000000000001244. 2024

Is erenumab an efficient alternative for the prevention of episodic and chronic migraine in Spain? Results of a cost-effectiveness analysis.

Pozo-Rosich P; (...); Irimia P

Article. 10.1186/s10194-024-01747-w. 2024

Isavuconazole Pharmacokinetics in Critically Ill Patients: Relationship with Clinical Effectiveness and Patient Safety.

Martin-Cerezuela, Maria; (...); Ramirez Galleymore, Paula

Article. 10.3390/antibiotics13080706. 2024

Left side clot in transit in double-lung transplantation diagnosticated by transesophageal echocardiography: What's next?

Perez-Ajami, D.; (...); Navarro, E. Viscasillas

Article. 10.1016/j.redar.2023.03.006. 2024

Low intra-abdominal pressure in laparoscopic surgery: a systematic review and meta-analysis.

Reijnders-Boerboom GTJA; (...); Warlé MC

Article. 10.1097/JS9.0000000000000289. 2023

Manipulación de fármacos para su administración por gastrostomía endoscópica percutánea en pacientes con esclerosis lateral amiotrófica y nutrición enteral.

Vázquez Polo A; (...); Vázquez Costa JF

Article. 10.20960/nh.03946. 2022

Observational study to evaluate discontinuation of monotherapy with cobicistat-boosted darunavir in patients with human immunodeficiency virus

Solana-Altabella, Antonio; (...); Poveda-Andres, Jose Luis

Article. 10.1097/MD.0000000000032208. 2022

ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain.

Poveda JL; (...); Badia X

Article. 10.1186/s13023-022-02610-4. 2023

Off-Pump Coronary Artery Bypass Grafting and Transaxillary Aortic Valve Implantation in Porcelain Aorta Through Minimally Invasive Cardiac Surgery

Sole Sabau, Miguel; (...); Argente Navarro, Maria Pilar

Meeting Abstract. 2024

Omics-Based Approaches for the Characterization of Pompe Disease Metabolic Phenotypes

Gomez-Cebrian, Nuria; (...); Puchades-Carrasco, Leonor

Review. 10.3390/biology12091159. 2023

OPTIMIZING MANAGEMENT AND OUTCOMES OF ACTIVATED PHOSPHOINOSITIDE 3-KINASE DELTA SYNDROME (APDS) IN SPAIN: BEWAYAPDS PROJECT

Flores-Moreno, S.; (...); Gil, A.

Meeting Abstract. 2024

Pericardial Effusion After Percutaneous Closure of the Left Atrial Appendage

Gallego Goyanes, Alejandro; (...); Argente Navarro, Pilar

Meeting Abstract. 2024

Perioperative Immunosuppressive Factors during Cancer Surgery: An Updated Review

Bezu, Lucillia; (...); Smith, Laura

Review. 10.3390/cancers16132304. 2024

Perioperative neuromuscular blockade. 2020 update of the SEDAR (Sociedad Espanola de Anestesiologia y Reanimacion) recommendations

Diaz-Cambronero, O.; (...); Oyonarte, C. L. Errando

Editorial Material. 10.1016/j.redar.2022.02.005. 2023

Perioperative neuromuscular blockade. 2020 update of the SEDAR (Sociedad Española de Anestesiología y Reanimación) recommendations.

Diaz-Cambronero, O; (...); Errando Oyonarte, C L

Practice Guideline. 10.1016/j.redare.2022.02.005. 2023

Pharmacogenetics in Response to Biological Agents in Inflammatory Bowel Disease: A Systematic Review.

Ballesta-Lopez, Octavio; (...); Poveda-Andres, Jose Luis

Article. 10.3390/ijms26041760. 2025

Physical and Quality of Life Changes in Elderly Patients after Laparoscopic Surgery for Colorectal Cancer-A Prospective Cohort Study

Mey, Rochelle; (...); Calatayud, Joaquin

Article. 10.3390/ijerph192214711. 2022

Quality of Recovery and Innate Immune Homeostasis in Patients Undergoing Low- Versus Standard pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery (RECOVER): A Randomized Controlled Trial.

Albers, I, Kim; (...); Warle, Michiel C.

Article. 10.1097/SLA.0000000000005491. 2022

Quantum Molecular Resonance Radiofrequency Disc Decompression and Percutaneous Microdiscectomy for Lumbar Radiculopathy

Canos-Verdecho, Angeles; (...); Morales-Suarez-Varela, Maria

Article. 10.3390/jcm13010234. 2024

Rationale and study design for an Individualized PeriopeRative Open lung VEntilatory approach in Emergency Abdominal Laparotomy/scopy: study protocol for a prospective international randomized controlled trial

Laguna, G.; (...); Ferrando, C.

Article. 10.1016/j.redar.2023.11.003. 2024

Rationale and study design for an Individualized PeriopeRative Open lung VEntilatory approach in Emergency Abdominal Laparotomy/scopy: study protocol for a prospective international randomized controlled trial.

Laguna G; (...); Ferrando C

Article. 10.1016/j.redare.2024.04.007. 2024

Risk factors for PPCs in laparoscopic non-robotic vs laparoscopic robotic abdominal surgery (LapRas): Rationale and protocol for a patient-level analysis of LAS VEGAS and AVATaR

Serafini, S. C.; (...); Ball, L.

Article. 10.1016/j.redar.2024.01.008. 2024

Risk factors for PPCs in laparoscopic non-robotic vs. laparoscopic robotic abdominal surgery (LapRas): rationale and protocol for a patient-level analysis of LAS VEGAS and AVATaR.

Serafini, S C; (...); Ball, L

Article. 10.1016/j.redare.2024.07.001. 2024

The association of salivary caffeine levels with serum concentrations in premature infants with apnea of prematurity

Garcia-Robles, Ana; (...); Saenz Gonzalez, Pilar

Article. 10.1007/s00431-022-04628-z. 2022

The Impact of Perioperative Anaesthesia Management on Cancer Recurrence.

Diaz-Cambronero, Oscar, Argente Navarro, Pilar

Article. 10.5152/TJAR.2022.22176. 2022

The RALE Score Versus the CT Severity Score in Invasively Ventilated COVID-19 Patients-A Retrospective Study Comparing Their Prognostic Capacities.

Valk, Christel M.; (...); Pisani, Luigi

Article. 10.3390/diagnostics12092072. 2022

The value of the reflective discussion in decision-making using multi-criteria decision analysis (MCDA): an example of determining the value contribution of tabelecleucel for the treatment of the Epstein Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD).

Badia, Xavier; (...); Valles, Joan-Antoni

Article. 10.1186/s13023-024-03324-5. 2024

VALUE CRITERIA FOR OUTCOMES BASED MANAGED ENTRY AGREEMENT OF CAR-T IN RELAPSED OR REFRACTORY MULTIPLE MYELOMA (RRMM) THROUGH MCDA

Poveda, J. L.; (...); Lizan, L.

Meeting Abstract. 2023

Win Ratio approach for the composite outcome of postoperative pulmonary complications: Secondary analysis of a harmonised and pooled database of three randomised clinical trials.

Serpa Neto, Ary; (...); Schultz, Marcus J

Article. 10.1097/EJA.0000000000002116. 2024

Datos básicos

Objetivos del proyecto

Documentos

Participantes

Grupos

Financiadores - Promotores

Resultados del Ensayo Clínico

Campos de estudio

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