A Phase III Case Series Clinical Study of the Reversal of the Anticoagulant Effects of Dabigatran by Intravenous Administration of 5.0g Idarucizumab (BI 655075) in Patients Treated Wtih Dabigatran Etexilate Who Have Uncontrolled Bleeding or Require Emergency Surgery or Procedures.RE-VERSE AD (A Study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) Trial

CompletadoFase 3ClinicalTrials.gov

ID: NCT02104947Tipo: INTERVENTIONALInicio: 6 de may de 2014Fin estimado: 20 de oct de 2016

Traducción no disponible, mostrando original

Resumen

Evaluate the reversal of the anticoagulant effects of dabigatran by IV administration of 5.0g idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Group A (Bleeding patients)
Overt bleeding judged by the physician to require a reversal agent
Currently taking dabigatran etexilate
At least 18 years of age
Written informed consent
Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or procedure for a condition other than bleeding
Condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
Current treatment with dabigatran
At least 18 years of age
Written Informed consent.

Criterios de exclusión

Group A (Bleeding Patients)
Patients with minor bleeds (epistaxis, hematuria) who can be managed with standard supportive care.
Patients with no clinical signs of bleeding
Contraindications to study medication including known hypersensitivity to the drug or its excipients.
Group B (Patients who require emergency surgery or procedure)
A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

Intervenciones

drug

idarucizumab

Ubicaciones

Centro Privado de Cardiología

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalBoehringer Ingelheim

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Phase III Case Series Clinical Study of the Reversal of... | EligiMed