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.

Boehringer Ingelheim bv0 个研究点目标入组 500 人开始时间: 2014年3月20日最近更新: 2017年1月9日

适应症

试验速览

暂无简介。

•- 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 procedure where adequate hemostasis is required. Emergency is defined as within the next 4 hours.
•-- Current treatment with dabigatran
•-- At least 18 years of age
•-- Writen Informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 475

•- 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 hypersensitiity to the drug or its excipients.

发起方

Boehringer Ingelheim bv