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The trial objective is to demonstrate the safety of idarucizumab, as assessed by the occurence of patients with drug related adverse events (including immune reactions) and all-cause mortality in paediatric venous thromboembolism patients treated with dabigatran in ongoing clinical trials who require emergency surgery/urgent procedures or patients who have life-threatening or uncontrolled bleeding which requires urgent intervention, when rapid reversal of the anticoalugant effect of dabigatran is needed.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Not yet recruiting
Published on BioPortfolio: 2016-06-28T21:23:21-0400
The objective is to collect the safety data of idarucizumab for patients treated with dabigatran who require rapid reversal of the anticoagulant effects of dabigatran in cases of uncontrol...
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 r...
To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition
The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding ...
The Chongqing intracerebral hemorrhage study is a multi-center, prospective, observational study led by professor Qi Li from Chongqing Medical University. Professor Peng Xie will be the se...
Introduction - Among antidotes in development for reversal of novel oral anticoagulants, dabigatran-specific idarucizumab was the first one to reach the market. Case presentation - We present the firs...
Idarucizumab, a fully humanized Fab antibody fragment, is indicated for reversal of dabigatran's anticoagulant activity. Idarucizumab neutralizes the anticoagulant effects of dabigatran by binding to ...
82-year old male patient suspected of having cerebral hemorrhage under anticoagulation therapy with Dabigatran due to atrial fibrillation.
A Case of Successful Drug Management with Dabigatran and Idarucizumab to Address Embolic and Hemorrhagic Complications for Asymptomatic and Traumatic Subdural Hematoma with Non-valvular Atrial Fibrillation.
A 93-year-old woman incurred a head bruise 5 days prior to presentation, and head CT revealed right subacute subdural hematoma. As she was on direct oral anti-coagulant(DOAC)treatment for non-valvular...
: Bleeding is the main complication of anticoagulant treatments as dabigatran etexilate. In patients with atrial fibrillation, dabigatran, at certain doses, has been associated with similar rates of s...
Hemorrhage within the orbital cavity, posterior to the eyeball.
Intraocular hemorrhage from the vessels of various tissues of the eye.
Hemorrhage following any surgical procedure. It may be immediate or delayed and is not restricted to the surgical wound.
The sudden loss of blood supply to the PITUITARY GLAND, leading to tissue NECROSIS and loss of function (PANHYPOPITUITARISM). The most common cause is hemorrhage or INFARCTION of a PITUITARY ADENOMA. It can also result from acute hemorrhage into SELLA TURCICA due to HEAD TRAUMA; INTRACRANIAL HYPERTENSION; or other acute effects of central nervous system hemorrhage. Clinical signs include severe HEADACHE; HYPOTENSION; bilateral visual disturbances; UNCONSCIOUSNESS; and COMA.
Intracranial bleeding into the PUTAMEN, a BASAL GANGLIA nucleus. This is associated with HYPERTENSION and lipohyalinosis of small blood vessels in the putamen. Clinical manifestations vary with the size of hemorrhage, but include HEMIPARESIS; HEADACHE; and alterations of consciousness.
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...
Clinical trials are a set of procedures in medical research conducted to allow safety (or more specifically, information about adverse drug reactions and adverse effects of other treatments) and efficacy data to be collected for health interventions (e.g...