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Reversal Dabigatran Anticoagulant Effect With Idarucizumab

2016-06-28 21:23:21 | BioPortfolio

Summary

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hemorrhage

Intervention

Idarucizumab

Status

Not yet recruiting

Source

Boehringer Ingelheim

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-28T21:23:21-0400

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This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding

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Chongqing Intracerebral Hemorrhage Study

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PubMed Articles [736 Associated PubMed Articles listed on BioPortfolio]

Administration of idarucizumab in spontaneous intracerebral hemorrhage under dabigatran-therapy.

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Assessment of patients post reversal with idarucizumab.

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 ...

The use of Idarucizumab in intracerebral bleeding - a case report.

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Medical and Biotech [MESH] Definitions

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.

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