Reversal of Dabigatran Anticoagulant Effect With Idarucizumab
Status: | Completed |
---|---|
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 1/7/2018 |
Start Date: | May 6, 2014 |
End Date: | October 20, 2016 |
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
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.
idarucizumab in patients treated with dabigatran etexilate who have uncontrolled bleeding or
require emergency surgery or procedures.
Inclusion criteria:
- 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.
Exclusion criteria:
- 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).
We found this trial at
31
sites
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Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Genesys Regional Medical Center Genesys Health System, a member of Ascension Health, is a group...
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Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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Newton-Wellesley Hospital A comprehensive medical center located right in Newton on Washington Street, Newton-Wellesley Hospital...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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