Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02831660
Eligibility Criteria:
Inclusion criteria:
* Currently taking dabigatran etexilate.
* Age \>= 20 years at entry.
* Written Informed consent
* Group A:
\-- Uncontrolled or life-threatening judged by the physician to require a reversal agent.
* Group B:
* A condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
Exclusion criteria:
* Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).
* Group A:
* Patients with minor bleeding (e.g. epistaxis, hematuria) who can be managed with standard supportive care.
* Patients with no clinical signs of bleeding.
* Group B:
* surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT02831660
Study Brief:
Protocol Section:
NCT02831660