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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT02319460
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years and older at admission for VKA-associated major bleeding
* A minimum of 365 days of continuous health plan enrollment before the index hospitalization involving acute VKA reversal treatment
* A minimum of 365 days of continuous pharmacy benefit before the index hospitalization involving acute VKA reversal treatment
Exclusion Criteria:
Patients will be excluded from the primary analyses if they:
* Require urgent reversal of VKA therapy in the setting of bleeding due to major trauma (eg, motor vehicle accident)
* Requiring urgent reversal of VKA therapy for a surgical procedure unrelated to major bleeding (eg, appendicitis)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02319460
Study Brief:
Protocol Section:
NCT02319460