Bradshaw, Paige Garber http://orcid.org/0000-0002-8030-7269
Keegan, Shaun
Foertsch, Madeline
Yang, George L.
Ngwenya, Laura B.
Srinivasan, Vasisht
Article History
Accepted: 6 April 2022
First Online: 4 May 2022
Declarations
:
: All authors have no conflicts of interests to disclose regarding participation in this project.
: IRB approval was obtained for ongoing analysis of andexanet alfa outcomes in ICH patients at University of Cincinnati Medical Center with waived patient consent due to retrospective research design. Collection of data may be used to generate hypotheses and observations that would lead to or validate a prospective clinical study, lead to clinical trial design, or adapt institutional treatment guidelines. Additionally, collected data under current IRB approval is used to generate metrics affiliated with quality improvement by allowing detailed post-hoc analysis of clinical and physiologic variables of patients who received andexanet alfa. Because the review will involve records several years remote, it is not felt to be feasible to obtain informed consent. This study involves reviewing medical documents and images. The risk of participation to the subjects is judged to be minimal and only related to the potential disclosure of protected health information – to which appropriate precautions have taken place with deidentification and secure data storage. Per University of Cincinnati IRB, removal of the consent process is judged not to adversely affect the participants’ rights and welfare beyond exposure to no more than minimum risk. No imaging will be included or presented in current case series.