Metzger, Anja K.
Segal, Nicolas http://orcid.org/0000-0002-0715-9730
Olson, Dai Wai
Figueroa, Stephen A.
Sadaka, Farid G.
Krause, Catherine A.
Homuth, James R.
Burkhart, Nathaniel T.
Neumann, Robert T.
Lurie, Keith G.
Convertino, Victor A.
Article History
Received: 13 October 2017
Accepted: 20 May 2018
First Online: 26 June 2018
Ethics approval and consent to participate
: Due to the nature of this study involving patients with severe BI, it was anticipated that consent decisions would be obtained via a surrogate decision maker as permitted by US laws. This study was approved by local Institutional Review Boards (IRBs) at each site: University of Texas Southwestern Medical Center IRB (042013–045), Mercy Hospital St. Louis IRB (13–021), and University of Colorado Hospital (Aurora, CO) Colorado Multiple IRB (13–2436). The information collected about study patients was kept confidential by the sponsor and by research staff at the study site in accordance with the Federal Privacy Rule. The study ClinicalTrials.gov Identifier was NCT01824576.
: AKM, JRH, and NTB are employed by ZOLL, the manufacturer of the CirQlator device. KGL is the inventor of aIPR therapy and a consultant to ZOLL. The other authors declare that they have no competing interests.
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