Baksaas-Aasen, K.
Gall, L. S.
Stensballe, J.
Juffermans, N. P.
Curry, N.
Maegele, M.
Brooks, A.
Rourke, C.
Gillespie, S.
Murphy, J.
Maroni, R.
Vulliamy, P.
Henriksen, H. H.
Pedersen, K. Holst
Kolstadbraaten, K. M.
Wirtz, M. R.
Kleinveld, D. J. B.
Schäfer, N.
Chinna, S.
Davenport, R. A.
Naess, P. A.
Goslings, J. C.
Eaglestone, S.
Stanworth, S.
Johansson, P. I.
Gaarder, C.
Brohi, K.
Funding for this research was provided by:
Seventh Framework Programme (F3-2013-602771)
Article History
Received: 16 February 2020
Accepted: 20 September 2020
First Online: 13 October 2020
Compliance with ethical standards
:
: K.Baksaas-Aasen, L.S.Gall, J.Stensballe, N.P.Juffermans, N.Curry, C.Rourke, S.Gillespie, J.Murphy, R.Maroni, P.Vulliamy, H.H.Henriksen, K.Holst Pedersen, K.M. Kolstadbraaten, M.R.Wirtz, D.J.B. Kleinveld, N.Schäfer, S.Chinna, P.A.Naess, J.C.Goslings, S.Eaglestone and S.Stanworth declare no conflicts of interest. M.Maegele has received honoraria for lectures and speakers’ bureaus, congress travel support as well as financial support for research projects from Astra Zeneca, Bayer, CSL Behring, IL-Werfen/TEM International, LFB Biomedicaments and Portola Inc. A. Brooks has received a research grant from Haemonetics Corp. in the form of cartridges and reagent support. He has also served on advisory panel for Haemonetics Corp. and TEM International and received honoraria for education lectures for Johnson and Johnson. P.I. Johansson´s has received unrestricted research grants from Haemonetics Corp. and Octapharma AG. C.Gaarder has received honoraria for lectures from Octapharma and research grant support from Haemonetics and TEM International in the form of device and reagent support. She has also previously served on the advisory board for Nycomed. K.Brohi and R.Davenport have received research grant support from TEM International in the form of device and reagent support. K.Brohi has previously served on external advisory panels for Haemonetics Corp, TEM International, CSL Behring, Bayer and Astra Zeneca.
: The study was designed by the authors, and the design was approved by the trial sponsor (Queen Mary University of London) and the national research ethics committees of participating institutions. The study was in accordance with the 1964 Helsinki Declaration.
: Initial enrolment in the trial was provided on behalf of incapacitated patients by a personal or nominated consultee until the patient regained the physical and mental capacity to provide such consent.
: De-identified individual participant data underlying primary and secondary endpoints will be available on request from researchers, after approval of proposal. Study protocol and statistical analysis plan are presented in the Supplementary Materials, and informed consent form will be shared, if requested. The data will be available by contacting the corresponding author after publication.