ARCTIC-I Study Protocol v 2.0 dated 28 May 2021
ARCTIC-I
Dear investigator,
Thank you for your interest in the ARCTIC-I Study.
The study is now closed to recruitment.
The ARCTIC-I Study: An explanation by the Chief Investigator Dr. Andreas Ranft
Chief Investigator
Dr. Andreas Ranft (Klinik für Anaesthesiologie und Intensivmedizin, Technische Universität München, Germany)
Timeline
Recruitment of patients closed in 2023.
Additional Documents
ARCTIC-I Study Flyer V1.7, 05 Nov 2020
Steering Committee
- Dr. Andreas Ranft (Klinik für Anaesthesiologie und Intensivmedizin, Technische Universität München, Germany)
- Dr. Francesca Rapido (CHU Montpellier – Hôpital Gui de Chauliac, France)
- Dr. Nicolai Goettel (Brigham and Women’s Hospital, Harvard Medical School, Boston, MA, USA)
- Prof. Gerhard Schneider (Klinik für Anaesthesiologie und Intensivmedizin, Technische Universität München, Germany)
- Prof. Jens Meier (Kepler University Clinic, Austria)
- Dr. Alexander Hapfelmeier (Institut für Medizinische Informatik, Statistik und Epidemiologie, Technische Universität München, Germany)
Sponsor
The Study is entirely sponsored by a grant from the European Society of Anaesthesiology and Intensive Care Clinical Trial Network (ESAIC CTN). The ESAIC CTN provides an infrastructure for clinical research in the fields of Anaesthesia, Pain, Intensive Care and Emergency Medicine by transnational European collaborative studies.
Participating Countries
National Coordinator list
Country | Name | Institution |
Belgium | Dr. Dieter Mesotten | Ziekenhuis Oost-Limburg |
Croatia | Dr. Natasa Kovac | UHC ZAGREB |
Czech Republic | Dr. Ondřej Volný | University Hospital Ostrava |
Denmark | Dr. Christine Sølling | Rigshospitalet |
Egypt | Dr. Ahmed Awad | Ain-Shams university hospitals |
France | Dr. Francesca Rapido (Steering Committee) | CHU Montpellier |
Georgia | Dr. Tamar Macharadze | David Tvildiani Medical University |
Germany | Dr. Ana Kowark | University Hospital RWTH Aachen |
Greece | Dr. Amalia Douma | General Hospital of Athens |
Iraq | Dr. Hashim Talib Hashim | Baghdad Teaching Hospital |
Israel | Dr. Orit Nahtomi Shick | Shaare Zedek Medical Center |
Italy | Dr. Lorenzo Gamberini | Ospedale Maggiore Carlo Alberto Pizzardi |
Libya | Dr.Muhammed Elhadi | Ministry of Health, Tripoli |
Malaysia | Dr.Collins Chong | Hospital Pengajar Universiti Putra Malaysia |
Malta | Dr. Christabel Mizzi | Mater Dei Hospital |
Netherlands | Dr. Michiel Bos | Maastricht University Medical Center |
Portugal | Dr. Sergio Vide | Centro Hospitalar Universitário São João |
Russia | Dr. Nikolay Dovbysh & Dr.Alexey Gritsan | Krasnoyarsk Clinical Regional Hospital |
Serbia | Dr. Dragana Unic-Stojanovic | Institute for Cardiovascular Diseases Dedinje |
Slovenia | Prof. dr. Vesna Novak Jankovic | University Medical Centre Ljubljana |
Spain | Dr. Javier Silva García | Hospital Universitario 12 de Octubre |
Sudan | Dr. Hammad A. Fadlalmola | Soba University Hospital |
Tunisia | Dr. Mahmoud Marzouk | National Institute of Neurology Mongi Ben Hmida |
Turkey | Dr. Meltem Sarvan Karadeniz | Istanbul University |
UK | Dr. Naginder Singh | Queen Elizabeth Hospital Birmingham |
Ukraine | Dr. Dmytro Shchehlov | Scientific-Practical Centre Of Endovascular Neurosurgery NAMS of Ukraine |
United Arab Emirates | Prof. Massimo Lamperti | Cleveland Clinic Abu Dhabi |
US | Dr. Deepak Sharma | University of Washington, Seattle |
Protocol, Appendices and other Study Documents
Protocol & Appendices
ARCTIC-I Appendix 01-Protocol Synopsis V2.0 28MAY 2021
ARCTIC-I Appendix 02-Timeline V2.0 28 MAY 2021
ARCTIC-I Appendix 03 – Pre-Study Survey – V1.1 Dated 02 Feb 2021
ARCTIC-I Appendix 04 – Approval Documentation Coversheet – V 1.0 Date 08 October 2020
ARCTIC-I Appendix 05 – Task delegation form – V 1.0 Dated 08 October 2020
ARCTIC-I Appendix 07 – Screening List – V 1.0 Dated 08 October 2020
ARCTIC-I Appendix 08- Confidential Patient Logsheet – V 1.0 Dated 08 October 2020
ARCTIC-I Appendix 9A – Patient ID Coversheet – V 1.0 Dated 08 October 2020
ARCTIC-I App. 9B – DCF V 3.0, 2022 Jan 27
ARCTIC-I Appendix 10 Glossary V2.0 28 MAY 2021
ARCTIC-I Appendix 11- End of study Reporting Form – V 1.0 Dated 08 October 2020
Support document
ARCTIC-I FU, telephone script 2021 Oct 05
ARCTIC-I Study Flyer V1.7, 05 Nov 2020
ARCTIC-I Case Report Form Completion Guidelines Final
ARCTIC-I SAP 2022-02-22
ARCTIC-I FAQ 15SEP2022
Validated Patient Documents and Translations
Belgium
ARCTIC-I Appendix 06B2 Consent – Patient Information sheet and IC _DU
ARCTIC-I Appendix 06B2 Consent – Patient Information sheet and IC -FR
Croatia
ARCTIC-I Appendix 06B2 Consent – Patient Information sheet and IC (V 2.0 of 17 December 2020)
ARCTIC-I Appendix 06C2 Consent – Legal representative’s Information sheet and IC V 2.1
Czech Republic
ARCTIC-I Appendix 01-Protocol Synopsis V2.0 28MAY 2021
ARCTIC-I Appendix 06B2 Consent – Patient Information sheet and IC (V 2.0 of 17 December 2020)
ARCTIC-I Appendix 06C2 Consent – Legal representative’s Information sheet and IC V 2.1
Egypt
ARCTIC-I Appendix 06B1 Leg. Int. – Patient Information sheet and Consent v2.0 (17DEC2020)
ARCTIC-I Appendix 06C1 Leg. Int. – Patient Information sheet and Consent – Legal representative v2.0 (17DEC2020)
France
ARCTIC-I Appendix 01 Protocol Synopsis V 2.0 28 May 2021
ARCTIC-I Appendix 06A-Patient Information Sheet (V 2.0 of 17 December).
Georgia
ARCTIC-I Appendix 06B2 -Patient Information sheet and IC (V 2.0 of 17 December 2020)
ARCTIC-I Appendix 06C2 Consent– Legal representative’s Information sheet and IC
Greece
ARCTIC-I Appendix 06B2 Consent – Patient Information sheet and IC (V 2.0 of 17 December 2020)
ARCTIC-I Appendix 06C2 Consent – Legal representative’s Information sheet and IC V 2.1
Israel
ARCTIC-I Appendix 06A-Patient Information Sheet -V 2.0 of 17 December
Italy
ARCTIC-I Appendix 01 – Protocol Synopsis V2.0 Validated 16June2021
ARCTIC-I Appendix 06B2 Consent – Patient Information sheet and IC (V 2.0 of 17 December 2020)
ARCTIC-I Appendix 06C2 Consent– Legal representative’s Information sheet and IC
ARCTIC-I Appendix 06D2 Consent – Patient Information sheet and retroactive IC (V 2.0 of 17 December 2020)
Malaysia
ARCTIC-I Appendix 06B1 Leg. Int. – Patient Information sheet and Consent v2.0 (17DEC2020)
ARCTIC-I Appendix 06C1 Leg. Int. – Patient Information sheet and Consent – Legal representative v2.0 (17DEC2020)
Malta
ARCTIC-I Appendix 06B2 Consent – Patient Information sheet and IC (V 2.0 of 17 December 2020)
ARCTIC-I Appendix 06C2 Consent – Legal representative’s Information sheet and IC V 2.1
Netherlands
ARCTIC-I Appendix 06B2 Consent – Patient Information sheet and IC (V 2.0 of 17 December 2020)
ARCTIC-I Appendix 06C2 Consent – Legal representative’s Information sheet and IC V 2.1
Portugal
ARCTIC-I Appendix 06B2 -Patient Information sheet and IC (V 2.0 of 17 December 2020)
ARCTIC-I Appendix 06C2 Consent– Legal representative’s Information sheet and IC (V 2.0 of 17 December2020)
Russia
ARCTIC-I Appendix 06B2 -Patient Information sheet and IC (V 2.0 of 17 December 2020)
ARCTIC-I Appendix 06C2 Consent – Legal representative’s Information sheet and IC V2.1
Slovenia
ARCTIC-I Appendix 06B2 -Patient Information sheet and IC (V 2.0 of 17 December 2020)
ARCTIC-I Appendix 06С2 Consent – Legal representative’s Information sheet and IC, 2.0 dated 17 Dec 2020
Spain
ARCTIC-I Appendix 06B2 -Patient Information sheet and IC (V 2.0 of 17 December 2020)
ARCTIC-I Appendix 06C2 Consent– Legal representative’s Information sheet and IC V2.1
ARCTIC-I Appendix 06D2 -Patient Information sheet and IC (V 2.0 of 17 December 2020)
Sudan
ARCTIC-I Appendix 06B1 Leg. Int. – Patient Information sheet and Consent v2.0 (17DEC2020)
ARCTIC-I Appendix 06C1 Leg. Int. – Patient Information sheet and Consent – Legal representative v2.0 (17DEC2020)
Tunisia
ARCTIC-I Appendix 06B1 Leg. Int. – Patient Information sheet and Consent v2.0 (17DEC2020)
ARCTIC-I Appendix 06C1 Leg. Int. – Patient Information sheet and Consent – Legal representative v2.0 (17DEC2020)
Turkey
ARCTIC-I Appendix 06B2 Consent – Patient Information sheet and IC (V 2.0 of 17 December 2020)
ARCTIC-I Appendix 06C2 Consent– Legal representative’s Information sheet and IC (V 2.1 of 17 December2020)
Ukraine
ARCTIC-I Appendix 01- Protocol Synopsis – ARCTIC-I Study Protocol v 2.0 dated 28 May 2021
ARCTIC-I Appendix 06B2 -Patient Information sheet and IC (V 2.0 of 17 December 2020)
ARCTIC-I Appendix 06C2 Conse nt Legal representatives Information sheet and IC (V 2.0 of 17 December 2020)
Endorsements
SIAARTI: Italian Society of Anaesthesiology, Analgesia, Reanimation and Intensive Care
Italy
Support
ARCTIC-I Study is proud to announce its support by :