Introduction Hip fracture surgery is associated with high in-hospital and 30-day mortality rates and serious adverse patient outcomes. Evidence from randomised controlled trials regarding effectiveness of spinal versus general anaesthesia on patient-centred outcomes after hip fracture surgery is sparse.
Methods and analysis The iHOPE study is a pragmatic national, multicentre, randomised controlled, open-label clinical trial with a two-arm parallel group design. In total, 1032 patients with hip fracture (>65 years) will be randomised in an intended 1:1 allocation ratio to receive spinal anaesthesia (n=516) or general anaesthesia (n=516). Outcome assessment will occur in a blinded manner after hospital discharge and inhospital. The primary endpoint will be assessed by telephone interview and comprises the time to the first occurring event of the binary composite outcome of all-cause mortality or new-onset serious cardiac and pulmonary complications within 30 postoperative days. In-hospital secondary endpoints, assessed via in-person interviews and medical record review, include mortality, perioperative adverse events, delirium, satisfaction, walking independently, length of hospital stay and discharge destination. Telephone interviews will be performed for long-term endpoints (all-cause mortality, independence in walking, chronic pain, ability to return home cognitive function and overall health and disability) at postoperative day 30±3, 180±45 and 365±60.
Ethics and dissemination iHOPE has been approved by the leading Ethics Committee of the Medical Faculty of the RWTH Aachen University on 14 March 2018 (EK 022/18). Approval from all other involved local Ethical Committees was subsequently requested and obtained. Study started in April 2018 with a total recruitment period of 24 months. iHOPE will be disseminated via presentations at national and international scientific meetings or conferences and publication in peer-reviewed international scientific journals.
Trial registration number DRKS00013644; Pre-results
- geriatric medicine
- anaesthesia in orthopaedics
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Contributors MC is the iHOPE Study Director and Coordinating Principal Investigator. He conceived the overall study and received the iHOPE grant (01KG1714 from the Federal Ministry for Education and Research (BMBF), Bonn, Germany). The iHOPE Clinical Project Management is allocated to AK. AK wrote the first draft of this manuscript and made substantial contributions to the conception of the study protocol together with MC. The iHOPE Trial Management (MC, RR, SI, AH and MDN), the Trial Statistician (R-DH), the Data Monitoring and Safety Board (CN, TH, DH, MalB, MatB and RD), the investigators of the participating iHOPE centres (CA, JA, MD, PetK, PasK, PetK, RL-F, CO, CR, RS, CS, OV, FW, MW, KZ and AZ) and other participating bodies (FH, HS, MS, DCW, MK, FS, CB and RDS) each made substantial contributions to the conception or design of the study protocol. All authors revised the protocol critically for important intellectual content, approved the final version and agree to be accountable for all aspects of the work. The iHOPE study group is listed as Collaborators. The Collaborators are substantially involved in carrying out the iHOPE study as Investigators of the recruiting centres, in the project and data management and monitoring. All Collaborators critically reviewed the study protocol and the manuscript.
Funding This work was supported by the Federal Ministry for Education and Research (BMBF), Bonn, Germany (grant number 01KG1714).
Competing interests MC received a grant for this trial from the Federal Ministry for Education and Research (BMBF), Bonn, Germany. MDN is currently funded by the US Patient-Centered Outcomes Research Institute for related work (grant PCS 1406-18876), and he is the principal investigator of the REGAIN Trial (Clinicaltrials.gov number NCT02507505).
Patient consent Not required.
Ethics approval Ethical approval EK 022/18 was obtained from the leading Ethics Committee of the RWTH Aachen University on 14 March 2018. An approval from all other involved local ethical committees was subsequently requested.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators Anna B Roehl, Julia Van Waesberghe and Sebastian Ziemann, Department of Anaesthesiology, Medical Faculty RWTH Aachen University, Aachen, Germany. Christina Fitzner, Department of Medical Statistics, Medical Faculty RWTH Aachen University, Aachen, Germany. Joao Pedro Batista and Mathias Freitag, Department of Geriatric Medicine, Medical Faculty RWTH Aachen University, Aachen, Germany. Dr Claudia Dietrich, Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty RWTH Aachen University, Aachen, Germany. Christina Kalvelage and Christina Grohe, Center for Translational & Clinical Research Aachen (CTC-A), Medical Faculty RWTH Aachen University, Aachen, Germany. Alexander Schiemann and Katrin Schmidt, Department of Anaesthesiology, Charité Universitätsmedizin Berlin, Berlin, Germany. Dennis Reichert and Fenja Renziehausen, Department of Anaesthesiology, Gemeinschaftskrankenhaus Bonn, Bonn, Germany. Claudia Neumann, Department of Anaesthesiology and Operative Intensive Care Medicine, University Hospital Bonn, Bonn, Germany. Fenna Post and Maximilian Schäfer, Department of Anaesthesiology, University Hospital Düsseldorf, Düsseldorf, Germany. Thomas Müller and Anne Osmers, Department of Anaesthesiology and Intensive Care, University Hospital Dresden, Dresden, Germany. Jan Mersmann and Patrick Meybohm, Department of Anaesthesiology, Intensive Care and Pain Therapy, University Hospital Frankfurt, Frankfurt, Germany. Rainer Kiefmann and Ann-Kathrin Riegel, Department of the Geriatric Anaesthesiology, University Hospital Hamburg-Eppendorf, Hamburg, Germany. Wolfgang Koppert and Hans-Peter Reiffen, Department of Anaesthesiology and Intensive Care, Medical University Hannover, Hannover, Germany. Marion Ferner and Florian Heid, Department of Anaesthesiology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany. Mira Küllmar and Melanie Meersch, Department of Anaesthesiology, Intensive Care and Pain Therapy, University Hospital Muenster, Muenster, Germany. Bernhard Zwissler, Department of Anaesthesiology, Ludwig-Maximilian University (LMU) Munich, Munich, Germany. Hansjörg Haas and Agneta Peszko, Department of Anaesthesiology and Intensive Care, Reutlingen Hospital GMBH, Reutlingen, Germany. Christoph Ilies and Ulrich C Liener, Department of Anaesthesiology, Intensive Care and Pain Therapy, Marienhospital Stuttgart, Stuttgart, Germany. Carolin Maune and Stefanie Wehmeier Department of Anaesthesiology and Operative Intensive Care, University Witten/Herdecke. Tim Koke and Ingo Schwartges, Department of Anaesthesiology, Intensive Care and Pain Therapy, Klinikverbund St. Antonius und St. Josef GmbH, Wuppertal, Germany. Antonia Helf and Yvonne Jelting, Department of Anaesthesiology, University Hospital Würzburg, Würzburg, Germany.
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