NCT04922307 (RESTRICT).

Study name	RESTRICT
Methods	Adult participants aged over 18 years undergoing radical nephrectomy for locally advanced kidney cancer will be randomised to one of two groups. The method of randomisation and allocation concealment is not described. The study will be single‐blinded (participant).
Participants	Adult participants aged over 18 years undergoing radical nephrectomy for locally advanced kidney cancer will be randomly allocated to one of two groups. The estimated enrolment number is 240. Experimental group (blood‐sparing protocol) (Autotransfusion group): N = 120 Active comparator group (standard blood replacement) (Control group): N = 120 Inclusion criteria Renal masses ≥ cT2 (by any conventional imaging) N1 or M1 disease is allowed if they are deemed surgical candidates (including cytoreductive nephrectomy) Male and female patients 18 and older Ejection fraction (EF) ≥ 45% by echocardiogram (ECHO) Adequate organ function as defined by: Haemoglobin ≥ 9 g/dL. Pre‐operative allogenic blood transfusion is allowed Platelets ≥ 100.000/μl Albumin ≥ 2.5 g/dL Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 75 U/L or total bilirubin ≤ 2.0 mg/dL White blood cell (WBC) within institutional normal limits Prothrombin time (PT) within institutional normal limits International normalised ratio (INR) < 1.5 and partial thromboplastin time (PTT) normal Consent and compliance with all aspects of the study protocol Exclusion criteria Males and females younger than 18 years Non‐surgical candidate Unstable angina
Interventions	Experimental group (blood‐sparing protocol) (Autotransfusion group): the intervention group will undergo radical nephrectomy with blood‐sparing techniques. Blood‐sparing techniques will include acute normovolaemic haemodilution (ANH), Cell Saver (intraoperative) and/or veno‐venous bypass. Active comparator group (standard blood replacement) (Control group): the control group will undergo radical nephrectomy without blood‐sparing techniques (i.e. standard care). Participants who need blood transfusion will received cross‐matched allogeneic blood products.
Outcomes	Number of units of allogeneic blood transfusions, number of complications, grade of complications, kidney cancer recurrence, overall survival, quality of life (Functional Assessment of Cancer Therapy‐Kidney Symptom Index (FSKI‐19))
Starting date	10 June 2021 Estimated primary completion date: 15 June 2024 Estimated study completion date: 15 June 2026
Contact information	Principal Investigator: Kelvin Moses, Vanderbilt University Medical Center No contact information provided
Notes	Transfusion protocol: use of a transfusion protocol is not reported Prospective registration status: study was prospectively registered on ClinicalTrials.gov (date of registration: 10 June 2021) Ethical approval: not known whether the study has been approved by an ethics committee or institutional review board Language: information available on ClinicalTrials.gov is in English Status: Last update posted: 31 August 2022 Recruitment status: suspended (funding)