Kidney Cancer
Conditions
Keywords
nephrectomy, blood sparing, allogenic blood transfusion
Brief summary
The Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer Trial (RESTRICT). The primary objective is to reduce the number of units of allogenic blood transfusion in locally advanced kidney cancer (≥ cT2). Secondary objectives include reduction in perioperative complications, assessment of recurrence free-survival and improving overall survival.
Detailed description
The Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer Trial (RESTRICT) is a randomized study to investigate blood sparing using autologous normovolemic hemodilution (ANH) or cell salvage at the time of nephrectomy for locally advanced kidney cancer after assessing inclusion criteria patients will be randomized to undergo standard blood management including the possibility of allogenic transfusion vs autologous blood transfusion. There are multiple ways patients can receive allogenic or autologous blood, including veno-venous bypass or cardiopulmonary bypass (typically reserved for patients with a thrombus above the level of the hepatic veins or entering the heart).
Interventions
PROCEDUREBlood Sparing Protocol
Acute Normovolemic Hemodilution, Cell Saver, and/or Veno-venous Bypass
PROCEDUREStandard Blood Replacement
Allogenic blood transfusion as determined intra-operatively
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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: * Hemoglobin ≥ 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) ≤ 75U/L or total bilirubin ≤ 2.0 mg/dL. * WBC within institutional normal limits. * PT within institutional normal limits. * INR \< 1.5 and PTT normal. * Consent and compliance with all aspects of the study protocol.
Exclusion criteria
* Male and female younger than 18 years old. * Non-surgical candidate * Unstable angina.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of units of allogenic blood transfusions | Baseline to 30 days postoperatively | The primary goal of the study is to evaluate the impact of the blood sparing techniques on the reduction of allogenic blood transfusion in locally advanced kidney cancer. The total number of allogenic blood units used at the end of each case will be assessed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Complications | Baseline to 30 days and 90 days postoperatively | Number of complications will be assessed by Clavien-Dindo Index Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II Pharmacological treatment with drugs other than such allowed for grade I. Grade III Requiring surgical, endoscopic or radiological intervention * IIIa Not under general anesthesia * IIIb Under general anesthesia Grade IV Life-threatening complication (including CNS complications)\* requiring IC/ICU- management * IVa single organ dysfunction (including dialysis) * IVb multiorgan dysfunction Grade V Death |
| Grade of Complications | Baseline to 30 days and 90 days postoperatively | Grade of complications will be assessed by Clavien-Dindo Index Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II Pharmacological treatment with drugs other than such allowed for grade I. Grade III Requiring surgical, endoscopic or radiological intervention * IIIa Not under general anesthesia * IIIb Under general anesthesia Grade IV Life-threatening complication (including CNS complications)\* requiring IC/ICU- management * IVa single organ dysfunction (including dialysis) * IVb multiorgan dysfunction Grade V Death |
| Kidney Cancer Recurrence | Up to 3 years postoperatively | Assessment of recurrence of kidney cancer by radiographic imaging (CT or MRI) |
| Overall Survival | Up to 3 years postoperatively | Assessment of survival after surgery |
| Quality of life as measured by Functional Assessment of Cancer Therapy-Kidney Symptom Index (FSKI-19) | Pre-operative, 1 and 3 months postoperatively | Assessment of quality of life measures postoperatively, scores range from 0-76, with higher scores indicating worse symptoms Score range: 0-76 A score of 0 is a severely symptomatic patient and the highest possible score is an asymptomatic patient. |
Countries
United States
Outcome results
None listed