Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer
- Conditions
- Kidney Cancer
- Interventions
- Procedure: Standard Blood ReplacementProcedure: Blood Sparing Protocol
- Registration Number
- NCT04922307
- Lead Sponsor
- Vanderbilt University Medical Center
- 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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 240
-
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.
- Male and female younger than 18 years old.
- Non-surgical candidate
- Unstable angina.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard Blood Replacement Standard Blood Replacement The control group of one hundred and twenty (120) patients will undergo radical nephrectomy without blood sparing techniques (ie. Standard of care). Patients who need blood transfusion will receive cross-matched allogenic blood products. Blood Sparing Protocol Blood Sparing Protocol The intervention group (120 patients) will undergo radical nephrectomy with blood-sparing techniques. Acute Normovolemic Hemodilution (ANH) collects patients own blood prior to the start of surgical procedure; Cell saver is the collection of blood lost during surgery with subsequent auto-transfusion of the patients own cells; Veno-venous bypass will be used for patients with anticipated large loss of blood during surgery (\>1L). The patients in the interventional group will be blinded to which blood sparing techniques utilized.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Overall Survival Up to 3 years postoperatively Assessment of survival after surgery
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 DeathQuality 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.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 DeathKidney Cancer Recurrence Up to 3 years postoperatively Assessment of recurrence of kidney cancer by radiographic imaging (CT or MRI)
Trial Locations
- Locations (3)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
H. Lee Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
Winship Cancer Institute at Emory University
🇺🇸Atlanta, Georgia, United States