Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer

N/AActive Not RecruitingNCT04922307

Vanderbilt University Medical Center240 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

240

Conditions

Kidney Cancer

Interventions

Blood Sparing ProtocolPROCEDURE

Acute Normovolemic Hemodilution, Cell Saver, and/or Veno-venous Bypass

Standard Blood ReplacementPROCEDURE

Allogenic blood transfusion as determined intra-operatively

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Winship Cancer Institute at Emory University

Atlanta, Georgia, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Number of units of allogenic blood transfusions

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

Time frame: Baseline to 30 days postoperatively

Secondary Outcomes

Number of Complications

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

Time frame: Baseline to 30 days and 90 days postoperatively

Grade of Complications

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

Time frame: Baseline to 30 days and 90 days postoperatively

Kidney Cancer Recurrence

Assessment of recurrence of kidney cancer by radiographic imaging (CT or MRI)

Time frame: Up to 3 years postoperatively

Data from ClinicalTrials.gov

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