Kidney Cancer Clinical Trial
Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer
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.
Full 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).
Eligibility Criteria
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.
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There are 3 Locations for this study
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Nashville Tennessee, 37232, United States
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