Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer

  • STATUS
    Recruiting
  • End date
    Jun 15, 2026
  • participants needed
    240
  • sponsor
    Vanderbilt University Medical Center
Updated on 7 August 2021
cancer
nephrectomy

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.

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).

Details
Condition urinary tract neoplasm, Malignant neoplasm of kidney, Nephropathy, Kidney Cancer, Renal Cancer, cancer, renal
Treatment Blood Sparing Protocol, Standard Blood Replacement
Clinical Study IdentifierNCT04922307
SponsorVanderbilt University Medical Center
Last Modified on7 August 2021

Eligibility

Yes No Not Sure

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
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/l
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
Clear my responses

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