Clinical trial NCT04922307: Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer
Official title: Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Kidney Cancer
Keywords: nephrectomy
blood sparing
allogenic blood transfusion
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2021-06-10
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Number of units of allogenic blood transfusions
timeFrame: Baseline to 30 days postoperatively
Secondary outcomes:
measure: Number of Complications
timeFrame: Baseline to 30 days and 90 days postoperatively
measure: Grade of Complications
timeFrame: Baseline to 30 days and 90 days postoperatively
measure: Kidney Cancer Recurrence
timeFrame: Up to 3 years postoperatively
measure: Overall Survival
timeFrame: Up to 3 years postoperatively
measure: Quality of life as measured by Functional Assessment of Cancer Therapy-Kidney Symptom Index (FSKI-19)
timeFrame: Pre-operative, 1 and 3 months postoperatively
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute at Emory University
state: Georgia
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Associate Professor
name: Kelvin Moses
role: PRINCIPAL_INVESTIGATOR
References: