Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer

NCT ID: NCT04922307

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-23
• Study Completion Date: 2027-06-15

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).

Conditions

Kidney Cancer

Keywords

nephrectomy; blood sparing; allogenic blood transfusion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Blood Sparing Protocol

Intervention Type: PROCEDURE

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

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.

Group Type: ACTIVE_COMPARATOR

Standard Blood Replacement

Intervention Type: PROCEDURE

Allogenic blood transfusion as determined intra-operatively

Interventions

Blood Sparing Protocol

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

Intervention Type: PROCEDURE

Standard Blood Replacement

Allogenic blood transfusion as determined intra-operatively

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Kelvin Moses

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kelvin Moses

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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

Countries

United States

Other Identifiers

IRB#202548

Identifier Type: -

Identifier Source: org_study_id