Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer

NCT04922307 | Active Not Recruiting

• 1 other identifier: IRB#202548
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

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.

Conditions

Kidney Cancer

Keywords

nephrectomy; blood sparing; allogenic blood transfusion

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline to 30 days postoperatively

Secondary Outcomes (5)

• Number of Complications

  Baseline to 30 days and 90 days postoperatively

• Grade of Complications

  Baseline to 30 days and 90 days postoperatively

• Kidney Cancer Recurrence

  Up to 3 years postoperatively

• Overall Survival

  Up to 3 years postoperatively

• Quality of life as measured by Functional Assessment of Cancer Therapy-Kidney Symptom Index (FSKI-19)

  Pre-operative, 1 and 3 months postoperatively

Study Arms (2)

Blood Sparing Protocol

EXPERIMENTAL

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.

Procedure: Blood Sparing Protocol

Standard Blood Replacement

ACTIVE COMPARATOR

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.

Procedure: Standard Blood Replacement

Interventions

Blood Sparing Protocol PROCEDURE

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

Blood Sparing Protocol

Standard Blood Replacement PROCEDURE

Allogenic blood transfusion as determined intra-operatively

Standard Blood Replacement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/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.

You may not qualify if:

• Male and female younger than 18 years old.
• Non-surgical candidate
• Unstable angina.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (3)

H. Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Winship Cancer Institute at Emory University

Atlanta, Georgia, 30322, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Kelvin Moses

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 10, 2021
• Study Start: July 23, 2021
• Primary Completion: February 12, 2025
• Study Completion (Estimated): June 15, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)