Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer (RESTRICT)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Kidney Cancer
• Intervention / Treatment: Procedure: Blood Sparing Protocol; Procedure: Standard Blood Replacement

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).

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H. Lee Moffitt Cancer Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Winship Cancer Institute at Emory University
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Blood Sparing Protocol; Acute Normovolemic Hemodilution, Cell Saver, and/or Veno-venous Bypass
Active Comparator: 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.	Procedure: Standard Blood Replacement; Allogenic blood transfusion as determined intra-operatively

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Complications	Number of complications will be assessed by Clavien-Dindo Index Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II Pharmacological treatment with drugs other than such allowed for grade I. Grade III Requiring surgical, endoscopic or radiological intervention; IIIa Not under general anesthesia; IIIb Under general anesthesia Grade IV Life-threatening complication (including CNS complications)* requiring IC/ICU- management; IVa single organ dysfunction (including dialysis); IVb multiorgan dysfunction Grade V Death	Baseline to 30 days and 90 days postoperatively
Grade of Complications	Grade of complications will be assessed by Clavien-Dindo Index Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II Pharmacological treatment with drugs other than such allowed for grade I. Grade III Requiring surgical, endoscopic or radiological intervention; IIIa Not under general anesthesia; IIIb Under general anesthesia Grade IV Life-threatening complication (including CNS complications)* requiring IC/ICU- management; IVa single organ dysfunction (including dialysis); IVb multiorgan dysfunction Grade V Death	Baseline to 30 days and 90 days postoperatively
Kidney Cancer Recurrence	Assessment of recurrence of kidney cancer by radiographic imaging (CT or MRI)	Up to 3 years postoperatively
Overall Survival	Assessment of survival after surgery	Up to 3 years postoperatively
Quality of life as measured by Functional Assessment of Cancer Therapy-Kidney Symptom Index (FSKI-19)	Assessment of quality of life measures postoperatively, scores range from 0-76, with higher scores indicating worse symptoms Score range: 0-76 A score of "0" is a severely symptomatic patient and the highest possible score is an asymptomatic patient.	Pre-operative, 1 and 3 months postoperatively

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Kelvin Moses, Associate professor

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2021
• Primary Completion (Actual): February 12, 2025
• Study Completion (Estimated): June 15, 2027

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 10, 2021

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 10, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: nephrectomy; allogenic blood transfusion; blood sparing
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Kidney Neoplasms
• Other Study ID Numbers: IRB#202548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No