NCT04922307

Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
PROCEDURE	Blood Sparing Protocol	Acute Normovolemic Hemodilution, Cell Saver, and/or Veno-venous Bypass
PROCEDURE	Standard Blood Replacement	Allogenic blood transfusion as determined intra-operatively

Timeline

• Start date: 2021-07-23
• Primary completion: 2025-02-12
• Completion: 2027-06-15
• First posted: 2021-06-10
• Last updated: 2025-11-12

Locations

3 sites across 1 country: United States