Reduction of Donor Blood Transfusion in Patients During Surgery for in Patients with Locally Advanced Kidney Cancer

Active:	Yes
Cancer Type:	Kidney Cancer Unknown Primary	NCT ID:	NCT04922307
Trial Phases:		Protocol IDs:	VICCURO2114 (primary) NCI-2021-10595
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Vanderbilt University/Ingram Cancer Center
NCI Full Details:	http://clinicaltrials.gov/show/NCT04922307

Summary

This clinical trial evaluates which methods of blood transfusion are best for patients undergoing kidney surgery. Allogenic (donor) blood transfusion has been shown to cause more side effects (with the lungs, immune system, and circulation, for example) as well as worse cancer outcomes. These concerns have encouraged methods to decrease allogenic blood transfusion. Blood transfusion is defined as a medical treatment that replaces blood that is lost during surgery and is causing changes in blood pressure or heart rate due to that loss. There are two sources of blood for transfusion, allogenic and autologous. Allogenic blood is blood that is provided from healthy blood donors. Autologous blood is provided from the patient for their own use. Techniques that can reduce the need for allogenic blood transfusion include acute normovolemic hemodilution and cell salvage, which use the patient's own blood (autologous) in transfusion. This study aims to reduce the number of units of allogenic (donated) blood that is
transfused.

Objectives

PRIMARY OBJECTIVE:
I. To reduce the number of units of allogenic blood transfusion in locally advanced kidney cancer.

SECONDARY OBJECTIVES:
I. Reduction in perioperative complications.
II. Assessment of recurrence free-survival.
III. Improving overall survival.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: During standard of care nephrectomy, patients undergo autologous normovolemic hemodilution or cell salvage autologous transfusion.

ARM II: Patients undergo allogenic blood transfusion as needed, during or after standard of care nephrectomy.

After completion of study treatment, patients are followed up for up to 3 months.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.