Reduction of Donor Blood Transfusion in Patients During Surgery for in Patients with Locally Advanced Kidney Cancer
Kidney Cancer
Unknown Primary
18 Years and older, Male and Female
VICCURO2114 (primary)
NCI-2021-10595
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.
Eligibility
- 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
- For patients with known, or suspected heart failure or severe cardiac disease, an echocardiogram may be performed. For those patients, an ejection fraction (EF) >= 45% is required for inclusion
- Hemoglobin >= 9 g/dL. Pre-operative allogenic blood transfusion is allowed
- Platelets >= 100,000/uL
- Albumin >= 2.5 g/dL
- Aspartate aminotransferase (AST) and alanine transaminase (ALT) =< 75 U/L or total bilirubin =< 2.0 mg/dL
- White blood cells (WBC) within institutional normal limits
- Prothrombin time (PT) within institutional normal limits
- International normalized ratio < 1.5
- Consent and compliance with all aspects of the study protocol
**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...
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