Blood Sparing Protocol for Kidney Cancer
(RESTRICT Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byKelvin Moses

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Vanderbilt University Medical Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Kelvin Moses

Principal Investigator

Associate Professor

Eligibility Criteria

This trial is for adults with advanced kidney cancer (≥ cT2), who may also have some spread to lymph nodes or distant sites but are still considered candidates for surgery. They must have a heart ejection fraction of at least 45%, adequate blood counts, liver function within certain limits, and agree to follow the study rules.

Inclusion Criteria

My cancer has spread to nearby lymph nodes or other parts of my body, but I am considered a candidate for surgery.

Your platelet count is at least 100,000 per microliter.

Your white blood cell count is within the normal range for the hospital or clinic where you are being treated.

See 11 more

Exclusion Criteria

I am under 18 years old.

I am not eligible for surgery to treat my condition.

I have unstable chest pain.

Treatment Details

Interventions

Blood Sparing Protocol (Procedure)
Standard Blood Replacement (Procedure)

Trial OverviewThe RESTRICT trial aims to reduce the need for blood transfusions from donors in patients undergoing surgery for advanced kidney cancer. It compares a new 'Blood Sparing Protocol' against the usual method of replacing blood during surgery.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Blood Sparing ProtocolExperimental Treatment1 Intervention

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.

Group II: Standard Blood ReplacementActive Control1 Intervention

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.