← Back to Search

Blood Sparing Protocol for Kidney Cancer (RESTRICT Trial)

N/A

Waitlist Available

Led By Kelvin Moses

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hemoglobin ≥ 9 g/dL. Pre-operative allogenic blood transfusion is allowed

Renal masses ≥ cT2 (by any conventional imaging)

Must not have

Male and female younger than 18 years old

Non-surgical candidate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years postoperatively

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to reduce the number of blood transfusions needed in kidney cancer surgery and improve patient outcomes.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While specific side effects aren't listed, potential risks could include complications related to not receiving enough donor blood if needed during surgery, such as increased fatigue or lowered immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My hemoglobin level is at least 9 g/dL.

Select...

My kidney tumor is larger than a specific size.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Select...

I am not eligible for surgery to treat my condition.

Select...

I have unstable chest pain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of units of allogenic blood transfusions

Secondary study objectives

Grade of Complications

Kidney Cancer Recurrence

Number of Complications

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 6Eligibility criteria met