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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years postoperatively
Awards & highlights
RESTRICT Trial 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.Check my eligibility
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.See study design
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.
RESTRICT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
RESTRICT Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of units of allogenic blood transfusions
Secondary outcome measures
Grade of Complications
Kidney Cancer Recurrence
Number of Complications
+2 moreRESTRICT 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.
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
671,952 Total Patients Enrolled
Kelvin MosesPrincipal Investigator - Associate Professor
Vanderbilt University Hospital
Baylor College Of Medicine (Medical School)
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