Blood Sparing Protocol for Kidney Cancer

(RESTRICT Trial)

Not currently recruiting at 2 trial locations

Overseen By Pam Steele

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Under 18, Non-surgical, Unstable angina

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to reduce the need for donated blood transfusions in individuals undergoing surgery for advanced kidney cancer. It tests a new blood-sparing technique, known as the Blood Sparing Protocol, against the usual practice to determine if it can lead to fewer complications and better survival rates post-surgery. Suitable candidates for this trial have kidney tumors of significant size (classified as cT2 or larger) and are eligible for surgery. Participants will be randomly assigned to receive either the new blood-sparing protocol or standard blood transfusions during their surgery. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance surgical outcomes for future patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this blood sparing protocol is safe for kidney cancer patients?

In a previous study, a technique called Acute Normovolemic Hemodilution (ANH), part of the Blood Sparing Protocol, reduced the need for blood transfusions by 27%. This technique involves collecting a patient's own blood before surgery and returning it afterward if needed. Research has shown that this approach can be safe, especially for surgeries with expected blood loss.

Another technique, cell salvage, collects and returns the patient's own blood lost during surgery. This method aims to reduce the use of donor blood. Although specific data on side effects is limited, these techniques are generally well-tolerated because they use the patient's own blood, reducing the risk of reactions associated with donor blood transfusions.

Overall, these methods aim to safely reduce the need for transfusions. However, because this trial is in a phase labeled "Not Applicable," data on side effects specific to kidney cancer surgery may be limited. As with any medical procedure, individual experiences can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Blood Sparing Protocol for kidney cancer because it offers a potentially safer alternative to traditional blood transfusions during surgery. This protocol uses techniques like Acute Normovolemic Hemodilution and cell saver technology to collect and reuse the patient's own blood, minimizing reliance on donor blood. These innovative methods aim to reduce the risks associated with blood transfusions, such as immune reactions and infections, offering a more personalized and potentially safer approach to managing blood loss during kidney cancer surgery.

What evidence suggests that the Blood Sparing Protocol is effective for reducing allogenic blood transfusion in kidney cancer?

Research has shown that the Blood Sparing Protocol, a treatment in this trial, can significantly reduce the need for blood transfusions during kidney cancer surgeries. This protocol involves techniques such as collecting a patient's blood before surgery and reinfusing it afterward, as well as collecting and reinfusing blood lost during surgery. These methods effectively reduce the use of donor blood, which can lower the risk of complications and aid recovery. Therefore, the Blood Sparing Protocol may benefit those undergoing surgery for advanced kidney cancer. In contrast, the Standard Blood Replacement treatment arm involves surgery without these blood-sparing techniques, using cross-matched allogenic blood products as needed. ^{2 6 7 8 9}

Who Is on the Research Team?

Kelvin Moses

Principal Investigator

Associate Professor

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

I am under 18 years old.

I am not eligible for surgery to treat my condition.

I have unstable chest pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo radical nephrectomy with or without blood-sparing techniques

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety, complications, and effectiveness after surgery

3 months

3 visits (in-person)

Long-term follow-up

Assessment of overall survival and kidney cancer recurrence

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Blood Sparing Protocol
• Standard Blood Replacement

Trial Overview 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.

How Is the Trial Designed?

Group I: Blood Sparing Protocol Experimental Treatment 1 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 Replacement Active Control 1 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.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. withpower.com withpower.com/trial/phase-carcinoma-renal-cell-6-2021-856b8

Blood Sparing Protocol for Kidney Cancer (RESTRICT Trial) The Blood Sparing Protocol for kidney cancer is unique because it focuses on minimizing the need for blood transfusions during surgery, using techniques like ...

2. georgiacancerinfo.org georgiacancerinfo.org/trialDetailPrint.aspx?trialID=5152

Clinical Trial Details | GCI Techniques that can reduce the need for allogenic blood transfusion include acute normovolemic hemodilution and cell salvage, which use the patient's own ...

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-10595

Reduction of Donor Blood Transfusion in Patients During ... Techniques that can reduce the need for allogenic blood transfusion include acute normovolemic hemodilution and cell salvage, which use the patient's own ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/12357142/

Effectiveness of acute normovolemic hemodilution to ... The primary efficacy endpoint was the avoidance of allogeneic blood transfusion in the intraoperative period and first 72 h after surgery.

5. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04922307?keyword=%22Nephrectomy%22

Reduction of Allogenic Blood Transfusion in Locally ... The Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer Trial (RESTRICT) is a randomized study to investigate blood sparing using ...

6. ouhsc.edu ouhsc.edu/news/details/study-shows-blood-conservation-technique-reduces-odds-of-transfusion-during-heart-surgery-in-united-states

Study Shows Blood Conservation Technique Reduces ... Yet the study found that ANH lowered the likelihood of a transfusion by 27%, a decrease in blood use that could cut costs substantially while ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11251377/

Strategies to prevent blood loss and reduce transfusion in ... Acute normovolemic hemodilution (ANH) is a blood conservation technique consisting in removal of whole blood from a patient immediately ...

8. researchgate.net researchgate.net/publication/392211100_Acute_Normovolemic_Hemodilution_ANH

Acute Normovolemic Hemodilution (ANH) ANH is most effective when the surgery is associated with significant blood loss and the patient can tolerate a relatively large amount of blood ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10486190/

Cell salvage for minimising perioperative allogeneic blood ... Cell salvage (CS) describes the recovery of blood from the surgical field, either during or after surgery, for reinfusion back to the patient.