Blood Sparing Protocol for Kidney Cancer

(RESTRICT Trial)

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

240 Participants Needed

Trial Summary

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 data supports the effectiveness of the Blood Sparing Protocol treatment for kidney cancer?

The research suggests that avoiding blood transfusions during kidney cancer surgery may improve outcomes, as intraoperative blood transfusions are linked to higher risks of cancer recurrence and mortality. This implies that a blood-sparing approach could potentially be beneficial in reducing these risks. ^{1 2 3 4 5}

Is the Blood Sparing Protocol generally safe for humans?

The studies reviewed focus on blood loss and transfusion during kidney cancer surgeries, but they do not directly address the safety of the Blood Sparing Protocol itself. However, one study found that blood transfusions did not negatively impact long-term survival after kidney surgery, suggesting that managing blood loss during such procedures is generally safe. ^{1 6 7 8 9}

How does the Blood Sparing Protocol treatment for kidney cancer differ from other treatments?

The Blood Sparing Protocol for kidney cancer is unique because it focuses on minimizing the need for blood transfusions during surgery, using techniques like preoperative autologous blood donation and intraoperative cell salvage with leukocyte depletion filters. This approach aims to reduce complications associated with blood transfusions, which can impact recovery and survival rates. ^{1 3 10 11 12}

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.

Exclusion Criteria

I am under 18 years old.

I am not eligible for surgery to treat my condition.

I have unstable chest pain.

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Blood loss and the need for transfusion in patients who undergo partial or radical nephrectomy for renal cell carcinoma. [2017]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

Impact of perioperative blood transfusion on oncologic outcomes in patients with nonmetastatic renal cell carcinoma treated with curative nephrectomy: A retrospective analysis of a large, single-institutional cohort. [2021]

3. France pubmed.ncbi.nlm.nih.gov

Impact of blood transfusion on survival after nephrectomy for localized or locally advanced renal cancer. [2022]

4. Greece pubmed.ncbi.nlm.nih.gov

Prognostic Significance of Preoperative Anemia in Patients Undergoing Surgery for Renal Cell Carcinoma: A Meta-analysis. [2017]

5. England pubmed.ncbi.nlm.nih.gov

Intraoperative but not postoperative blood transfusion adversely affect cancer recurrence and survival following nephrectomy for renal cell carcinoma. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Risk factors and clinical management of haemorrhage after open nephron-sparing surgery. [2010]

7. England pubmed.ncbi.nlm.nih.gov

The impact of comorbidities, sex and age on the occurrence of acute kidney injury among patients undergoing nephron-sparing surgery. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Blood transfusion and survival following nephrectomy for carcinoma of kidney. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and safety of TachoSil as haemostatic treatment versus standard suturing in kidney tumour resection: a randomised prospective study. [2022]

10. Japan pubmed.ncbi.nlm.nih.gov

[Clinical experience of autologous blood transfusion in patients undergoing nephrectomy with renal cell carcinoma]. [2006]

11. China pubmed.ncbi.nlm.nih.gov

[Application of intraoperative cell salvage combined with leukocyte depletion filter on radical nephrectomy for renal carcinoma with inferior vena cava tumor thrombus: 2 case reports]. [2019]

12. England pubmed.ncbi.nlm.nih.gov

Preoperative hypoalbuminemia and anemia as predictors of transfusion in radical nephrectomy for renal cell carcinoma: a retrospective study. [2018]