Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 15, 2024

Detailed Description

The Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer Trial (RESTRICT) is a randomized study to investigate blood sparing using autologous normovolemic hemodilution (ANH) or cell salvage at the time of nephrectomy for locally advanced kidney cancer after assessing inclusion criteria patients will be randomized to undergo standard blood management including the possibility of allogenic transfusion vs autologous blood transfusion. There are multiple ways patients can receive allogenic or autologous blood, including veno-venous bypass or cardiopulmonary bypass (typically reserved for patients with a thrombus above the level of the hepatic veins or entering the heart).

Interventions

  • Procedure: Blood Sparing Protocol
    • Acute Normovolemic Hemodilution, Cell Saver, and/or Veno-venous Bypass
  • Procedure: Standard Blood Replacement
    • Allogenic blood transfusion as determined intra-operatively

Arms, Groups and Cohorts

  • Experimental: Blood Sparing Protocol
    • 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.
  • Active Comparator: Standard Blood Replacement
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Number of units of allogenic blood transfusions
    • Time Frame: Baseline to 30 days postoperatively
    • The primary goal of the study is to evaluate the impact of the blood sparing techniques on the reduction of allogenic blood transfusion in locally advanced kidney cancer. The total number of allogenic blood units used at the end of each case will be assessed

Secondary Measures

  • Number of Complications
    • Time Frame: Baseline to 30 days and 90 days postoperatively
    • Number of complications will be assessed by Clavien-Dindo Index Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II Pharmacological treatment with drugs other than such allowed for grade I. Grade III Requiring surgical, endoscopic or radiological intervention IIIa Not under general anesthesia IIIb Under general anesthesia Grade IV Life-threatening complication (including CNS complications)* requiring IC/ICU- management IVa single organ dysfunction (including dialysis) IVb multiorgan dysfunction Grade V Death
  • Grade of Complications
    • Time Frame: Baseline to 30 days and 90 days postoperatively
    • Grade of complications will be assessed by Clavien-Dindo Index Grade I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Grade II Pharmacological treatment with drugs other than such allowed for grade I. Grade III Requiring surgical, endoscopic or radiological intervention IIIa Not under general anesthesia IIIb Under general anesthesia Grade IV Life-threatening complication (including CNS complications)* requiring IC/ICU- management IVa single organ dysfunction (including dialysis) IVb multiorgan dysfunction Grade V Death
  • Kidney Cancer Recurrence
    • Time Frame: Up to 3 years postoperatively
    • Assessment of recurrence of kidney cancer by radiographic imaging (CT or MRI)
  • Overall Survival
    • Time Frame: Up to 3 years postoperatively
    • Assessment of survival after surgery
  • Quality of life as measured by FSKI-19
    • Time Frame: Pre-operative, 1 and 3 months postoperatively
    • Assessment of quality of life measures postoperatively

Participating in This Clinical Trial

Inclusion Criteria

  • Renal masses ≥ cT2 (by any conventional imaging). – N1 or M1 disease is allowed if they are deemed surgical candidates (including cytoreductive nephrectomy). – Male and female patients. – 18 and older. – Ejection fraction (EF) ≥ 45% by echocardiogram (ECHO). – Adequate organ function as defined by: – Hemoglobin ≥ 9 g/dL. Pre-operative allogenic blood transfusion is allowed. – Platelets ≥ 100.000/μl. – Albumin ≥ 2.5 g/dL. – Aspartate Aminotransferase (AST) and alanine transaminase (ALT) ≤ 75U/L or total bilirubin ≤ 2.0 mg/dL. – WBC within institutional normal limits. – PT within institutional normal limits. – INR < 1.5 and PTT normal. – Consent and compliance with all aspects of the study protocol. Exclusion Criteria:

  • Male and female younger than 18 years old. – Non-surgical candidate – Unstable angina.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kelvin Moses, Associate Professor – Vanderbilt University Medical Center
  • Overall Official(s)
    • Kelvin Moses, Principal Investigator, Associate Professor
  • Overall Contact(s)
    • Kelvin Moses, MD, PhD, 615-343-1317, kelvin.a.moses@vumc.org

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.