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Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer (RESTRICT)

Primary Purpose

Kidney Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Sparing Protocol
Standard Blood Replacement
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring nephrectomy, blood sparing, allogenic blood transfusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • H. Lee Moffitt Cancer Center
  • Winship Cancer Institute at Emory University
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blood Sparing Protocol

Standard Blood Replacement

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of units of allogenic blood transfusions
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 Outcome Measures

Number of Complications
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
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
Assessment of recurrence of kidney cancer by radiographic imaging (CT or MRI)
Overall Survival
Assessment of survival after surgery
Quality of life as measured by Functional Assessment of Cancer Therapy-Kidney Symptom Index (FSKI-19)
Assessment of quality of life measures postoperatively, scores range from 0-76, with higher scores indicating worse symptoms Score range: 0-76 A score of "0" is a severely symptomatic patient and the highest possible score is an asymptomatic patient.

Full Information

First Posted
June 4, 2021
Last Updated
October 1, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04922307
Brief Title
Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer
Acronym
RESTRICT
Official Title
Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 23, 2021 (Actual)
Primary Completion Date
June 15, 2025 (Anticipated)
Study Completion Date
June 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
nephrectomy, blood sparing, allogenic blood transfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Blood Sparing Protocol
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Blood Replacement
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Blood Sparing Protocol
Intervention Description
Acute Normovolemic Hemodilution, Cell Saver, and/or Veno-venous Bypass
Intervention Type
Procedure
Intervention Name(s)
Standard Blood Replacement
Intervention Description
Allogenic blood transfusion as determined intra-operatively
Primary Outcome Measure Information:
Title
Number of units of allogenic blood transfusions
Description
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
Time Frame
Baseline to 30 days postoperatively
Secondary Outcome Measure Information:
Title
Number of Complications
Description
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
Time Frame
Baseline to 30 days and 90 days postoperatively
Title
Grade of Complications
Description
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
Time Frame
Baseline to 30 days and 90 days postoperatively
Title
Kidney Cancer Recurrence
Description
Assessment of recurrence of kidney cancer by radiographic imaging (CT or MRI)
Time Frame
Up to 3 years postoperatively
Title
Overall Survival
Description
Assessment of survival after surgery
Time Frame
Up to 3 years postoperatively
Title
Quality of life as measured by Functional Assessment of Cancer Therapy-Kidney Symptom Index (FSKI-19)
Description
Assessment of quality of life measures postoperatively, scores range from 0-76, with higher scores indicating worse symptoms Score range: 0-76 A score of "0" is a severely symptomatic patient and the highest possible score is an asymptomatic patient.
Time Frame
Pre-operative, 1 and 3 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelvin Moses
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Winship Cancer Institute at Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer

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