Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer

Kidney Cancer Clinical Trial

— RESTRICT  

Official title:

Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04922307
• Other study ID #: 202548
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 23, 2021
• Est. completion date: June 15, 2027

Study information

• Verified date: October 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 240
• Est. completion date: June 15, 2027
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Winship Cancer Institute at Emory University	Atlanta	Georgia
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline to 30 days postoperatively
Secondary	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	Baseline to 30 days and 90 days postoperatively
Secondary	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	Baseline to 30 days and 90 days postoperatively
Secondary	Kidney Cancer Recurrence	Assessment of recurrence of kidney cancer by radiographic imaging (CT or MRI)	Up to 3 years postoperatively
Secondary	Overall Survival	Assessment of survival after surgery	Up to 3 years postoperatively
Secondary	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.	Pre-operative, 1 and 3 months postoperatively