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

Vanderbilt University Medical Center

Status: Active, not recruiting

Conditions: Kidney Cancer

Treatments: Procedure: Blood Sparing Protocol; Procedure: Standard Blood Replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT04922307

IRB#202548

Details and patient eligibility

About

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.

Full 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).

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Blood Sparing Protocol

Experimental group

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.

Treatment:

Procedure: Blood Sparing Protocol

Standard Blood Replacement

Active Comparator group

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.

Treatment:

Procedure: Standard Blood Replacement