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NCT Number: NCT04922307

Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Kidney Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center, Tampa, Florida, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Sparing Protocol

Procedure

Acute Normovolemic Hemodilution, Cell Saver, and/or Veno-venous Bypass

Standard Blood Replacement

Procedure

Allogenic blood transfusion as determined intra-operatively

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. Kidney Cancer Recurrence

    Time frame: Up to 3 years postoperatively

    Assessment of recurrence of kidney cancer by radiographic imaging (CT or MRI)

  4. Overall Survival

    Time frame: Up to 3 years postoperatively

    Assessment of survival after surgery

  5. Quality of life as measured by Functional Assessment of Cancer Therapy-Kidney Symptom Index (FSKI-19)

    Time frame: Pre-operative, 1 and 3 months postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Acronym: RESTRICT

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Jun 10, 2021
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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