Kidney CancerRESTRICTNCT04922307
Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer
A study testing Blood Sparing Protocol and Standard Blood Replacement in people with Kidney Cancer, run by Vanderbilt University Medical Center at 3 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Blood Sparing Protocol and Standard Blood Replacement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 3 sitesUnited States
- Study dates
- 23 Jul 2021to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 14Show fewer
- 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.
Who cannot join
- Male and female younger than 18 years old.
- Non-surgical candidate
- Unstable angina.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Winship Cancer Institute at Emory University
Atlanta, Georgia, 30322
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
H. Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
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.
Read the 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).
- Conditions
- Kidney Cancer
- Being tested
- Blood Sparing Protocol, Standard Blood Replacement
- Keywords
- nephrectomy, blood sparing, allogenic blood transfusion
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sparing ProtocolProcedure or surgery
Acute Normovolemic Hemodilution, Cell Saver, and/or Veno-venous Bypass
Standard Blood ReplacementProcedure or surgery
Allogenic blood transfusion as determined intra-operatively
| Study group | Role | What they receive |
|---|---|---|
| Blood Sparing Protocol | Experimental | 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. Receives: Procedure: Blood Sparing Protocol |
| Standard Blood Replacement | Active comparator | 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. Receives: Procedure: Standard Blood Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 30 days postoperatively
Secondary outcomes (5)
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
Measured: Baseline to 30 days and 90 days postoperatively
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
Measured: Baseline to 30 days and 90 days postoperatively
Kidney Cancer Recurrence
Assessment of recurrence of kidney cancer by radiographic imaging (CT or MRI)
Measured: Up to 3 years postoperatively
Overall Survival
Assessment of survival after surgery
Measured: Up to 3 years postoperatively
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.
Measured: Pre-operative, 1 and 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start23 Jul 2021
- Primary completion12 Feb 2025
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelvin Moses, Vanderbilt University Medical Center
- Investigators
- Kelvin Moses, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922307
- Sponsor's protocol ID
- IRB#202548
- Acronym
- RESTRICT
- Status last verified
- Nov 2025
- First submitted
- 4 Jun 2021
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer
- ClinicalTrials.gov ID
- NCT04922307
- Acronym / sponsor ID
- RESTRICT / IRB#202548
- Conditions
- Kidney Cancer
- Keywords
- nephrectomy, blood sparing, allogenic blood transfusion
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 23 Jul 2021 (actual)
- Primary completion
- 12 Feb 2025 (actual)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood Sparing Protocol | Experimental | Procedure: Blood Sparing ProtocolThe 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. |
| Standard Blood Replacement | Active comparator | Procedure: Standard Blood ReplacementThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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).
Key exclusion criteria (3 listed)
- Male and female younger than 18 years old.
- Non-surgical candidate
- Unstable angina.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sparing ProtocolAcute Normovolemic Hemodilution, Cell Saver, and/or Veno-venous Bypass | Procedure or surgery | Blood Sparing Protocol |
| Standard Blood ReplacementAllogenic blood transfusion as determined intra-operatively | Procedure or surgery | Standard Blood Replacement |
Primary outcome
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
5 secondary outcomes
Number of Complications
Time frame: Baseline to 30 days and 90 days postoperatively
Grade of Complications
Time frame: Baseline to 30 days and 90 days postoperatively
Kidney Cancer Recurrence
Time frame: Up to 3 years postoperatively
Overall Survival
Time frame: Up to 3 years postoperatively
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelvin Moses principal investigator
Associate Professor
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Sparing Protocol and Standard Blood Replacement in people with Kidney Cancer, run by Vanderbilt University Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of units of allogenic blood transfusions (time frame: Baseline to 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.