Clinical trial · Interventional
Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer
NCT04922307CI-TRIAL-00097135RESTRICTactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Sparing Protocol | Procedure | — | UNRESOLVED |
| Standard Blood Replacement | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Blood Sparing Protocol
- 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.
- interventionNames
- Procedure: Blood Sparing Protocol
- type
- ACTIVE_COMPARATOR
- label
- Standard Blood Replacement
- 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.
- interventionNames
- Procedure: Standard Blood Replacement
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.