Reduction of Allogenic Blood Transfusion in Locally Advanced Kidney Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 3
- 主要终点
- Number of units of allogenic blood transfusions
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Male and female younger than 18 years old.
- •Non-surgical candidate
- •Unstable angina.
研究组 & 干预措施
Blood Sparing Protocol
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.
干预措施: Blood Sparing Protocol (Procedure)
Standard Blood Replacement
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.
干预措施: Standard Blood Replacement (Procedure)
结局指标
主要结局
Number of units of allogenic blood transfusions
时间窗: 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
次要结局
- Quality of life as measured by Functional Assessment of Cancer Therapy-Kidney Symptom Index (FSKI-19)(Pre-operative, 1 and 3 months postoperatively)
- Number of Complications(Baseline to 30 days and 90 days postoperatively)
- Kidney Cancer Recurrence(Up to 3 years postoperatively)
- Overall Survival(Up to 3 years postoperatively)
- Grade of Complications(Baseline to 30 days and 90 days postoperatively)
研究者
Kelvin Moses
Associate Professor
Vanderbilt University Medical Center