NCT07598357尚未招募不适用
Salvaged Red Blood Cell Transfusion During Pancreatic Adenocarcinoma Operations
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The purpose of this study is to prospectively study the safety of salvage red blood cell (sRBC) transfusion during pancreatic surgery.
Primary Objective:
- To summarize rates and timing of septic adverse events (AE) for patients who receive sRBC or aRBC transfusions within 72 hours of peri-operative transfusion.
- To summarize rates and timing of transfusion related AEs for patients who receive sRBC or aRBC transfusions within 72 hours of peri-operative transfusion.
- To summarize rates and timing of AEs in the first 7 post-operative days.
Secondary Objectives:
- To summarize the number of units of aRBC transfused post operative day (POD) #0 after sRBC transfusion in the operating room.
- To summarize the number of units of aRBC transfused POD#1-7 after sRBC transfusion the operating room, in the absence of overt post-operative hemorrhage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Provision of signed and dated informed consent form. Able to understand their disease and the exploratory nature of sRBC transfusion during surgery for this histology.
- •Patient is 18 years of age or older
- •Patient has a diagnosis of cytologically or pathologically confirmed pancreatic adenocarcinoma
- •Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- •Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1-4
- •Life expectancy of greater than six months
- •Hemoglobin > 8.9 g/dl
- •Platelet count greater than 200,000/mm3
- •International Normalization Ratio ≤1.8
- •Total serum bilirubin ≤ 2 mg/dL
- •Serum creatinine ≤ 1.5 mg/dl
- •Recovered from any hematologic toxicity less than grade 3 from all prior chemotherapy or radiotherapy, and be at least 14 days past the date of their last treatment.
排除标准
- •Concomitant medical problems that would place the patient at unacceptable risk for a major surgical procedure.
- •History of congestive heart failure and/or an LVEF <40%.
- •Active systemic infections, hematological diseases, coagulation disorders or other major medical illnesses of the cardiovascular, hepatic, renal, respiratory or immune system.
- •Patients with transabdominal drains, or peripancreatic abscess or fluid collections on cross-sectional imaging.
研究者
研究点 (1)
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