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Salvaged Red Blood Cell Transfusion During Pancreatic Adenocarcinoma Operations

2026年5月14日 更新者:NYU Langone Health

The purpose of this study is to prospectively study the safety of salvage red blood cell (sRBC) transfusion during pancreatic surgery.

Primary Objective:

  1. 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.
  2. To summarize rates and timing of transfusion related AEs for patients who receive sRBC or aRBC transfusions within 72 hours of peri-operative transfusion.
  3. To summarize rates and timing of AEs in the first 7 post-operative days.

Secondary Objectives:

  1. To summarize the number of units of aRBC transfused post operative day (POD) #0 after sRBC transfusion in the operating room.
  2. 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.

研究概览

研究类型

介入性

注册 (估计的)

40

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

    • New York
      • New York、New York、美国、10016
        • NYU Langone Health

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. 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.
  2. Patient is 18 years of age or older
  3. Patient has a diagnosis of cytologically or pathologically confirmed pancreatic adenocarcinoma
  4. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  5. Patient has an American Society of Anesthesiologists (ASA) classification of physical health status of 1-4
  6. Life expectancy of greater than six months
  7. Hemoglobin > 8.9 g/dl
  8. Platelet count greater than 200,000/mm3
  9. International Normalization Ratio ≤1.8
  10. Total serum bilirubin ≤ 2 mg/dL
  11. Serum creatinine ≤ 1.5 mg/dl
  12. 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.

Exclusion Criteria:

  1. Concomitant medical problems that would place the patient at unacceptable risk for a major surgical procedure.
  2. History of congestive heart failure and/or an LVEF <40%.
  3. Metastases
  4. Active systemic infections, hematological diseases, coagulation disorders or other major medical illnesses of the cardiovascular, hepatic, renal, respiratory or immune system.
  5. Patients with transabdominal drains, or peripancreatic abscess or fluid collections on cross-sectional imaging.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Autologous group - sRBC
Patients with enough salvaged blood to generate a unit for transfusion will be transfused their own (autologous) blood, as long as they were not transfused allogeneic red blood cell (aRBC) during the same operation
A cell salvage device will be utilized to collect all spilled blood during the course of the operative resection and vascular reconstruction.
实验性的:Allogeneic group - aRBC
Patients requiring transfusion at the discretion of the surgeon and the anesthesiologist without enough salvaged blood to generate a unit for transfusion will be transfused aRBC.
A cell salvage device will be utilized to collect all spilled blood during the course of the operative resection and vascular reconstruction.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Rate of sepsis within 72 hours of operations
大体时间:within 72 hours of operations
within 72 hours of operations
Rate of transfusion related complication within the first 72 hours
大体时间:Up to 7 days post-operative
Up to 7 days post-operative
Rate of all adverse events in the first post-operate week
大体时间:Up to 7 days post-operative
Up to 7 days post-operative

次要结果测量

结果测量
大体时间
Units of aRBC required on post-operative day 0
大体时间:Post-operative day 0 (up to 24 hours)]
Post-operative day 0 (up to 24 hours)]
Units of aRBC required on post-operative day 1-7
大体时间:Post-operative days 1-7
Post-operative days 1-7

其他结果措施

结果测量
大体时间
Months until date of first biopsy or imaging evidence of progression, agreed upon by at multidisciplinary conference or months until death, if death occurs without disease progression
大体时间:Until study completion (up to 5 years)
Until study completion (up to 5 years)
Months until date of death from any cause
大体时间:Until study completion (up to 5 years)]
Until study completion (up to 5 years)]

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Michael D. Kluger, MD, MPH、NYU Langone Health

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月1日

初级完成 (估计的)

2028年5月1日

研究完成 (估计的)

2031年6月1日

研究注册日期

首次提交

2026年5月14日

首先提交符合 QC 标准的

2026年5月14日

首次发布 (实际的)

2026年5月20日

研究记录更新

最后更新发布 (实际的)

2026年5月20日

上次提交的符合 QC 标准的更新

2026年5月14日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 25-01196

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

The sample size in this exploratory study is small such that data sharing may risk breaching confidentiality.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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