Salvaged Red Blood Cell Transfusion During Pancreatic Adenocarcinoma Operations

Обзор

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.

Вмешательства

• Устройство The Fresenius Kabi C.A.T.S®plus Continuous AutoTransfusion System
  A cell salvage device will be utilized to collect all spilled blood during the course of the operative resection and vascular reconstruction.

Первичные конечные точки

• Rate of sepsis within 72 hours of operations [Срок оценки: within 72 hours of operations]
• Rate of transfusion related complication within the first 72 hours [Срок оценки: Up to 7 days post-operative]
• Rate of all adverse events in the first post-operate week [Срок оценки: Up to 7 days post-operative]

Вторичные конечные точки (2)

• Units of aRBC required on post-operative day 0 [Срок оценки: Post-operative day 0 (up to 24 hours)]]
• Units of aRBC required on post-operative day 1-7 [Срок оценки: Post-operative days 1-7]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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%.
• Metastases
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• NYU Langone Health — New York

Идентификаторы

NCT: NCT07598357 · 25-01196

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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