ARCA-1 Study: Perioperative Care in the Cancer Patient -1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 1
- 主要终点
- All causes of mortality
研究概览
简要总结
This study investigates the association of blood transfusions given around the time of surgery (perioperative) with complications after surgery (postoperative), cancer progression, and mortality after major oncologic non-cardiac surgery. The administration of blood products is an important clinical therapy to treat life-threatening blood (hematological) disorders (i.e. anemia, coagulation disorders or thrombocytopenia) in patients with cancer undergoing major non-cardiac surgery. On the other hand, the unnecessary exposure of those patients to blood products can be associated with the occurrence of unwanted severe complications and potentially increase the risk of death. An accurate understanding of the short and long-term outcomes, the patterns of blood transfusions, and the triggers of blood product administration may help researchers design and test the safety of perioperative blood transfusions in patients with cancer.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate if perioperative blood transfusions are associated with 1-year mortality.
SECONDARY OBJECTIVES:
I. To evaluate the association of blood transfusion with postoperative complications, 30 days mortality and cancer progression after major oncologic non-cardiac surgery.
II. To gain knowledge on prevalence and patterns of blood product administration worldwide, the incidence and management of perioperative anemia and the incidence and treatment of perioperative coagulopathies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient undergoing major cancer surgery with curative intent
- •Planned length of stay 24 hours after surgery or longer
- •American Society of Anesthesiologists physical status (ASA) 1-4
- •Scheduled, non-emergency surgery
排除标准
- •Emergency surgery
- •Palliative surgeries for metastatic disease (non-curative intent)
- •Patients undergoing surgery with minimum risk (< 1%) of blood transfusion according to each center practice (i.e. simple mastectomy, thyroidectomies or wide-local excisions)
- •Patients undergoing surgery under local anesthesia
- •Patients undergoing ambulatory surgery or planned hospital admission of less than 24 hours
结局指标
主要结局
All causes of mortality
时间窗: 1 year after major oncologic non-cardiac surgery
次要结局
- Cancer-specific mortality(1 year after major oncologic non-cardiac surgery)
- Progression free survival (PFS)(From the date of surgery to the date of progression or death whichever happened first, assessed at 1 year after major oncologic non-cardiac surgery)
- 30 days mortality(30 days after major oncologic non-cardiac surgery)
- Rate of perioperative blood products transfusion(During surgery and up to 2 weeks post surgery)