Open Label Randomized Trial of Blood Transfusions in Cancer Patients Following a Pancreatectomy: A Feasibility Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Rate of Protocol adherence
研究概览
简要总结
This clinical trial tests the the feasibility of testing a red blood cell transfusion threshold for improved quality of life for patients undergoing a pancreatectomy for pancreatic cancer. Pancreatectomy can be associated with significant blood loss. Blood loss can result in clinically important anemia causing fatigue. Pancreatic cancer itself can be associated with malnutrition and fatigue. Having a red blood cell transfusion threshold that results in a more liberal use of transfusions may improve quality of life for patients undergoing a pancreatectomy for pancreatic cancer.
详细描述
PRIMARY OBJECTIVE:
I. The primary objective for this pilot study is protocol adherence for the transfusion study we propose for pancreatectomy patients.
SECONDARY OBJECTIVES:
I. Determine the feasibility of collecting and processing of all data that will be collected in the full study.
II. Specific emphasis will be given to findings from Patient Reported Outcomes Measurement Information System (PROMIS)-29 to determine its sensitivity to changes in health related quality of life (HRQOL) that occur in the perioperative period after pancreatectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Male or female >= 18 years of age at Visit 1
- •Documentation of a pancreatic cancer diagnosis as evidenced by one or more clinical features meeting the following criteria:
- •CT evidence of a mass in the pancreas consistent with cancer
- •Tissue diagnosis of cancer either before surgery or from the resected specimen
- •Preoperative evaluation suggestive that pancreatic resection is feasible
- •Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
排除标准
- •Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
- •Patients who are unable to receive or who refuse blood products
- •Patients involved in an autologous pre-donation program
- •Patients found to have metastatic disease upon entry into abdomen-having been randomized, these patients will be removed from the study and replaced with another patient
- •Patients found to not have cancer during the operation- If the resected lesion proves not to be cancer, the patient will remain as an enrolled patient but not evaluable and replaced by another patient
- •Established severe cardiovascular disease with estimated 5-year survival <10% based on Framingham risk score
- •Unstable angina or recent myocardial infarction (MI)/stroke within 6 months
研究组 & 干预措施
Arm I (Transfusion for Hgb less than 7 g/dL)
Patients undergo red blood cell transfusion if Hgb is less than 7 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.
干预措施: Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL) (Biological)
Arm I (Transfusion for Hgb less than 7 g/dL)
Patients undergo red blood cell transfusion if Hgb is less than 7 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.
干预措施: Computed Tomography (Procedure)
Arm I (Transfusion for Hgb less than 7 g/dL)
Patients undergo red blood cell transfusion if Hgb is less than 7 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.
干预措施: X-Ray Imaging (Procedure)
Arm I (Transfusion for Hgb less than 7 g/dL)
Patients undergo red blood cell transfusion if Hgb is less than 7 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm I (Transfusion for Hgb less than 7 g/dL)
Patients undergo red blood cell transfusion if Hgb is less than 7 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.
干预措施: Survey Administration (Other)
Arm I (Transfusion for Hgb less than 7 g/dL)
Patients undergo red blood cell transfusion if Hgb is less than 7 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.
干预措施: Pancreatectomy (Procedure)
Arm II (Transfusion for Hgb less than 9 g/dL)
Patients undergo red blood cell transfusion if Hgb is less than 9 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.
干预措施: Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL) (Biological)
Arm II (Transfusion for Hgb less than 9 g/dL)
Patients undergo red blood cell transfusion if Hgb is less than 9 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.
干预措施: Computed Tomography (Procedure)
Arm II (Transfusion for Hgb less than 9 g/dL)
Patients undergo red blood cell transfusion if Hgb is less than 9 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.
干预措施: X-Ray Imaging (Procedure)
Arm II (Transfusion for Hgb less than 9 g/dL)
Patients undergo red blood cell transfusion if Hgb is less than 9 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm II (Transfusion for Hgb less than 9 g/dL)
Patients undergo red blood cell transfusion if Hgb is less than 9 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.
干预措施: Survey Administration (Other)
Arm II (Transfusion for Hgb less than 9 g/dL)
Patients undergo red blood cell transfusion if Hgb is less than 9 g/dL while on study. Patients undergo CT scan, x ray imaging, and blood sample collection throughout the study.
干预措施: Pancreatectomy (Procedure)
结局指标
主要结局
Rate of Protocol adherence
时间窗: Up to 36 months post surgery
Will be measured as the proportion of patients who are enrolled in the study and do not experience major protocol
次要结局
- Length of stay in hospital and intensive care unit (ICU)(through study completion, an average of 1 year)
- Incidence of significant individual adverse events(Up to 36 months post operative)
- Health related quality of life(At preoperative visit, post operative period, months 1, 3, 6, 9, 12, 24, 27, 30, 33, 36)
- Proportion of patients transfused(Up to hospital discharge or post operative day 28)
- Number of blood products received(Up to hospital discharge or post operative day 28)