Red Blood Cell Transfusion Thresholds for Improved Quality of Life for Patients Undergoing a Pancreatectomy for Pancreatic Cancer
Key facts
- Who runs it
- Jonsson Comprehensive Cancer Center
- Where
- Los Angeles, United StatesSee the site
- Trial code
- Status
- Terminated
- Phase
- Early phase 1
- People taking part
- 1 person enrolled
- Started
- 10 Aug 2023
- Ended
- 17 Mar 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL)
- Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL)
- Computed Tomography
- X-Ray Imaging
- Biospecimen Collection
- Survey Administration
- Pancreatectomy
- Record updated
- 10 June 2025
- Why it stopped
- slow accrual
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 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
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
- Patients who are unable to receive or who refuse blood products
- Patients involved in an autologous pre-donation program
Where in United States
- University of California at Los AngelesLos Angeles, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Arm I (Transfusion for Hgb less than 7 g/dL)Treatment being tested
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.
Treatment: Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL), Computed Tomography, X-Ray Imaging, Biospecimen Collection, Survey Administration, and Pancreatectomy
- Arm II (Transfusion for Hgb less than 9 g/dL)Treatment being tested
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.
Treatment: Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL), Computed Tomography, X-Ray Imaging, Biospecimen Collection, Survey Administration, and Pancreatectomy
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Open Label Randomized Trial of Blood Transfusions in Cancer Patients Following a Pancreatectomy: A Feasibility Study
- Record updated
- 10 June 2025