Red Blood Cell Transfusion Thresholds for Improved Quality of Life for Patients Undergoing a Pancreatectomy for Pancreatic Cancer

Open Label Randomized Trial of Blood Transfusions in Cancer Patients Following a Pancreatectomy: A Feasibility Study

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.

Study Overview

• Status: Terminated
• Conditions: Resectable Pancreatic Carcinoma
• Intervention / Treatment: Procedure: Biospecimen Collection; Other: Survey Administration; Procedure: X-Ray Imaging; Procedure: Computed Tomography; Biological: Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL); Procedure: Pancreatectomy; Biological: Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL)

Detailed Description

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.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo red blood cell transfusion if hemoglobin (Hgb) is less than 7 g/dL while on study.

ARM II: Patients undergo red blood cell transfusion if Hgb is less than 9 g/dL while on study.

Patients undergo computed tomography (CT) scan, x ray imaging, and blood sample collection throughout the study.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095-1406
      • University of California at Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection; Other: Survey Administration; Ancillary studies; Procedure: X-Ray Imaging; Undergo x-ray imaging; Other Names: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Radiographic Imaging, Radiography, RG, Static X-Ray, X-RAY, X-Ray, X-Ray, X-Ray, X-Ray; Procedure: Computed Tomography; Undergo CT scan; Other Names: CAT, CAT Scan, CAT scan, CAT Scan, Computed Axial Tomography, Computed Tomography, computed tomography; Biological: Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL); Receive conservative transfusion strategy (Hgb < 7 g/dL); Other Names: PRBC Transfusion; Procedure: Pancreatectomy; surgical removal of all or part of pancreas
Experimental: 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.	Procedure: Biospecimen Collection; Undergo blood sample collection; Other Names: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection; Other: Survey Administration; Ancillary studies; Procedure: X-Ray Imaging; Undergo x-ray imaging; Other Names: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Radiographic Imaging, Radiography, RG, Static X-Ray, X-RAY, X-Ray, X-Ray, X-Ray, X-Ray; Procedure: Computed Tomography; Undergo CT scan; Other Names: CAT, CAT Scan, CAT scan, CAT Scan, Computed Axial Tomography, Computed Tomography, computed tomography; Procedure: Pancreatectomy; surgical removal of all or part of pancreas; Biological: Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL); Receive liberal transfusion strategy (Hgb < 9 g/dL); Other Names: PRBC Transfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Protocol adherence	Will be measured as the proportion of patients who are enrolled in the study and do not experience major protocol	Up to 36 months post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health related quality of life	Will be assessed by Patient Reported Outcomes Measurement Information System (PROMIS)-29 v2.1. PROMIS, uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population. a higher T-score represents more of the concept being measured. For negatively-worded concepts like fatigue, a higher T-score represents greater fatigue and a lower T-score represents less fatigue. For positively-worded concepts like physical function, a higher T-score reflects higher (better) physical function and a lower T-score reflects lower (worse) physical function. For NIH Toolbox performance tests of cognitive, motor, and sensory function, a higher score indicates better performance.	At preoperative visit, post operative period, months 1, 3, 6, 9, 12, 24, 27, 30, 33, 36
Incidence of significant individual adverse events	Will include major adverse cardiovascular events (MACE), surgical site infection (SSI), surgical site occurrence (SSO), clinically-relevant postoperative pancreatic fistula (CR-POPF), hemorrhage, pneumonia, urinary tract infection (UTI), reoperation, readmission, and mortality. Safety and tolerability data will be summarized by treatment group. Adverse events will be tabulated by treatment group and will include the number of patients for whom the event occurred, the rate of occurrence, and the severity and relationship to study drug.	Up to 36 months post operative
Length of stay in hospital and intensive care unit (ICU)		through study completion, an average of 1 year
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

Collaborators and Investigators

• Sponsor: Jonsson Comprehensive Cancer Center
• Investigators: Principal Investigator: Edward Livingston, MD, University of California at Los Angeles

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2023
• Primary Completion (Actual): March 17, 2025
• Study Completion (Actual): March 17, 2025

Study Registration Dates

• First Submitted: April 12, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): June 10, 2025
• Last Update Submitted That Met QC Criteria: June 5, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: pancreatectomy, Transfusion
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 22-001796

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No