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

NCT ID: NCT05841706

Last Updated: 2025-06-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2025-03-17

Brief Summary

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.

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.

Conditions

Resectable Pancreatic Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL)

Intervention Type: BIOLOGICAL

Receive conservative transfusion strategy (Hgb \< 7 g/dL)

Computed Tomography

Intervention Type: PROCEDURE

Undergo CT scan

X-Ray Imaging

Intervention Type: PROCEDURE

Undergo x-ray imaging

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood sample collection

Survey Administration

Intervention Type: OTHER

Ancillary studies

Pancreatectomy

Intervention Type: PROCEDURE

surgical removal of all or part of pancreas

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.

Group Type: EXPERIMENTAL

Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL)

Intervention Type: BIOLOGICAL

Receive liberal transfusion strategy (Hgb \< 9 g/dL)

Computed Tomography

Intervention Type: PROCEDURE

Undergo CT scan

X-Ray Imaging

Intervention Type: PROCEDURE

Undergo x-ray imaging

Biospecimen Collection

Intervention Type: PROCEDURE

Undergo blood sample collection

Survey Administration

Intervention Type: OTHER

Ancillary studies

Pancreatectomy

Intervention Type: PROCEDURE

surgical removal of all or part of pancreas

Interventions

Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL)

Receive conservative transfusion strategy (Hgb \< 7 g/dL)

Intervention Type: BIOLOGICAL

Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL)

Receive liberal transfusion strategy (Hgb \< 9 g/dL)

Intervention Type: BIOLOGICAL

Computed Tomography

Undergo CT scan

Intervention Type: PROCEDURE

X-Ray Imaging

Undergo x-ray imaging

Intervention Type: PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Intervention Type: PROCEDURE

Survey Administration

Ancillary studies

Intervention Type: OTHER

Pancreatectomy

surgical removal of all or part of pancreas

Intervention Type: PROCEDURE

Other Intervention Names

PRBC Transfusion; PRBC Transfusion; CAT, CAT Scan, CAT scan, CAT Scan, Computed Axial Tomography, Computed Tomography, computed tomography; 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; Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Livingston, MD

Role: PRINCIPAL_INVESTIGATOR

University of California at Los Angeles

Locations

University of California at Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

22-001796

Identifier Type: -

Identifier Source: org_study_id