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

NCT05841706 | Terminated Early Phase 1 DMC FDA Drug

• 1 other identifier: 22-001796
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Resectable Pancreatic Carcinoma

Keywords

pancreatectomy, Transfusion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Health related quality of life

  At preoperative visit, post operative period, months 1, 3, 6, 9, 12, 24, 27, 30, 33, 36

• Incidence of significant individual adverse events

  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

Study Arms (2)

Arm I (Transfusion for Hgb less than 7 g/dL)

EXPERIMENTAL

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.

Biological: Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL); Procedure: Computed Tomography; Procedure: X-Ray Imaging; Procedure: Biospecimen Collection; Other: Survey Administration; Procedure: Pancreatectomy

Arm II (Transfusion for Hgb less than 9 g/dL)

EXPERIMENTAL

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.

Biological: Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL); Procedure: Computed Tomography; Procedure: X-Ray Imaging; Procedure: Biospecimen Collection; Other: Survey Administration; Procedure: Pancreatectomy

Interventions

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

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

Also known as: PRBC Transfusion

Arm I (Transfusion for Hgb less than 7 g/dL)

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

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

Also known as: PRBC Transfusion

Arm II (Transfusion for Hgb less than 9 g/dL)

Computed Tomography PROCEDURE

Undergo CT scan

Also known as: CAT, CAT Scan, CAT scan, CAT Scan, Computed Axial Tomography, Computed Tomography, computed tomography

Arm I (Transfusion for Hgb less than 7 g/dL); Arm II (Transfusion for Hgb less than 9 g/dL)

X-Ray Imaging PROCEDURE

Undergo x-ray imaging

Also known as: 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

Arm I (Transfusion for Hgb less than 7 g/dL); Arm II (Transfusion for Hgb less than 9 g/dL)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection

Arm I (Transfusion for Hgb less than 7 g/dL); Arm II (Transfusion for Hgb less than 9 g/dL)

Survey Administration OTHER

Ancillary studies

Arm I (Transfusion for Hgb less than 7 g/dL); Arm II (Transfusion for Hgb less than 9 g/dL)

Pancreatectomy PROCEDURE

surgical removal of all or part of pancreas

Arm I (Transfusion for Hgb less than 7 g/dL); Arm II (Transfusion for Hgb less than 9 g/dL)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead

Study Sites (1)

University of California at Los Angeles

Los Angeles, California, 90095-1406, United States

Location

MeSH Terms

Interventions

Hemoglobins; X-Rays; Specimen Handling; Pancreatectomy

Intervention Hierarchy (Ancestors)

Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globins; Hemeproteins; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Digestive System Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Edward Livingston, MD

  University of California at Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 3, 2023
• Study Start: August 10, 2023
• Primary Completion: March 17, 2025
• Study Completion: March 17, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Locations

US (1)