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

a study on Pancreatic Cancer Blood Transfusion Pancreatic Neoplasms

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Edward Livingston, MD (ucla)

Description

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.

Official Title

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

Details

PRIMARY OBJECTIVE:

  1. The primary objective for this pilot study is protocol adherence for the transfusion study we propose for pancreatectomy patients.

SECONDARY OBJECTIVES:

  1. 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.

Keywords

Resectable Pancreatic Carcinoma, pancreatectomy, Transfusion, Pancreatic Neoplasms, 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, Pancreatectomy, Transfusion for Hgb less than 7 g/dL, Transfusion for Hgb less than 9 g/dL

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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

Location

  • University of California at Los Angeles accepting new patients
    Los Angeles California 90095-1406 United States

Lead Scientist at University of California Health

  • Edward Livingston, MD (ucla)
    HS Clinical Professor, Surgery, Medicine. Authored (or co-authored) 283 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Jonsson Comprehensive Cancer Center
ID
NCT05841706
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 10 study participants
Last Updated