Trial Title:
Red Blood Cell Transfusion Thresholds for Improved Quality of Life for Patients Undergoing a Pancreatectomy for Pancreatic Cancer
NCT ID:
NCT05841706
Condition:
Resectable Pancreatic Carcinoma
Conditions: Official terms:
Pancreatic Neoplasms
Conditions: Keywords:
pancreatectomy, Transfusion
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL)
Description:
Receive conservative transfusion strategy (Hgb < 7 g/dL)
Arm group label:
Arm I (Transfusion for Hgb less than 7 g/dL)
Other name:
PRBC Transfusion
Intervention type:
Biological
Intervention name:
Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL)
Description:
Receive liberal transfusion strategy (Hgb < 9 g/dL)
Arm group label:
Arm II (Transfusion for Hgb less than 9 g/dL)
Other name:
PRBC Transfusion
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Arm I (Transfusion for Hgb less than 7 g/dL)
Arm group label:
Arm II (Transfusion for Hgb less than 9 g/dL)
Other name:
CAT, CAT Scan, CAT scan, CAT Scan, Computed Axial Tomography, Computed Tomography, computed tomography
Intervention type:
Procedure
Intervention name:
X-Ray Imaging
Description:
Undergo x-ray imaging
Arm group label:
Arm I (Transfusion for Hgb less than 7 g/dL)
Arm group label:
Arm II (Transfusion for Hgb less than 9 g/dL)
Other name:
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
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Arm I (Transfusion for Hgb less than 7 g/dL)
Arm group label:
Arm II (Transfusion for Hgb less than 9 g/dL)
Other name:
Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Ancillary studies
Arm group label:
Arm I (Transfusion for Hgb less than 7 g/dL)
Arm group label:
Arm II (Transfusion for Hgb less than 9 g/dL)
Intervention type:
Procedure
Intervention name:
Pancreatectomy
Description:
surgical removal of all or part of pancreas
Arm group label:
Arm I (Transfusion for Hgb less than 7 g/dL)
Arm group label:
Arm II (Transfusion for Hgb less than 9 g/dL)
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California at Los Angeles
Address:
City:
Los Angeles
Zip:
90095-1406
Country:
United States
Status:
Recruiting
Contact:
Last name:
Sarahmay Sanchez
Phone:
310-794-0283
Email:
sosanchez@mednet.ucla.edu
Contact backup:
Last name:
Melissa Arevalo
Phone:
310-794-0283
Email:
MFArevalo@mednet.ucla.edu
Start date:
August 10, 2023
Completion date:
April 30, 2026
Lead sponsor:
Agency:
Jonsson Comprehensive Cancer Center
Agency class:
Other
Source:
Jonsson Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05841706
