NCT05841706

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

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Arm I Packed Red Blood Cell Transfusion (Hgb < 7 g/dL)	Receive conservative transfusion strategy (Hgb \< 7 g/dL)
BIOLOGICAL	Arm II Packed Red Blood Cell Transfusion (Hgb < 9 g/dL)	Receive liberal transfusion strategy (Hgb \< 9 g/dL)
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	X-Ray Imaging	Undergo x-ray imaging
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
OTHER	Survey Administration	Ancillary studies
PROCEDURE	Pancreatectomy	surgical removal of all or part of pancreas

Timeline

• Start date: 2023-08-10
• Primary completion: 2025-03-17
• Completion: 2025-03-17
• First posted: 2023-05-03
• Last updated: 2025-06-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study