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Red Blood Cell Transfusions for Pancreatic Cancer

Phase < 1

Recruiting

Led By Edward Livingston, MD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male or female >= 18 years of age at Visit 1

CT evidence of a mass in the pancreas consistent with cancer

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether giving more red blood cell transfusions to patients undergoing pancreatic cancer surgery can improve their quality of life. Pancreatic cancer surgery can cause a lot of blood loss, which can

Who is the study for?

This trial is for adults over 18 with CT evidence of pancreatic cancer and a tissue diagnosis confirming the disease. Candidates should be evaluated as suitable for pancreatic surgery and must provide written consent to participate.

What is being tested?

The study tests two different red blood cell transfusion strategies (using lower or higher hemoglobin levels as triggers) in patients undergoing pancreatectomy for pancreatic cancer, aiming to see which improves quality of life.

What are the potential side effects?

Possible side effects from receiving blood transfusions include allergic reactions, fever, iron overload, lung injury, and infections. The risks vary depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My CT scan shows a mass in the pancreas that may be cancer.

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My doctors think surgery to remove my pancreas is possible.

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My cancer was confirmed by a tissue test before or after surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at preoperative visit, post operative period, months 1, 3, 6, 9, 12, 24, 27, 30, 33, 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at preoperative visit, post operative period, months 1, 3, 6, 9, 12, 24, 27, 30, 33, 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and at preoperative visit, post operative period, months 1, 3, 6, 9, 12, 24, 27, 30, 33, 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of Protocol adherence

Secondary study objectives

Health related quality of life

Incidence of significant individual adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (Transfusion for Hgb less than 9 g/dL)Experimental Treatment6 Interventions

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 II: Arm I (Transfusion for Hgb less than 7 g/dL)Experimental Treatment6 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pancreatectomy

2012

Completed Phase 2

~160

Computed Tomography

2017

Completed Phase 2

~2790