Purpose of this Study
This study uses a system called Hemanext ONE that keeps red blood cells in low oxygen. The study lasts about fourteen months. During the study, you will receive two kinds of blood transfusions. One kind uses low oxygen blood, and the other uses regular blood. The order is chosen by chance. Each type of transfusion lasts six months, with a two month break in between. At each visit, doctors will check your vital signs, do blood tests, and ask how you are feeling. There is also an optional visit one day after a transfusion for extra blood tests.
Who Can Participate?
Eligibility
People can join this study if they have a blood cancer and need regular blood transfusions. They must also be able to have a physical exam and share their medical history during screening, including their height, weight, medicines, and vital signs.
Age Range
18-100
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is being done to find out if a new way of storing blood, called the Hemanext ONE system, helps red blood cells stay healthier. Researchers want to see if this new method makes the blood work better and maybe reduces the number of transfusions a person needs. The study compares this new type of stored blood with the regular blood that is used today.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
A Multi-Center, Randomized, Controlled Cross-Over Study to Evaluate the Safety and Effectiveness of Hypoxic Red Blood Cells Processed with the Hemanext ONE® System versus Conventional Red Blood Cells in Patients with Transfusion-Dependent heamatological malignancies
Principal Investigator
Carlos
Decastro
Protocol Number
PRO00119317
NCT ID
NCT06685848
Phase
N/A
Enrollment Status
Pending Open to Enrollment