Effect Of Warmer On Blood Integrity
Posted Date: Feb 16, 2023
- Investigator: Jose Cancelas
- Type of Study: Device
The °M WARMER SYSTEM by MEQU is designed to heat infusion solutions to around body temperature prior to patient infusion. This study is designed to address questions from the US Food and Drug Administration (FDA) regarding changes to Whole Blood (WB) due to exposure to the °M WARMER SYSTEM. The purpose of this study is to evaluate if any significant clinically relevant changes to WB occur due to exposure to the test device during infusion. The US FDA has provided guidance on the testing conditions and requirements for this study. Testing will involve an acute exposure of the Whole Blood to the device at intended infusion parameters with special attention to hemolysis and platelet count in whole blood run through the MEQU blood warmer.
Criteria:
Subjects Over 16 Years Old Who Fulfill Fda, Aabb And Hoxworth Blood Center Criteria For Whole Blood Donation. Blood Units Are Deidentified And Are Purchased From Hoxworth Blood Center.
Keywords:
Erythrocyte, Platelet
For More Information:
Jose A Cancelas
15135581324
jose.cancelas@uc.edu