Pro-Con Debate

Fibrinogen Concentrate or Cryoprecipitate for Treatment of Acquired Hypofibrinogenemia in Cardiac Surgical Patients

Nadia B. Hensley, MD; Michael A. Mazzeffi, MD, MPH, MSc, FASA


Anesth Analg. 2021;133(1):19-28. 

In This Article

US Food and Drug Administration Requirements for Cryoprecipitate

US Food and Drug Administration (FDA) requirements for cryoprecipitate are outlined in the Code of Federal Regulations (CFR) Title 21, Section 640.5. In this document, the FDA describes the minimum factor VIII activity that is required for a single donor cryoprecipitate unit, which is 80 international units (IUs). When 5 single donor units are pooled together, this can be extrapolated to a minimum of 400 IU of factor VIII. The CFR further states that at least 4 cryoprecipitate units must be tested per month to determine the adequate factor VIII potency in any center that processes cryoprecipitate.