Trial Of Pathogen-reduced Cryoprecipitate vs. Cryoprecipitated AHF to Lower Operative Transfusions (TOP-CLOT): study...

Area of Science:

• Cardiovascular Surgery
• Hematology
• Critical Care Medicine

Background:

• Intraoperative hemorrhage in cardiac surgery is a significant risk factor for morbidity and mortality.
• Low fibrinogen levels correlate with increased bleeding severity and blood product transfusion requirements.
• Current fibrinogen replacement therapy (cryoprecipitated antihemophilic factor) has a delayed administration time due to frozen storage.

Purpose of the Study:

• To evaluate if earlier correction of hypofibrinogenemia with pathogen-reduced fibrinogen complex (IFC) reduces allogeneic blood product transfusions in cardiac surgery patients.
• To compare the efficacy of immediately available thawed IFC versus cryo AHF in managing acute bleeding during cardiac surgery.

Main Methods:

• A single-center, prospective, cluster randomized trial with an adaptive design.
• Patients undergoing cardiac surgery with acquired hypofibrinogenemia (FIBTEM A10 ≤ 10 mm) will be enrolled.
• Intervention assignment (IFC vs. cryo AHF) will be randomized in 1-month blocks.

Main Results:

• This section is not yet available as the trial is ongoing.

Conclusions:

• This trial aims to provide evidence on the clinical utility of readily available IFC for acute bleeding in cardiac surgery.
• The study will inform clinical practice regarding the optimal management of hypofibrinogenemia during cardiac procedures.