26
Participants
Start Date
November 1, 2022
Primary Completion Date
September 17, 2024
Study Completion Date
December 15, 2024
Individualized HDR-approach
"Heparin concentration necessary to achieve target ACT \> 480 sec. calculated based on individual HDR-curve.~If HDR slope ˂80 s/IU/mL (reduced sensitivity to heparin), 1000 IU of AT concentrate (Antitrombin III Baxalta®, Takeda Pharma, Vallensbæk Strand, DK). Whole blood concentration of circulating heparin assessed by heparin assays. Additional heparin given as required. After weaning, protamine necessary to reverse circulating heparin calculated according to heparin-protamine titration measurement. After protamine, heparin reversal evaluated with low-range heparin-protamine titration cartridge and additional protamine given as required."
Conventional ACT-approach
"Initial Heparin 400 IU/kg (500 IU/kg if treated with heparin prior to surgery). ACT Assessment with Hemochron® Signature Elite (ITC, International Technidyne Corp., Edison, NJ, USA).~Additional heparin until ACT \> 480 sec. If ACT \< 480 sec. after despite repeated heparin supplement with 1000 IU of AT III concentrate. Target ACT \> 480 sec. during normothermic CPB, and target ACT \> 700 seconds during hypothermia After weaning, protamine 10mg/mL (0.7 mg of protamine/ 100 IU total heparin administered). Heparin reversal is evaluated with an activated partial thromboplastin (APTT). If APTT \> 40 seconds, additional protamine (25-50 mg i.v.)."
Aarhus University Hospital Skejby, Aarhus
Ivy susanne Modrau, MD
OTHER