IHPT-MiECC
Trial question
What is the role of individualized heparin monitoring and management in patients undergoing cardiac surgery with minimal invasive extracorporeal circulation?
Study design
Multi-center
Open label
RCT
Population
132 patients
Inclusion criteria: patients undergoing cardiac surgery with minimal invasive extracorporeal circulation
Key exclusion criteria: known blood disorder; contraindication to heparin administration
Interventions
N=undefined individualized heparin-protamine titration (use of Hemostasis Management System Plus device with 0.75:1 protamine-to-heparin ratio)
N=undefined conventional heparinization and reversal (use of Activated Coagulation Timer System Plus device with 0.75:1 protamine-to-heparin ratio)
Primary outcome
Total protamine dose used in coronary artery bypass grafting patients
118
163
163.0 mg
122.3 mg
81.5 mg
40.8 mg
0.0 mg
Individualized heparin-protamine
titration
Conventional heparinization and
reversal
Significant
decrease ▼
Significant decrease in total protamine dose used in CABG patients (118 mg vs. 163 mg; AD -45 mg, 95% CI -71.7 to -18.3)
Secondary outcomes
Significant decrease in total protamine dose used in non-CABG patients (151 mg vs. 197 mg; AD -46 mg, 95% CI -73.29 to -18.71)
Significant increase in heparin requirement in non-CABG patients (34539 IU vs. 29893 IU; AD 4646 IU, 95% CI 726.87 to 8565.13)
Conclusion
In patients undergoing cardiac surgery with minimal invasive extracorporeal circulation, individualized heparin-protamine titration was superior to conventional heparinization and reversal with respect to total protamine dose used in CABG patients.
Reference
Anna Gkiouliava, Helena Argiriadou, Polychronis Antonitsis et al. Individualized heparin monitoring and management reduces protamine requirements in cardiac surgery on minimal invasive extracorporeal circulation; A prospective randomized study. Perfusion. 2023 Sep 30:2676591231204284. Online ahead of print.
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