POlysaccharide haemostat for WounD haEmatomas Reduction in Cardiac Implantable Electronic Devices procedures: Rationale and Design of the POWDER-CIED trial

Background An estimated 1.5 million patients are implanted with a Cardiac Implantable Electronic Device (CIED) annually, of which approximately 1 in 100 will develop a CIED-related infection. These infections are associated with high morbidity and mortality. One of the main risk factors of infection is the incidence of a post-procedural pocket hematoma. Topical plant-based microporous polysaccharide hemosphere (MPH) particles have successfully been used in surgical settings to improve haemostasis and may be useful to reduce the incidence of pocket hematoma after CIED implantation. Objective To evaluate whether the routine use of MPH powder (Arista™ AH) is superior to standard of care to reduce the incidence of pocket hematoma in patients undergoing elective CIED procedures. Methods The POWDER-CIED trial is a phase 4, multicentre, randomized, controlled trial. The patient and assessors will be blinded to the treatment allocation. This trial will include 1032 patients scheduled for a CIED implantation, upgrade, or revision. Participants will be randomized 1:1 to standard of care or standard of care plus Arista™ AH. The primary endpoint will be the incidence of grade 2 or 3 pocket hematoma occurring within 6 weeks of the procedure. Safety endpoints will include inflammatory markers and incidence of CIED infections. Additionally, patient-related outcome measures will be collected. Conclusion The findings of this trial may add an additional tool in the armamentarium of operators to reduce the incidence of pocket hematoma and subsequent risk of CIED-related infections.