POlysaccharide haemostat for WounD haEmatomas Reduction in Cardiac Implantable Electronic Devices procedures – A Randomised Controlled Trial
The number of patients recruited by Canberra Heart Rhythm: 58 with continuous enrollment
This study is an investigator-initiated, multi-centre, prospective, single blind, randomised trial.
SYNOPSIS OF THE STUDY:
Cardiac Implantable Electronic Device (CIED) therapy is a safe and effective therapy but is not without complications. Bleeding complications, which can potentially be preventable, are of concern as they significantly increase the risk of infection with subsequently increased morbidity and mortality. Arista™AH Absorbable Hemostat (Arista) is a novel powder, that has been shown in surgical settings to be safe, effective and result in significantly reduced haemostasis time and requirement for blood transfusion.
The aim of this study is to investigate the potential benefits of routine use of Arista in CIED implantation procedures. Participants will receive either standard of care, or standard of care in addition to the administration of Arista to the CIED pocket prior to skin closure. It is expected that participants who receive Arista will have a lower incidence of device haematomas post-implant. Participants will be followed up for 6 months post device implant.
The study aims to determine:
The efficacy of Arista AH in reducing of the incidence of acute and subacute device haematomas.
The efficacy of Arista AH use in achieving adequate haemostasis at conclusion of procedure.
The safety of routine Arista AH use in CIED implantation procedures.
The effect of routine Arista AH use on patient-centred outcome measures of peri-procedural comfort and overall satisfaction.
Inclusion Criteria
Patient is ≥18 years of age
Undergoing elective CIED procedure (i.e. de novo device implantation or pulse generator change or lead replacement or pocket revision)
Willing and able to comply with scheduled follow-up and study related activities
Exclusion Criteria
Unwilling or unable to provide informed consent
Prior history of, or ongoing CIED infection (i.e. undergoing device explant)
Receiving thrombolytic therapy (e.g. streptokinase, urokinase, t-PT) within 24 hours
Medical history of coagulopathy
Sensitivity to starch or starch-derived materials
Pregnancy