None listed
Conditions
Brief summary
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.
Interventions
Arista AH is a topical absorbable haemostatic powder. Adult patients undergoing planned Cardiac Implantable Electronic Device (CIED) implantation or generator replacement will be considered for the study. If eligible they will be randomised in a 1:1 ratio to Conventional Arm or Intervention Arm.
In the intervention Arm participants will receive standard of care treatment in addition to Arista AH 1-3g powder applied to the CIED pocket by the operator, prior to skin closure. The amount of powder
Arista AH is a topical absorbable haemostatic powder. Adult patients undergoing planned Cardiac Implantable Electronic Device (CIED) implantation or generator replacement will be considered for the study. If eligible they will be randomised in a 1:1 ratio to Conventional Arm or Intervention Arm. In the intervention Arm participants will receive standard of care treatment in addition to Arista AH 1-3g powder applied to the CIED pocket by the operator, prior to skin closure. The amount of powder used will be at the operator's discretion, ensuring to adequately cover the following areas with Arista: - Any visible micro-bleeders or areas of blood ooze - Around venous access site - Directly onto any visible muscular layers if the fascia is compromised - Underneath the inner layer of skin where the CIED device will be placed The procedure operator will be the Principal Investigator or a delegate trained to perform the study specific procedure. The participant will be unaware of randomisation arm allocation. Participants will be assessed pre-procedure (baseline), and post-procedure; pre-discharge, 1 month and 6 month. This will be in line with routine standard of care follow-up appointments. ARISTA is used in accordance with label directions and is being used as an adjunctive hemostat to control bleeding/oozing from the pocket.
Sponsors
The University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patient is equal to or greater than 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
Outcome results
None listed