Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001156875
Ethics application status
Approved
Date submitted
16/07/2021
Date registered
27/08/2021
Date last updated
27/08/2021
Date data sharing statement initially provided
27/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
POlysaccharide haemostat for WounD haEmatomas Reduction in Cardiac Implantable Electronic Devices procedures – a Randomised Controlled Trial
Scientific title
POlysaccharide haemostat for WounD haEmatomas Reduction in Cardiac Implantable Electronic Devices procedures in Adults – a Randomised Controlled Trial
Secondary ID [1] 304811 0
Nil
Universal Trial Number (UTN)
Trial acronym
The POWDER-CIED RCT study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haematoma formation following cardiac implantable electronic devices 322875 0
Condition category
Condition code
Cardiovascular 320453 320453 0 0
Other cardiovascular diseases
Blood 320688 320688 0 0
Other blood disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 321180 0
Treatment: Devices
Comparator / control treatment
Standard of Care includes. compression, electro-cautery, and/or ligature and
guideline-directed management of oral anticoagulation (OAC) peri-operatively (as per The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation).
Control group
Active

Outcomes
Primary outcome [1] 328287 0
The incidence of pocket haematoma of grade 2 or greater. This is collected using clinical assessment using face-to-face follow-up.

Grade 2 haematomas extend beyond 2 cm of the device margin and/or cause considerable strain on the wound.

Grade 3 haematomas are those that require prolongation of hospitalization (defined as extended hospitalization or re-hospitalization for >24 hours, post index surgery, primarily due to hematoma) and/or requiring interruption of OAC (defined as reversal or intentional withholding, in response to pocket hematoma, resulting in sub-therapeutic anticoagulation for >24 hours).
Timepoint [1] 328287 0
Acute (pre-discharge) or subacute (within 6 weeks up to first device follow-up visit - primary endpoint.
Secondary outcome [1] 398365 0
Satisfactory haemostasis at conclusion of procedure according to clinician's response in a study-specific survey
Timepoint [1] 398365 0
Conclusion of procedure
Secondary outcome [2] 398366 0
The incidence of any haematoma; collectively and by grade. This is collected using clinical assessment using face-to-face follow-up.
Timepoint [2] 398366 0
Assessed at 3 timepoints:
- Predischarge
- First follow-up visit (within 6 weeks)
- At 6 months
Secondary outcome [3] 398367 0
The incidence of wound infection up to 6 months post procedure. This is collected using clinical assessment using face-to-face follow-up, or ascertained through telephone follow-up.
Timepoint [3] 398367 0
At any point up to 6 months
Secondary outcome [4] 398368 0
Safety endpoint of post-operative fever. Body temperature will be assessed clinically using a clinical-grade thermometer.
Timepoint [4] 398368 0
Predischarge (within 24 hours post implant)
Secondary outcome [5] 398369 0
Incidence of adverse events, defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in participants, users or other persons,. Examples include, but are not limited to, myocardial infarction, haemothorax, cardiac tamponade, and thromboembolic events (e.g. stroke, deep venous thrombosis, pulmonary embolism).
Assessed using medical records assessment and telephone follow-up.
Timepoint [5] 398369 0
At any point up to 6 months
Secondary outcome [6] 398370 0
Health-related quality of life (HRQoL) measures relating to patient comfort and satisfaction (assessed using the EQ-5D-5L tool).
Timepoint [6] 398370 0
Assessed at 3 timepoints:
- Predischarge
- First follow-up visit (within 6 weeks)
- At 6 months
Secondary outcome [7] 399246 0
Quantitative analysis of inflammatory markers (white cell count and c-reactive protein) using laboratory analysis of participants' blood.
Timepoint [7] 399246 0
Predischarge (within 24 hours post implant)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/09/2021
Actual
Date of last participant enrolment
Anticipated
1/08/2023
Actual
Date of last data collection
Anticipated
5/02/2024
Actual
Sample size
Target
1032
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,SA,VIC
Recruitment hospital [1] 19994 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 19995 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [3] 19996 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 34702 0
5000 - Adelaide
Recruitment postcode(s) [2] 34703 0
3050 - Parkville
Recruitment postcode(s) [3] 34704 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 309181 0
Commercial sector/Industry
Name [1] 309181 0
Becton, Dickinson and Company
Country [1] 309181 0
United States of America
Primary sponsor type
University
Name
The University of Adelaide
Address
North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 310140 0
None
Name [1] 310140 0
Address [1] 310140 0
Country [1] 310140 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309039 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 309039 0
Royal Adelaide Hospital
Port Road, Adelaide SA 5000
Ethics committee country [1] 309039 0
Australia
Date submitted for ethics approval [1] 309039 0
Approval date [1] 309039 0
05/07/2021
Ethics approval number [1] 309039 0
2021/HRE00035

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112746 0
Prof Prashanthan Sanders
Address 112746 0
Cardiovascular Centre
62 Beulah Road, Norwood SA 5067
Country 112746 0
Australia
Phone 112746 0
+61 8 8222 2723
Fax 112746 0
Email 112746 0
[email protected]
Contact person for public queries
Name 112747 0
Miss Ellen Lyrtzis
Address 112747 0
Cardiovascular Centre
62 Beulah Road, Norwood SA 5067
Country 112747 0
Australia
Phone 112747 0
+61 883139000
Fax 112747 0
Email 112747 0
[email protected]
Contact person for scientific queries
Name 112748 0
Dr Kadhim Kadhim
Address 112748 0
Cardiovascular Centre
62 Beulah Road, Norwood SA 5067
Country 112748 0
Australia
Phone 112748 0
+61 0883139000
Fax 112748 0
Email 112748 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12761Ethical approval    382422-(Uploaded-04-08-2021-22-54-57)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.