Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000478819
Ethics application status
Approved
Date submitted
9/02/2021
Date registered
21/04/2021
Date last updated
21/04/2021
Date data sharing statement initially provided
21/04/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to find the effect of different enoxaparin doses used on stroke occurrence after brain aneurysm coiling or stenting
Scientific title
Efficacy of single versus split dose enoxaparin post elective neurointervention in prevention of thromboembolic events in adults- a randomised study
Secondary ID [1] 303361 0
Royal Australian and New Zealand College of Radiologist Research Grant - 2020/RANZCR/022
Universal Trial Number (UTN)
Trial acronym
EPPICS II
Linked study record
EPPICS I - ACTRN12616001277437

EPPICS II is a follow up study of EPPICS I. Participants in EPPICS I were randomised into receiving heparin, enoxaparin single dose or enoxaparin split dose. As significantly more stable drug levels were found in the enoxaparin arms of EPPICS I, EPPICS II has been created to explore the efficacy of single vs split dose enoxaparin.

Health condition
Health condition(s) or problem(s) studied:
Intracranial aneurysm 320623 0
Stroke 320624 0
Condition category
Condition code
Stroke 318478 318478 0 0
Ischaemic
Stroke 319396 319396 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Subcutaneous administration of enoxaparin post endovascular procedures for intracranial aneurysms
Patients are randomised into two arms with doses of either 1mg/kg 12 hours apart, or 1.5mg/kg as a single dose
Administered subcutaneously immediately after the procedure, and 12 hours later if applicable
All doses will be recorded in patient's medication chart
Intervention code [1] 319670 0
Treatment: Drugs
Comparator / control treatment
Control group - patients who receive 1.5mg/kg of enoxaparin after endovascular procedures
Control group
Dose comparison

Outcomes
Primary outcome [1] 326435 0
The proportion of patients per group who develop thromboembolic events detected as lesions on DWI MRI within 48 hours post endovascular treatment of intracranial aneurysms
Timepoint [1] 326435 0
At conclusion of study
Secondary outcome [1] 391482 0
The proportion of patients who experience a puncture site complication such as haematoma, vessel dissection or pseudoaneurysm formation. This is assessed clinically or radiologically with ultrasonography or computed tomography
Timepoint [1] 391482 0
At conclusion of study
Secondary outcome [2] 392679 0
Intraparenchymal haemorrhage. This is assessed with MRI scanning of the brain to look for susceptibility weighted lesions within 48 hours post procedure
Timepoint [2] 392679 0
At conclusion of study
Secondary outcome [3] 394375 0
Frequency of haemorrhage - major and minor
a. Major haemorrhage – A clinically overt haemorrhage resulting in a fall of more than 30 g/L in haemoglobin; or a retroperitoneal, intracranial or intraocular haemorrhage
b. Episodes of bleeding that were clinically overt but do not meet these criteria are considered minor haemorrhages
Timepoint [3] 394375 0
At conclusion of study

Eligibility
Key inclusion criteria
Patients deemed fit for an elective endovascular aneurysm treatment
Patients who require post procedure anticoagulation after intracranial endovascular aneurysm treatment. The criteria for post procedural anticoagulation are any of the following:
1) Placement of an Endovascular Device
2) Presence of procedural platelet aggregation
3) Increased risk of thromboembolic events due to
(3a) large area of coil exposure at aneurysm neck
(3b) loop protrusion into parent artery
Able to understand the project and provide voluntary consent and continued participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under 18 years of age (i.e. paediatric population)
Patients presenting with acute subarachnoid haemorrhage
Patients with significantly impaired renal function (eGFR < 30)
Patients not suitable for 3T MR imaging (e.g. pacemakers)
Pregnant women
Patients deemed not to require anti-coagulation

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelope containing instructions as to which arm, 1mg/kg or 1.5mg/kg, the patient is randomised to
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomised with randomiser in Microsoft Excel
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Sample size calculations were performed using a two-sided pooled Z test based on 80% power and equal number allocation to each group. An estimate of the proportion of patients with a new DWI lesion post procedure was derived from the EPPICS I study. EPPICS I found 0.64 of patients experienced a new DWI lesion post procedure in the enoxaparin 1mg/kg group. With a clinically meaningful absolute decrease of 0.25 and a type I error rate (a) of 0.05, 62 participants are required for each of the two arms. Therefore we aim to recruit a total of 124 participants.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
124
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18579 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 32953 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 307774 0
Charities/Societies/Foundations
Name [1] 307774 0
Royal Australian and New Zealand College of Radiologists
Country [1] 307774 0
Australia
Funding source category [2] 307775 0
Hospital
Name [2] 307775 0
Royal Brisbane and Women's Hospital
Country [2] 307775 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Butterfield St, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 308525 0
None
Name [1] 308525 0
Address [1] 308525 0
Country [1] 308525 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307795 0
Royal Brisbane and Women's Hospital Human Research Ethics Committee
Ethics committee address [1] 307795 0
Royal Brisbane and Women's Hospital
Executive Suites, Lower Ground Floor
Dr. James Mayne Building
Butterfield Street, Herston QLD 4029
Australia
Ethics committee country [1] 307795 0
Australia
Date submitted for ethics approval [1] 307795 0
Approval date [1] 307795 0
15/10/2020
Ethics approval number [1] 307795 0
HREC/2020/QRBW/67967

Summary
Brief summary
Small silent strokes are a known complication after endovascular procedures done to treat brain aneurysms. This is due to small clots that could form around the coils or stents used to treat the aneurysm. Blood thinners are given after such procedures to prevent this. This trial attempts to assess the efficacy of the blood thinner enoxaparin, as to whether it is better to give patients 1mg/kg or 1.5mg/kg doses after endovascular procedures for brain aneurysms.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 108522 0
Prof Alan Coulthard
Address 108522 0
Department of Radiology
Royal Brisbane and Women's Hospital
Butterfield St, Herston QLD 4029
Country 108522 0
Australia
Phone 108522 0
+61 7 36460932
Fax 108522 0
Email 108522 0
Alan.Coulthard@health.qld.gov.au
Contact person for public queries
Name 108523 0
Dr Ee Shern Liang
Address 108523 0
Department of Radiology
Royal Brisbane and Women's Hospital
Butterfield St, Herston QLD 4029
Country 108523 0
Australia
Phone 108523 0
+61 7 36460932
Fax 108523 0
Email 108523 0
dmi.research.rbwh@gmail.com
Contact person for scientific queries
Name 108524 0
Dr Ee Shern Liang
Address 108524 0
Department of Radiology
Royal Brisbane and Women's Hospital
Butterfield St, Herston QLD 4029
Country 108524 0
Australia
Phone 108524 0
+61 7 36460932
Fax 108524 0
Email 108524 0
dmi.research.rbwh@gmail.com

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
10448Study protocol    381366-(Uploaded-05-02-2021-11-36-57)-Study-related document.docx
10449Ethical approval    381366-(Uploaded-05-02-2021-11-37-11)-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.