Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000673246
Ethics application status
Approved
Date submitted
5/08/2009
Date registered
6/08/2009
Date last updated
6/08/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dextran in Carotid Endarterectomy Trial
Scientific title
A Multicentre, Randomised, Placebo contolled trial of intravenous 10% Dextran 40 (Rheomacrodex), in the Prevention of Stroke in Carotid Surgery
Universal Trial Number (UTN)
Trial acronym
DICE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carotid Endarterectomy and Thromboembolism 243413 0
Condition category
Condition code
Stroke 239714 239714 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administered at the induction of anaesthesia for carotid endarterectomy, the trial intervention consists of an initial bolus of 20ml of dextran 1 (promit) or normal saline placebo given intravenously followed by intravenous infusion of 10% dextran 40 or normal saline placebo at an infusion rate of 125 ml/hr for 4 hours then 42 ml/hr for a further 12 hours.
Intervention code [1] 237048 0
Treatment: Drugs
Intervention code [2] 237087 0
Prevention
Comparator / control treatment
10% Dextran 40 (rheomacrodex) verses placebo (normal saline)
Control group
Placebo

Outcomes
Primary outcome [1] 240507 0
Ipsilateral fatal and non-fatal stroke, hemispheric or retinal
Timepoint [1] 240507 0
At 30 days post-intervention
Primary outcome [2] 240508 0
Ipsilateral Transient Ischaemic Attack (TIA)
Timepoint [2] 240508 0
At 30 days post-intervention
Secondary outcome [1] 257065 0
Any non-fatal or fatal stroke
Timepoint [1] 257065 0
At 30 days post-intervention
Secondary outcome [2] 257066 0
Death due to any cause
Timepoint [2] 257066 0
At 30 days post-intervention
Secondary outcome [3] 257067 0
Unstable angina or non-fatal myocardial infarction
Timepoint [3] 257067 0
At 30 days post-intervention

Eligibility
Key inclusion criteria
Symptomatic or a symptomatic carotid artery atherosclerosis considered suitable for Carotid Endarterectomy (CEA) performed under either general or loco-regional anaesthesia.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Documented history of congestive cardiac failure New York Heart Association Functional Classification equal to or greater than 3 (NYHA=/>GD 3), unstable angina or acute myocardial infarction within 3 months of surgery.
Renal impairment as measured by a serum creatinine of greater than 0.20 mmol/l.
Thrombocytopaenia of less than 100,000/mm3.
Previous hypersensitivity to dextrans.
Concomitant ipsilateral balloon and/or stenting procedure with CEA.
Patients remaining on warfarin during surgery and those who will receive concomitant heparin therapy post-operatively are also excluded. Patients who are treated with warfarin (without heparin) may be included if the International Normalised Ratio (INR) on the day of surgery is below 1.5.
Lack of informed consent.
Combined CEA/Coronary Artery Bypass Grafts (CABGs) procedure.

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)
A central randomisation centre is located at the Austin Hospital Pharmacy Department. The Pharmacy Department at each centre will maintain an additional log of patient details and treatment allocation for purposes of cross checking or unblinding of patients in the event of a serious adverse outcome. Any patients who are randomised, but do not follow protocol for whatever reason, are still followed up by the intention-to-treat principle.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Following the informed consenting process, participants are assigned consecutively to next study allocation (treatment or placebo). The allocation log was generated using random number generating software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1412
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237445 0
Self funded/Unfunded
Name [1] 237445 0
Country [1] 237445 0
Australia
Primary sponsor type
Other Collaborative groups
Name
National Stroke Research Institute and John Hunter Health
Address
L1 Neurosciences Building,Heidelberg Repatriation Hospital, 300 Waterdale Road Heidelberg Heights, Victoria 3081
Country
Australia
Secondary sponsor category [1] 236936 0
None
Name [1] 236936 0
Address [1] 236936 0
Country [1] 236936 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239576 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 239576 0
Ethics committee country [1] 239576 0
Australia
Date submitted for ethics approval [1] 239576 0
Approval date [1] 239576 0
Ethics approval number [1] 239576 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29991 0
Address 29991 0
Country 29991 0
Phone 29991 0
Fax 29991 0
Email 29991 0
Contact person for public queries
Name 13238 0
Dennis Young
Address 13238 0
Trial Coordinator
National Stroke Research Institute
Level 1, Neurosciences Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights Vic 3081
Country 13238 0
Australia
Phone 13238 0
+61 3 9496 2648
Fax 13238 0
+61 3 9496 2650
Email 13238 0
dyoun@nsri.org.au
Contact person for scientific queries
Name 4166 0
Christopher Levi
Address 4166 0
First Floor, Hunter Rehabilitation Service Buiding, John Hunter Hospital Campus, Locked Bag No.1, Hunter Region Mail Centre, NSW 2310
Country 4166 0
Australia
Phone 4166 0
+61 2 4985 5593
Fax 4166 0
+61 2 4921 4833
Email 4166 0
Christopher.Levi@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.