Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000147583
Ethics application status
Approved
Date submitted
10/04/2006
Date registered
27/04/2006
Date last updated
27/04/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Individualised compared with conventional dosing of enoxaparin
Scientific title
A prospective, randomised study to investigate if a patient-individualised dose regimen of enoxaparin reduces the incidence of bleeding and bruising as compared to conventional dosing in patients with ACS, AF, DVT and PE.
Universal Trial Number (UTN)
Trial acronym
i-ENOX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute coronary syndromes 1116 0
Deep vein thrombosis 1117 0
Pulmonary embolism 1118 0
Atrial fibrillation 1119 0
Condition category
Condition code
Cardiovascular 1196 1196 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be identified and consented by an investigator before or immediately after the first dose of enoxaparin. Patients will be randomised (using a randomisation table). The individualised arm (active) will recieve enoxaparin according to a new dosing strategy. The new dose strategy has been developed from two previous studies and uses lean body weight as the weight descriptor for dosing in obese (>100kg) patients (as opposed to the normal total body weight dosing). Patients with renal impairment will be dose reduced according to their renal function. All doses will be subcutaneous. The study started in May 2004 and will run for approximately 2 years, however an interim analysis was initiated in December 2005 and recruitment has not restarted (pending results). The study is suitably powered to 120 patients.
Intervention code [1] 977 0
Treatment: Drugs
Comparator / control treatment
Patients in the control arm will recieve enoxaparin as per usual clinical practice and at the advice of the treating physician (subcutaneously).
Control group
Dose comparison

Outcomes
Primary outcome [1] 1625 0
The total number of patients with a bleeding event. Each patient will be assessed by a nurse blinded to the treatment arm. This nurse will also review patient medical notes for any documentation of a bleeding event (for example overnight). Assessment will be daily until the last day of therapy (last dose of enoxaparin). The treating team will cease enoxaparin at a time suitable to them (usual practice will not be inhibited). The primary investigator will analyse all data.
Timepoint [1] 1625 0
Assessment will be daily until the last day of therapy (last dose of enoxaparin). The treating team will cease enoxaparin at a time suitable to them (usual practice will not be inhibited).
Secondary outcome [1] 2911 0
The total number of patients with a bleeding event (primary endpoint) or a major bruising event. A major bruisng event will be described as any bruise with a surface area greater thna 20cm2
Timepoint [1] 2911 0
A blinded nurse will review each patient daily (total body assessment) and measure the size and location of every bruise.

Eligibility
Key inclusion criteria
Any patient (male or female) initiated or about to be initiated on treatment doses of enoxaparin.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, anticoagulation in the past 7 days, abnormal liver function test (more than twice the usual range).

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)
An investigator, blinded to randomisation, will identify and consent the patients. Allocation to treatment arm involves contacting the holder of the randomisation table who is at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The patient and the assessing nurse will be blinded to the treatment arm. The investigator and treating team will be aware of the randomisation after consent by the patient
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1310 0
Government body
Name [1] 1310 0
Queensland hospitals drug advisory committee
Country [1] 1310 0
Australia
Primary sponsor type
Government body
Name
QHDAC
Address
Country
Australia
Secondary sponsor category [1] 1157 0
Charities/Societies/Foundations
Name [1] 1157 0
Society of Hospital Pharmacists of Australia
Address [1] 1157 0
Country [1] 1157 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2639 0
Royal Brisbane & Women's hospital Human Ethics Research committee
Ethics committee address [1] 2639 0
Ethics committee country [1] 2639 0
Australia
Date submitted for ethics approval [1] 2639 0
Approval date [1] 2639 0
Ethics approval number [1] 2639 0
2003/083

Summary
Brief summary
The aim of this study is to see if a new dosing regimen of enoxaparin (an anticoagulant used in the treatment of heart attacks, deep vein thrombosis and pulmonary embolism) if safer than the current method of dosing (designed by the drug company). Patients will agree on being part of the study and then treated using one of the two methods (they will be unaware which group they will be in). The number of bleeding events and large bruises will be recorded for every patient. The two methods of dosing can then be compared at the end of the study to see which one has caused the least bleeding/bruising events). It is hope that the new dosing method will result in less events.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35619 0
Address 35619 0
Country 35619 0
Phone 35619 0
Fax 35619 0
Email 35619 0
Contact person for public queries
Name 10166 0
Michael Barras
Address 10166 0
Pharmacy Department
Royal Brisbane and Women's Hospital
Brisbane QLD 4029
Country 10166 0
Australia
Phone 10166 0
+61 7 36368355
Fax 10166 0
+61 7 36361532
Email 10166 0
[email protected]
Contact person for scientific queries
Name 1094 0
Michael Barras
Address 1094 0
Pharmacy Department
Royal Brisbane and Women's Hospital
Brisbane QLD 4029
Country 1094 0
Australia
Phone 1094 0
+61 7 36368355
Fax 1094 0
+61 7 36361532
Email 1094 0
[email protected]

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

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