Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000240741
Ethics application status
Approved
Date submitted
25/02/2013
Date registered
28/02/2013
Date last updated
28/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevention of Deep Vein Thrombosis (DVT) in Patients undergoing Total Knee Replacement (TKR)Surgery with Low Molecular Weight Heparin (LMWH) or outpatient Calf Compression Device (CCD) after a short course of LMWH: a randomized prospective study
Scientific title
Prevention of Deep Vein Thrombosis (DVT) in Patients undergoing Total Knee Replacement (TKR)Surgery
Secondary ID [1] 281982 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep Venous Thrombosis 288411 0
Condition category
Condition code
Blood 288762 288762 0 0
Clotting disorders
Blood 288809 288809 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The usual practice of low molecular heparin therapy after orthopedic surgery to reduce risk of DVT and PE remains controversial in terms of length of therapy. This study is aimed at answering this question by reducing the length of therapy from 2 weeks to 1 week, without compromising safety in terms of increasing risk of clotting complications. The usual therapy involves enoxaparim 0.5 mg/kg,daily, commencing 8-12 hours post op, given subcutaneously. The only difference between the study groups was the length of the therapy but given daily.
Intervention code [1] 286597 0
Treatment: Drugs
Comparator / control treatment
Standard therapy (Control, 2 weeks of low molecular heparin) vs study group (1week of low molecular heparin), given daily, subcutaneously.
Control group
Dose comparison

Outcomes
Primary outcome [1] 288950 0
No difference between the two groups in terms of clotting episodes post operation, with a 3 month follow up
Method of assessment includes post operative day 5, venous doppler study of the treated limb as well as clinical assessments. In case of an abnormal venous doppler study indicating DVT, then pulmonary CT angiogram was performed to assess any PE.
Timepoint [1] 288950 0
Patients recruited over a 2 year period and followed up for 3 months and in case of any complications, 12 months, post op
Secondary outcome [1] 301421 0
Leg swelling and pain;
Assessed using pain score charts and calf measurements
Timepoint [1] 301421 0
total of 3 months of followup post op if no complications. In case of any complications then12 months of follow up.
Secondary outcome [2] 301466 0
hospital length of stay;
Using Date of admission and date of discharge and in case of readmission required, added to the total days of hospitalisation
Timepoint [2] 301466 0
Total of 3 months of followup
Secondary outcome [3] 301467 0
Wound infection
Using temperature charts, clinical assessment of wound and any concerns full blood count and CRP readings.
Timepoint [3] 301467 0
Total of 3 months of followup

Eligibility
Key inclusion criteria
age 18-90
no personal/family hx thrombophilia
BMI <35
english speaking
no anti-coagulation for other reasons
no acute clotting problem
undergoing elective total knee replacement surgery
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
age <18, >90
BMI >35
known history of thrombophilia
already on anti-coagulation
active malignancy or bleeding disorders
unfit to undergo surgical procedure (TKR)

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)
participants invited by questionnaire. Those eligible and willing consented. Upon arrival for their operation, allocated (by randomised computer allocation) to a treatment group (standard therapy LMWH or short course LMWH therapy). Clinicians then went ahead and treated patients based on their allocation to a particular treatment group.
The trial coordinator was the person who determined if the patient was eligible for inclusion in the trial and was unaware, when this decision was made, to which group the subject would be allocated. It was allocated by randomisation by computer ( computerised sequence generation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer matching for randomisation (computerised sequence generation)
blinding of patients and clinicians prior to treatment group allocation.
Stratified allocation was not deemed necessaty for this study.
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
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Fisher's exact tests
acceptable group treatment difference of 15% based on previous literature to calculate CI 95%

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 670 0
St George Private Hospital - Kogarah
Recruitment hospital [2] 679 0
Figtree Private Hospital - Figtree
Recruitment postcode(s) [1] 6407 0
2217 - Kogarah
Recruitment postcode(s) [2] 6408 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 286795 0
Self funded/Unfunded
Name [1] 286795 0
A/Prof. Raj Ramakrishna
Country [1] 286795 0
Australia
Primary sponsor type
Other
Name
Southern Sydney Hematology
Address
1 Derby Street,
Kogarah, NSW
2217
Country
Australia
Secondary sponsor category [1] 285586 0
None
Name [1] 285586 0
Address [1] 285586 0
Country [1] 285586 0
Australia
Other collaborator category [1] 277304 0
Other Collaborative groups
Name [1] 277304 0
Southern Haematology Cancer Research Institute
Address [1] 277304 0
35 Denison Street
Wollongong NSW 2500
Country [1] 277304 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288862 0
Human Rights and Ethics committe
Ethics committee address [1] 288862 0
SEHHREC
St.George Public hospital
Belgrave street
Kogarah NSW 2217
Ethics committee country [1] 288862 0
Australia
Date submitted for ethics approval [1] 288862 0
Approval date [1] 288862 0
23/11/2004
Ethics approval number [1] 288862 0
04/64 (SEHHREC)

Summary
Brief summary
This study hypothesises that shorter duration low molecular weight therpay is as effective as standard therapy in post operative orthopaedic DVT prophylaxis. There will be no significant difference in the incidence of post operative thrombotic events such as DVTs and PE. There mat be added advantages of reduced leg swelling and hence pain with the use of mobile calf compressor device as an outpatient.
Trial website
Trial related presentations / publications
There are various published data on the use of a shorter course of LMWH but there are no uniform guidelines developed as the evidence generated lacked clarity. This prompted this study which also aimed at assessing the use of post op outpatient calf compressor to reduce leg swelling and hence pain and improve mobility.
Public notes

Contacts
Principal investigator
Name 37970 0
A/Prof Raj Ramakrishna
Address 37970 0
1 Derby Street
Kogarah
NSW
2217
Country 37970 0
Australia
Phone 37970 0
+61-2 9553 1272
Fax 37970 0
Email 37970 0
[email protected]
Contact person for public queries
Name 37971 0
Dr Sarika Gupta
Address 37971 0
1 Derby Street
Kogarah
NSW
2217
Country 37971 0
Australia
Phone 37971 0
+61-2 9553 1272
Fax 37971 0
Email 37971 0
[email protected]
Contact person for scientific queries
Name 37972 0
A/Prof Raj Ramakrishna
Address 37972 0
1 Derby Street
Kogarah
NSW
2217
Country 37972 0
Australia
Phone 37972 0
+61-2 9553 1272
Fax 37972 0
Email 37972 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

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

Documents added automatically
No additional documents have been identified.