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Trial registered on ANZCTR


Registration number
ACTRN12619000907145
Ethics application status
Approved
Date submitted
11/06/2019
Date registered
27/06/2019
Date last updated
27/06/2019
Date data sharing statement initially provided
27/06/2019
Date results information initially provided
27/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prophylactic anticoagulant use in weight loss surgical patients
Scientific title
Prophylactic enoxaparin use and outcomes in obese patients undergoing laparoscopic adjustable gastric band surgery
Secondary ID [1] 298470 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Morbid Obesity 313237 0
Gastric banding 313238 0
Condition category
Condition code
Diet and Nutrition 311678 311678 0 0
Obesity
Surgery 311886 311886 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
No intervention was done. Drug dosing practice of enoxaparin and outcomes (venous thromboembolism and major bleed) were accessed in Laparoscopic adjustable gastric band patients. Patients were followed-up retrospectively from digital medical record for 90 days to observe any venous thromboembolism and major bleed incidence.

There were 2 cases venous thromboembolism identified.


Data was collected from year 2013-2017
Intervention code [1] 314712 0
Diagnosis / Prognosis
Comparator / control treatment
No compratator Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 320378 0
Venous thromboembolism
Timepoint [1] 320378 0
90 days of post-surgery follow-up from digital medical records.

One VTE happened 35th-day post-surgery and second happened 60th-day post-surgery.
Primary outcome [2] 320551 0
Major bleeding incidences.
Timepoint [2] 320551 0
90 days of post-surgery follow-up from digital medical records.

No major bleeding incident was noted
Secondary outcome [1] 371583 0
Nil
Timepoint [1] 371583 0
Nil

Eligibility
Key inclusion criteria
A retrospective cohort study was conducted of adult (age greater than or equal to 18 years) obese patients (BMI more than or equal to 30 kg/m2) who underwent primary and revisional bariatric surgery at the Royal Hobart Hospital (RHH) and the Hobart Private Hospital (HPH), from 1 Jan 2013 to 31 Dec 2017
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded from the study if they were on regular anticoagulant or vitamin K therapy, underwent a concurrent surgical procedure (e.g. hysterectomy), or had an established congenital or acquired bleeding disorder, varicose veins, renal impairment with an estimated glomerular filtration rate < 60 mL/min/1.73m2, prior heparin-induced thrombocytopaenia, haemorrhagic stroke within the previous 3 months, other surgery within the previous 3 months, or if relevant information was missing.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 303013 0
Self funded/Unfunded
Name [1] 303013 0
None
Address [1] 303013 0
None
Country [1] 303013 0
Primary sponsor type
Individual
Name
Dr Syed Tabish Razi Zaidi
Address
Adjucent Senior Lecturer,
Division of Pharmacy, College of Health and Medicine,
University of Tasmania,
Hobart, Tasmania,
Postal Address: Private Bag 26, Hobart, 7001.

Country
Australia
Secondary sponsor category [1] 302988 0
Individual
Name [1] 302988 0
Zahid Hussain
Address [1] 302988 0
Ph.D. Candidate,
Division of Pharmacy, College of Health and Medicine,
University of Tasmania,
Hobart, Tasmania.
Postal Address: Private Bag 26, Hobart, 7001.
Country [1] 302988 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303564 0
Human Research and Ethics Committee (Tasmania Network)
Ethics committee address [1] 303564 0
Human Research and Ethics Committee (Tasmania Network)
Office of Research Services,
University of Tasmania,
Private Bag 1
Hobart Tasmania 7001.
Ethics committee country [1] 303564 0
Australia
Date submitted for ethics approval [1] 303564 0
01/06/2016
Approval date [1] 303564 0
31/08/2016
Ethics approval number [1] 303564 0
H0015795

Summary
Brief summary
The hypothesis (based of the previous literature) of the study that obese patients should receive higher prophylactic anticoagulant doses.

Therfore, the purpose of the study was to evaluate drug dosing practice of prophylactic anticoagulants in obese patients who underwent gastric band surgery and to look at the clinical outcomes (venous thromboembolism and major bleed).




.
Trial website
Trial related presentations / publications
Public notes
We were not able to get the required number of patients in the given years, therefore we requested an amendment to ethics committee that we wanted to include the patients from year 2013-2017 in our retrospective audit to meet the required. The request for amendment was made on 24 April 2018 and was approved on 21 May 2018.

Contacts
Principal investigator
Name 94102 0
Mr Zahid Hussain
Address 94102 0
Division of Pharmacy, College of Health and Medicine, University of Tasmania
Private Bag 26, HOBART, TAS 7001
Location: Dobson Road, Sandy Bay (Building 18).
Country 94102 0
Australia
Phone 94102 0
+61 0362268535
Fax 94102 0
Email 94102 0
Zahid.Hussain@utas.edu.au
Contact person for public queries
Name 94103 0
Mr Zahid Hussain
Address 94103 0
Division of Pharmacy, College of Health and Medicine, University of Tasmania
Private Bag 26, HOBART, TAS 7001
Location: Dobson Road, Sandy Bay (Building 18).
Country 94103 0
Australia
Phone 94103 0
+61 0362268535
Fax 94103 0
Email 94103 0
Zahid.Hussain@utas.edu.au
Contact person for scientific queries
Name 94104 0
Mr Zahid Hussain
Address 94104 0
Division of Pharmacy, College of Health and Medicine, University of Tasmania
Private Bag 26, HOBART, TAS 7001
Location: Dobson Road, Sandy Bay (Building 18).
Country 94104 0
Australia
Phone 94104 0
+61 0362268535
Fax 94104 0
Email 94104 0
Zahid.Hussain@utas.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to sensitive nature of the study, we collected de-identified data from patients’ electronic medical profiles. Therefore, data cannot be shared with public or with any organization.
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 2311 0
Ethical approval
Citation [1] 2311 0
Link [1] 2311 0
Email [1] 2311 0
Other [1] 2311 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
There is a lack of clear guidance for the prophylactic use of anticoagulants for patients undergoing laparoscopic adjustable gastric banding (LAGB) surgery. This study aimed to evaluate the risk of venous thromboembolism (VTE), prophylactic use of enoxaparin and clinical outcomes in patients undergoing primary and revisional LAGB procedures.

A retrospective cohort study evaluated the prophylactic use of enoxaparin in adult patients who underwent primary and revisional (band and port) LAGB procedures. The incidence of VTE and major bleeding was investigated during a 90-day follow-up period.

We included 112 and 100 patients who had undergone primary and revisional LAGB surgery, respectively. The majority of patients (97%) had a mild risk of VTE development using a post-discharge VTE risk calculator tool published from the Cleveland Clinic. Overall, 69% patients received standard enoxaparin dose i.e 40 mg once daily. All primary procedure patients received prophylactic enoxaparin, compared to 79% and 20% of revisional patients who underwent band and port procedures, respectively. Use of enoxaparin was more common in patients admitted overnight. The overall VTE incidence after 90 days was 0.9%, and no major bleeding events were observed.


Obese patients received standard 40 mg daily dose of enoxaparin. No higher doses was given to obese patients, likely because LAGB is low risk surgical procedure.