Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000594123
Ethics application status
Approved
Date submitted
9/04/2019
Date registered
17/04/2019
Date last updated
17/04/2019
Date data sharing statement initially provided
17/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of exercise on coagulation in patients with continuous flow blood pumps
Scientific title
The effect of exercise on von Willebrand factor in patients with continuous flow left ventricular assist device
Secondary ID [1] 297926 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
von Willebrand syndrome 312398 0
Condition category
Condition code
Blood 310961 310961 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
To investigate the relationship between exercises and changes of von Willebrand factor profile in adult patients with left ventricular assist device. This is a prospective, single-centre observational pilot study. Exercise therapy is part of the standard care for all LVAD and heart transplant patients in the first period after their discharge from the hospital.

To be considered for the study, the patients need to be medically stable, and be able to tolerate minimum 30 minutes of exercise at moderate intensity. After consent is obtained – blood will be collected pre / post exercise once per week for 5 weeks. Blood samples will be taken over 5 weeks in order to correlate changes in coagulation blood profile pre and post exercise with increases in patient’s overall fitness post-LVAD implantation.

A 6-minute walk test will be performed before the exercise session to help calculate and set the suitable intensity of exercise. Blood will be sampled pre and post exercise at each time point. Patients will perform the exercise either in the gym as part of standard post VAD exercise therapy, or in the usual VAD exercise class if the patient is an outpatient. The exercise session will be standardised, and the patient will receive 30 minutes exercise (treadmill or cycling on a stationary ergometer), at a moderate intensity of 11-13 on the Borg scale (6-20 scale).
Intervention code [1] 314150 0
Not applicable
Comparator / control treatment
To investigate the relationship between exercises and changes of von Willebrand factor profile in heart transplant patients (previously requiring a ventricular assist device) and healthy volunteers. Both control groups undergo the same exercise protocol as those with left ventricular assist device.
Control group
Active

Outcomes
Primary outcome [1] 319703 0
The primary outcome is to evaluate the change of von Willebrand factor profile at pre and post exercise.

The blood samples collected at pre and post will be assessed by following methods (1) vWF multimers will be characterized with electrophoresis and immunoblot analysis (2) von Willebrand factor activity will be measured by Multiplate using ristocetin and collagen (3) the concentration of vWF will be measured by commercial ELISA kit.
Timepoint [1] 319703 0
Two citrated tubes (3.5 mL) of blood will be taken at pre- and immediately post-exercise via phlebotomy by a qualified phlebotomist and sent to the study research laboratory at that site for immediate processing (within 4 hr).

Each participant's blood will be taken at pre and post exercise for once a week over 5 weeks in order to correlate changes in vWF profile pre and post exercise with increases in patient’s overall fitness post-LVAD implantation.
Secondary outcome [1] 369471 0
The secondary outcome is to evaluate the change of platelet function profile at pre and post exercise.

The blood samples collected at pre and post will be assessed by platelet function will be measured by Multiplate using thrombin receptor activating peptide-6 (TRAP6) and adenosine diphosphate (ADP).
Timepoint [1] 369471 0
Two citrated tubes (3.5 mL) of blood will be taken at pre- and immediately post-exercise via phlebotomy by a qualified phlebotomist and sent to the study research laboratory at that site for immediate processing (within 4 hr).

Each participant's blood will be taken at pre and post exercise for once a week over 5 weeks in order to correlate changes in platelet profile pre and post exercise with increases in patient’s overall fitness post-LVAD implantation.

Eligibility
Key inclusion criteria
For LVAD patient group

• Adult patient >18 years who received a LVAD
• Consent obtained from patient
• The patients need to be medically stable, and be able to tolerate minimum 30 minutes of exercise at moderate intensity

For heart transplant patient group (Control Group A)

• Adult patient >18 years who underwent heart transplant (previously requiring a VAD)
• Consent obtained from patient
• The patients need to be medically stable, and be able to tolerate minimum 30 minutes of exercise at moderate intensity

For healthy volunteer group (Control Group B)

• Adult patient >18 years are healthy volunteers
• Consent obtained from healthy volunteers
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Haematological malignancy
• Pregnant
• Cardiovascular or orthopaedic conditions preventing exercise therapy (such as cardiovascular instability, bone fractures etc.)

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Sample Size: 15 for each group (LVAD patient group, heart transplant patient group, and healthy volunteer group)

Analysis
Descriptive statistics will report mean (standard deviation) as appropriate.

Haemolysis, von Willebrand factor multimer analysis, function and concentration, Angiopoietin-2 concentration, platelet activation and function, ADAMTS13 concentration, and Factor VIII (FVIIIc) activity at pre and post exercise will be compared using appropriate statistical tests, depending on data distribution.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2019
Actual
Date of last participant enrolment
Anticipated
30/06/2022
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
45
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13581 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 26240 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 302442 0
Charities/Societies/Foundations
Name [1] 302442 0
The Prince Charles Hospital Foundation
Country [1] 302442 0
Australia
Funding source category [2] 302447 0
Charities/Societies/Foundations
Name [2] 302447 0
Haemophilia Foundation Australia Research Fund
Country [2] 302447 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Critical Care Research Group
Clinical Sciences Building, Level 3
Rode Rd, Chermside, Queensland
4032
Country
Australia
Secondary sponsor category [1] 302344 0
None
Name [1] 302344 0
Address [1] 302344 0
Country [1] 302344 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303111 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 303111 0
Research Ethics and Governance Unit
Building 14
The Prince Charles Hospital
Rode Road, Chermside, Queensland
4032
Ethics committee country [1] 303111 0
Australia
Date submitted for ethics approval [1] 303111 0
11/03/2019
Approval date [1] 303111 0
19/03/2019
Ethics approval number [1] 303111 0
Project ID HREC/19/QPCH/50368

Summary
Brief summary
The goal of this pilot study is to evaluate whether exercise can reverse the acquired von Willebrand syndrome occurs in patients with continuous-flow left ventricular assist device (CF-LVAD).

We hypothesis that increasing pulsatility (vasoconstriction process) through performing active exercise might preserve vital coagulation protein (vWF) from excessive degradation and even restore normal vWF profile.

This is a prospective, single-centre observational pilot study designed to assess the effect of exercise on the recovery of a vital coagulation protein vWF in patients supported with CF-LVAD (n = 15) compare to heart transplant patients (previously requiring a CF-LVAD) (n=15) and healthy volunteers (n =15).

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92514 0
Dr Hoi Houng Chan
Address 92514 0
Critical Care Research Group
Clinical Sciences Building, Level 3
The Prince Charles Hospital
Rode Road, Chermside, Queensland
4032
Country 92514 0
Australia
Phone 92514 0
+61424887256
Fax 92514 0
Email 92514 0
[email protected]
Contact person for public queries
Name 92515 0
Dr Hoi Houng Chan
Address 92515 0
Critical Care Research Group
Clinical Sciences Building, Level 3
The Prince Charles Hospital
Rode Road, Chermside, Queensland
4032
Country 92515 0
Australia
Phone 92515 0
+61424887256
Fax 92515 0
Email 92515 0
[email protected]
Contact person for scientific queries
Name 92516 0
Dr Hoi Houng Chan
Address 92516 0
Critical Care Research Group
Clinical Sciences Building, Level 3
The Prince Charles Hospital
Rode Road, Chermside, Queensland
4032
Country 92516 0
Australia
Phone 92516 0
+61424887256
Fax 92516 0
Email 92516 0
[email protected]

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
1827Ethical approval    377364-(Uploaded-09-04-2019-15-29-33)-Study-related document.pdf



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.