Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000763246
Ethics application status
Approved
Date submitted
18/08/2009
Date registered
2/09/2009
Date last updated
5/06/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Protecting the lungs in patients undergoing lung transplantation.
Scientific title
Does remote ischaemic post-conditioning reduce ischaemia reperfusion injury in patients undergoing lung transplantation?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemia-reperfusion injury in lung transplantation. 243535 0
Condition category
Condition code
Anaesthesiology 239835 239835 0 0
Other anaesthesiology
Surgery 239918 239918 0 0
Surgical techniques
Respiratory 239919 239919 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Normal best standard practice with remote ischaemic post-conditioning using 3 cycles of transient leg ischaemia and reperfusion (5 min ischaemia followed by 5 min reperfusion, 3 times) using a thigh tourniquet at least 5 min prior to donor lung reperfusion. Total stimulus 30 minutes prior to reperfusion.
Intervention code [1] 241144 0
Treatment: Other
Intervention code [2] 241209 0
Treatment: Surgery
Comparator / control treatment
Normal best standard practice.
Control group
Active

Outcomes
Primary outcome [1] 240600 0
PaO2/FiO2 ratios as measured by arterial blood gas sampling (arterial blood analysis). Where PaO2 represents partial pressure of oxygen in arterial blood and FiO2 represents fractional of inspired oxygen.
Timepoint [1] 240600 0
Time 0, 6, 12, 24, 48, 72 hours.
Secondary outcome [1] 257228 0
Right ventricular myocardial performance index (transoesophageal echocardiography parameter)
Timepoint [1] 257228 0
After chest closure
Secondary outcome [2] 257229 0
Incidence of ECMO (extracorporeal membrane oxygenation) requirement. ie ECMO support for oxygenation or not.
Timepoint [2] 257229 0
During first 72 hours post-operative.
Secondary outcome [3] 257230 0
Time to tracheal extubation.
Timepoint [3] 257230 0
During hospital stay.
Secondary outcome [4] 257231 0
Intensive care unit length of stay.
Timepoint [4] 257231 0
During hospital stay.
Secondary outcome [5] 257232 0
Hospital length of stay.
Timepoint [5] 257232 0
During hospital stay.

Eligibility
Key inclusion criteria
All patients listed for lung transplantation (single or double) by the Alfred Hospital lung transplant service.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients treated with sulphonylureas (oral hypoglycaemic agent).
Planned use cardiopulmonary bypass.
Planned combined heart-lung transplantation.

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)
Participants will be approached in an outpatient setting and written informed consent will be obtained. Eligible patients undergoing lung transplantation will be randomised using a computer-generated list and sealed opaque envelopes. Surgical and nursing staff will be blinded to the treatment groups as tourniquets will be applied to all patients but not inflated in controls.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will occur using a computer-generated list and sealed opaque envelopes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2009
Actual
28/12/2009
Date of last participant enrolment
Anticipated
Actual
27/09/2013
Date of last data collection
Anticipated
Actual
11/07/2014
Sample size
Target
60
Accrual to date
Final
60
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237513 0
Charities/Societies/Foundations
Name [1] 237513 0
Australia New Zealnad College of Anaesthetists
Country [1] 237513 0
Australia
Primary sponsor type
Individual
Name
Dr. Enjarn Lin
Address
The Alfred Hospital
Department of anaesthesia and perioperative medicine
55 Commercial Road
Melbourne
Victoria
3004
Country
Australia
Secondary sponsor category [1] 236992 0
Hospital
Name [1] 236992 0
The Alfred Hospital Department of anaesthesia and perioperative medicine
Address [1] 236992 0
The Alfred Hospital
Department of anaesthesia and perioperative medicine
55 Commercial Road
Melbourne
Victoria
3004
Country [1] 236992 0
Australia
Other collaborator category [1] 823 0
Individual
Name [1] 823 0
Prof. Paul Myles
Address [1] 823 0
The Alfred Hospital
Department of anaesthesia and perioperative medicine
55 Commercial Road
Melbourne
Victoria
3004
Country [1] 823 0
Australia
Other collaborator category [2] 824 0
Individual
Name [2] 824 0
Dr. Silvana Marasco
Address [2] 824 0
The Alfred Hospital
Department of cardiothoracic surgery
55 Commercial Road
Melbourne
Victoria
3004
Country [2] 824 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 243644 0
Alfred Research & Ethics Unit
Ethics committee address [1] 243644 0
55 Commercial Road
PO Box 315 Prahran
Victoria 3181 Australia
Ethics committee country [1] 243644 0
Australia
Date submitted for ethics approval [1] 243644 0
27/08/2009
Approval date [1] 243644 0
22/12/2009
Ethics approval number [1] 243644 0
1/09/0257

Summary
Brief summary
Randomised controlled trial to test if short periods of lack of blood flow to the leg can improve the function of new lungs in lung transplantation.
Trial website
Trial related presentations / publications
Lin, E et al. "Safety, feasibility, and effect of remote ischemic conditioning in patients undergoing lung transplantation" J Heart Lung Transplant. 2014 Nov;33(11):1139-48
Public notes

Contacts
Principal investigator
Name 30064 0
Address 30064 0
Country 30064 0
Phone 30064 0
Fax 30064 0
Email 30064 0
Contact person for public queries
Name 13311 0
Dr. Enjarn Lin
Address 13311 0
The Alfred Hospital
Department of anaesthesia and perioperative medicine
55 Commercial Road
Melbourne
Victoria
3004
Country 13311 0
Australia
Phone 13311 0
+613 90763176
Fax 13311 0
Email 13311 0
[email protected]
Contact person for scientific queries
Name 4239 0
Dr. Enjarn Lin
Address 4239 0
The Alfred Hospital
Department of anaesthesia and perioperative medicine
55 Commercial Road
Melbourne
Victoria
3004
Country 4239 0
Australia
Phone 4239 0
+613 90763176
Fax 4239 0
Email 4239 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
SourceTitleYear of PublicationDOI
Dimensions AISubstantial Increases Occur in Serum Activins and Follistatin during Lung Transplantation2016https://doi.org/10.1371/journal.pone.0140948
N.B. These documents automatically identified may not have been verified by the study sponsor.