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Trial registered on ANZCTR


Registration number
ACTRN12613001324707
Ethics application status
Not yet submitted
Date submitted
26/11/2013
Date registered
2/12/2013
Date last updated
2/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Low-dose heparin in critically ill patients undergoing extracorporeal membrane oxygenation – Feasibility study
Scientific title
Feasibility of administrating a low dose anti coagulant in critically ill patients undergoing Extracorporeal Membrane Oxygenation: a pilot study
Secondary ID [1] 283654 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
critically ill patients undergoing extracorporeal membrane oxygenation 290605 0
Condition category
Condition code
Blood 290995 290995 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Critically ill patients undergoing extracorporeal membrane oxygenation in this group will receive heparin infusion, based on weight (if body weight <50 kg: 8 000 units/24 hours; if body weight comprised between 50 and 70 kg: heparin 10 000 units /24 hours; if body weight >70 kg: 12 000 units/ 24 hours) in absence of any indication for full systemic anticoagulation, and in absence of bleeding. If the Activated Partial Thromboplastin Time (APTT) is higher than 45, the heparin will be withhold until the APTT is equal or less than 45seconds. The APTT is monitored 6 hourly. The intervention will last until the ECMO is removed
Intervention code [1] 288356 0
Prevention
Comparator / control treatment
Critically ill patients undergoing extra corporeal membrane oxygenation usually receive full systemic anti coagulation with infusion of heparin over 24 hours, unless the patient is bleeding. The dose of heparin is variable between patients and is based on an APTT comprised between 50 and 70 seconds. This treatment is given over the ECMO course.
This control group is standard practice where the study is going to be conducted.
Control group
Dose comparison

Outcomes
Primary outcome [1] 290975 0
Primary Endpoints for feasibility:
Difference in the mean daily dose of heparin between both study groups

Timepoint [1] 290975 0
At the end of extra corporeal membrane oxygenation course
Primary outcome [2] 290982 0
Primary Endpoints for safety:
Incidence of ECMO circuit thrombosis requiring circuit change
Incidence of new major systemic thromboembolic events defined as stroke, limb ischemia related to intravascular
Timepoint [2] 290982 0
At the end of extra corporeal membrane oxygenation course
Primary outcome [3] 290990 0
Difference in the mean APTT and the mean anti-Xa between both study groups thrombosis or emboli or intra-cardiac thrombus
Timepoint [3] 290990 0
at the end of the ECMO course
Secondary outcome [1] 305714 0
Number of RBC administered per ECMO day
Timepoint [1] 305714 0
At ECMO ceased, ICU discharge and hospital discharge
Secondary outcome [2] 305735 0
Number of days on the bleeding management protocol
Timepoint [2] 305735 0
end of ECMO course
Secondary outcome [3] 305736 0
Bleeding events defined by a bleeding associated with either a drop in haemoglobin concentration by 20 g/L or a transfusion of at least 2 units of packed red blood cells/24 hours
Timepoint [3] 305736 0
until the end of ECMO course
Secondary outcome [4] 305737 0
ICU and Hospital mortality
Timepoint [4] 305737 0
ICU and Hospital discharge
Secondary outcome [5] 305738 0
ICU and Hospital length of stay
Timepoint [5] 305738 0
ICU and hospital discharge
Secondary outcome [6] 305739 0
New pulmonary emboli and deep vein thrombosis
Timepoint [6] 305739 0
ICU discharge
Secondary outcome [7] 305740 0
Number of blood product transfused (Red Blood cells, fresh frozen plasma, Platelets) during the ICU stay and after randomisation
Timepoint [7] 305740 0
ICU discharge
Secondary outcome [8] 305741 0
Number of blood stream infection diagnosed post randomisation in ICU
Timepoint [8] 305741 0
ICU discharge

Eligibility
Key inclusion criteria
patients hospitalised in intensive care unit who require ECMO or on ECMO for less than 48 hours.
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age younger than 16 years
Pregnancy
Known objection to the administration of human blood products
Participation in a competing study on anticoagulation
Heparin-induced thrombocytopenia
Any pre-existing indication for prolonged full dose anti-coagulation: long-term warfarin for atrial fibrillation), pulmonary emboli, deep venous thrombosis, intra-cardiac thrombus

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
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)
VIC

Funding & Sponsors
Funding source category [1] 288332 0
Self funded/Unfunded
Name [1] 288332 0
Address [1] 288332 0
Country [1] 288332 0
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
Alfred Hospital
89 Commercial Road
3004 Melbourne
Victoria
Country
Australia
Secondary sponsor category [1] 287048 0
None
Name [1] 287048 0
Address [1] 287048 0
Country [1] 287048 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290225 0
Alfred Hospital Ethic Committee
Ethics committee address [1] 290225 0
Alfred Hospital
89 Commercial Road, Melbourne 3004
VIC
Ethics committee country [1] 290225 0
Australia
Date submitted for ethics approval [1] 290225 0
18/11/2013
Approval date [1] 290225 0
Ethics approval number [1] 290225 0

Summary
Brief summary
Extra corporeal membrane oxygenation (ECMO) in intensive care unit (ICU) is a rescue therapy for reversible cardiac and/or respiratory failures. It can also provide support until cardiac or lung transplantation. Haemorrhagic complications are the most frequent of the complications occurring on ECMO, and they have been shown to independently impact on patients’ prognosis. Although some of the haemorrhagic complications may be related to patient severity or patient disease, improving anticoagulation management may prevent some bleeding events and improve patient outcome.
The primary aim of this study is to determine the feasibility of administrating low dose anti coagulation in critically ill patients on ECMO when there is no indication for full systemic anticoagulation
We will randomise 20 patients so that 10 will receive low dose heparin and compare their complications and outcomes to the other 10 patients treated with the standard dose of heparin.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44570 0
Prof Jamie D Cooper
Address 44570 0
The Alfred Hospital
Intensive Care Unit
89 Commercial Road, Melbourne 3004
VIC
Country 44570 0
Australia
Phone 44570 0
+61 3 9903 0343
Fax 44570 0
Email 44570 0
jamie.cooper@monash.edu
Contact person for public queries
Name 44571 0
Dr Cecile Aubron
Address 44571 0
ANZIC-RC, DEPM, Monash University
The Alfred Centre
99 Commercial Road
3004 Melbourne
VIC
Country 44571 0
Australia
Phone 44571 0
+61399030068
Fax 44571 0
Email 44571 0
cecile.aubron@monash.edu
Contact person for scientific queries
Name 44572 0
Dr Cecile Aubron
Address 44572 0
ANZIC-RC, DEPM, Monash University
The Alfred Centre
99 Commercial Road
3004 Melbourne
VIC
Country 44572 0
Australia
Phone 44572 0
+61399030068
Fax 44572 0
Email 44572 0
cecile.aubron@monash.edu

No information has been provided regarding IPD availability
Summary results
No Results