Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001306303
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/01/2026
Date registered
Help: Date registered
29/10/2026
Date last updated
Help: Date last updated
29/10/2026
Date data sharing statement initially provided
Help: Data sharing statement date
29/10/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A study to assessing a device to measure the efficiency of extracorporeal life support machines
Scientific title
A prospective observational cohort study describing membrane oxygenator thrombus volume in patients receiving extracorporeal membrane oxygenator support using ultrasound dilution technology (Extracorporeal Life Support Assurance (ELSA) monitor)
Additional trial identifiers [1] 316368 0
None
Universal Trial Number (UTN)
Trial acronym
ULTRACLOT - Ultrasound Longitudinal Tracking of Recirculation And Clot Load in Oxygenator Thrombosis
Related trial records

Health condition
Health condition(s) studied:
Respiratory Requiring Extra Corporeal Support 340439 0
Cardiac Failure Requiring Extra Corporeal Support 343426 0
Condition category
Condition code
Respiratory 336654 336654 0 0
Other respiratory disorders / diseases
Cardiovascular 336989 336989 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of the intervention or exposure
This single-centre prospective observational study investigates extracorporeal membrane oxygenation (ECMO) circuit performance using ultrasound dilution technology.

ECMO is an advanced mechanical circulatory support modality that removes, oxygenates and pumps blood back to a critically ill patient. Sometime it provides respiratory failure support (Venovenous (VV) ECMO) or cardiac and respiratory support (Venoarterial (VA) ECMO).

The parent study ULTRACLOT - Oxygenator Blood Volume (OXBV) assesses membrane oxygenator clot burden in all adult ECMO patients. A predefined sub-study ULTRACLOT - 2 Tips (2TIPS) evaluates recirculation fraction exclusively in patients receiving VVECMO.

Both studies utilise the Transonic ELSA® monitor and do not alter standard clinical care; we are comparing the use of this monitor, to the performance of our standard markers of clot burden and recirculation.

Participants are having additional measurements taken of their ECMO circuits performance and the this additional data will be correlated with current data that is recorded in their medical record related to circuit performance, as well as major ECMO circuit events (such as membrane circuit changes, or urgent circuit failures)

Additional measurements are only taken whilst on ECMO - the total duration of observation is until hospital discharge.
Intervention code [1] 333029 0
Not applicable
Description of the comparator or control
Our comparator is to the usual markers of oxygenator clot and recirculation

Current practice is to undertake four main assessments:
- Daily membrane pressure drop (delta P) recorded by the ECMO machine and in the patients medical record
- Blood markers of haemolysis and fibrinolysis (D-dimer, plasma free haemoglobin, CO-Hb (carboxyhaemoglobin), fibrinogen, platelet count, LDH, bilirubin) run each day on all our ECMO patients and reported by our pathology lab
- Visual assessment of the membrane surface for clots recorded by the nursing staff as part of standard circuit observations
- SvO2 % (the saturation of blood in the venous line of the ECMO circuit) recorded in the patients medical record
Control group
Active

Outcomes
Primary outcome [1] 344171 0
For the oxygenator blood volume component of the study (All patients): Daily change in Membrane Resistance Index as compared to measured oxygenator blood volume as measured by ELSA, over the life of the first 7 days of use of each circuit
Timepoint [1] 344171 0
Daily consecutive measurements for 7 days
Primary outcome [2] 344172 0
To describe how recirculation fraction compares between different configurations of VV ECMO
Timepoint [2] 344172 0
Daily measurement for the duration of the ECMO run (until ECMO cessation)
Primary outcome [3] 346696 0
For the oxygenator blood volume component of the study (All patients): Daily Membrane Resistance Index and % change in oxygenator blood volume as measured by ELSA, over the life of the first 7 days of use of each circuit
Timepoint [3] 346696 0
Daily consecutive measurements for 7 days
Secondary outcome [1] 456925 0
Daily % change in OXBV using ELSA monitor and change in MRI around circuit change events
Timepoint [1] 456925 0
We will collect data on 3 days prior and 3 days after a circuit change event, analysis will focus on the day prior to a circuit change
Secondary outcome [2] 456926 0
‘Major Clot Burden Related Events’ and % change in OXBV measurement by ELSA monitor
Timepoint [2] 456926 0
Observation over the duration of ECMO run for predefined major events: i. Bleeding events (BARC >3) ii. Transfusion Burden iii. Stage III KDIGO Acute kidney Injury iv. Dialysis Requirement Single daily measurement taken on the days these events occurred and assessed as a composite outcome
Secondary outcome [3] 462447 0
Describe the incidence of Bleeding Events around the time of circuit changes
Timepoint [3] 462447 0
3 days prior and 3 days after a circuit change event
Secondary outcome [4] 462448 0
Changes in conventional markers of clot formation.
Timepoint [4] 462448 0
Daily measurements for duration of ECMO run (until ECMO cessation)
Secondary outcome [5] 462449 0
Anticoagulation intensity
Timepoint [5] 462449 0
Daily measurement for duration of ECMO run (until ECMO cessation)
Secondary outcome [6] 462450 0
ECMO blood flow
Timepoint [6] 462450 0
Daily measurements for first 7 days of ECMO run
Secondary outcome [7] 462452 0
Safety outcomes
Timepoint [7] 462452 0
Duration of Hospital Stay
Secondary outcome [8] 462453 0
For the VVECMO Rf Subgroups - cannula tip separation
Timepoint [8] 462453 0
Daily measurement of cannula position on CXR and daily measurement of Rf until ECMO cessation
Secondary outcome [9] 462454 0
Cannula size and position
Timepoint [9] 462454 0
Data on cannula configuration on ECMO Insertion
Secondary outcome [10] 462455 0
Exploratory outcomes: a. Venous access pressures,
Timepoint [10] 462455 0
Daily measurement of circuit parameters, and measurements of static parameters (cannula size) until ECMO cessation, And hospital length of stay (LOS) follow up for outcomes.
Secondary outcome [11] 467046 0
Exploratory outcomes: b. ECMO Oxygen delivery parameters
Timepoint [11] 467046 0
Daily measurement of circuit parameters, and measurements of static perameters (cannula size) until ECMO cessation, And hospital LOS follow up for outcomes.
Secondary outcome [12] 467047 0
Exploratory outcomes: c. ECMO duration
Timepoint [12] 467047 0
Daily measurement of circuit parameters, and measurements of static perameters (cannula size) until ECMO cessation, And hospital LOS follow up for outcomes.
Secondary outcome [13] 467048 0
Exploratory outcomes: d. Duration of mechanical ventilation
Timepoint [13] 467048 0
Daily measurement of circuit parameters, and measurements of static perameters (cannula size) until ECMO cessation, And hospital LOS follow up for outcomes.
Secondary outcome [14] 467049 0
Exploratory outcomes: e. ICU LOS
Timepoint [14] 467049 0
Daily measurement of circuit parameters, and measurements of static perameters (cannula size) until ECMO cessation, And hospital LOS follow up for outcomes.
Secondary outcome [15] 467050 0
Exploratory outcomes: f. Hospital LOS
Timepoint [15] 467050 0
Daily measurement of circuit parameters, and measurements of static perameters (cannula size) until ECMO cessation, And hospital LOS follow up for outcomes.
Secondary outcome [16] 467051 0
Exploratory outcomes: g. Survival to Decannulation
Timepoint [16] 467051 0
Daily measurement of circuit parameters, and measurements of static perameters (cannula size) until ECMO cessation, And hospital LOS follow up for outcomes.
Secondary outcome [17] 467052 0
Exploratory outcomes: h. Survival Discharge
Timepoint [17] 467052 0
Daily measurement of circuit parameters, and measurements of static perameters (cannula size) until ECMO cessation, And hospital LOS follow up for outcomes.
Secondary outcome [18] 467053 0
We will also descriptively assess variations in haemolysis in each tertile of OXBV OXBV measurements are via the ELSA monitor.
Timepoint [18] 467053 0
Day prior to circuit change
Secondary outcome [19] 467054 0
We will also descriptively assess variations in fibrinolysis in each tertile of OXBV. OXBV measurements are via the ELSA monitor.
Timepoint [19] 467054 0
Day prior to circuit change
Secondary outcome [20] 467055 0
We will also descriptively assess variations in ECMO duration in each tertile of OXBV. OXBV measurements are via the ELSA monitor. Other measurements are from the ECMO machine or daily blood tests.
Timepoint [20] 467055 0
Day prior to circuit change for OXBV, and Hospital LOS for ECMO duration
Secondary outcome [21] 467057 0
We will descriptively assess variations in number of circuit changes in each tertile of OXBV.. OXBV measurements are via the ELSA monitor.
Timepoint [21] 467057 0
Hospital LOS for circuit changes, and Day Prior to first circuit change for OXBV
Secondary outcome [22] 467058 0
Safety outcomes
Timepoint [22] 467058 0
Duration of ICU Stay
Secondary outcome [23] 467059 0
Safety outcomes
Timepoint [23] 467059 0
Duration of Hospital Stay
Secondary outcome [24] 467060 0
Safety outcomes
Timepoint [24] 467060 0
Time to decannulation
Secondary outcome [25] 467061 0
Safety outcomes
Timepoint [25] 467061 0
Time to Discharge
Secondary outcome [26] 467062 0
Safety outcomes
Timepoint [26] 467062 0
Duration of Hospital Stay
Secondary outcome [27] 467072 0
Describe the incidence of transfusion requirements around the time of circuit changes
Timepoint [27] 467072 0
3 days prior and 3 days after a circuit change event

Eligibility
Key inclusion criteria
INCLUSION CRITERIA
Aged >= 18 years
Cannulated to ECMO, or initiated elsewhere and retrieved to RPA
Survival >24 hours on ECMO support

ALL ECMO -> ULTRACLOT Group
VV ECMO Only -> 2TIPS Sub-Group
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
EXCLUSION CRITERIA
Duration of ECMO or survival from inclusion anticipated to be less than 24 hours, or death before inclusion.
Renal replacement therapy being administered via the pigtail connections of the ECMO circuit at the time of an intended OXBV assessment: in this case, patients may still be able to contribute data when not connected to the dialysis machine.

Study design
Purpose
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/11/2026
Actual
Date of last participant enrolment
Anticipated
13/11/2028
Actual
Date of last data collection
Anticipated
30/11/2028
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29077 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 45367 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 320976 0
Government body
Name [1] 320976 0
Sydney Local Health District
Country [1] 320976 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 323673 0
None
Name [1] 323673 0
Address [1] 323673 0
Country [1] 323673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319509 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 319509 0
Ethics committee country [1] 319509 0
Australia
Date submitted for ethics approval [1] 319509 0
26/01/2026
Approval date [1] 319509 0
08/05/2026
Ethics approval number [1] 319509 0
2026/ETH00082

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 147558 0
Dr Elliott Worku
Address 147558 0
Intensive Care Service, Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown NSW 2050
Country 147558 0
Australia
Phone 147558 0
+61474132826
Fax 147558 0
Email 147558 0
[email protected]
Contact person for public queries
Name 147559 0
Elliott Worku
Address 147559 0
Intensive Care Service, Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown NSW 2050
Country 147559 0
Australia
Phone 147559 0
+61 295156000
Fax 147559 0
Email 147559 0
[email protected]
Contact person for scientific queries
Name 147560 0
Elliott Worku
Address 147560 0
Intensive Care Service, Royal Prince Alfred Hospital, 50 Missenden Rd, Camperdown NSW 2050
Country 147560 0
Australia
Phone 147560 0
+61 295156000
Fax 147560 0
Email 147560 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires approval by an ethics committee
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: Please contact the Primary Investigator at [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.