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Trial registered on ANZCTR
Registration number
ACTRN12624000796583p
Ethics application status
Submitted, not yet approved
Date submitted
3/06/2024
Date registered
27/06/2024
Date last updated
27/06/2024
Date data sharing statement initially provided
27/06/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Residual heparinisation after cardiac surgery: A prospective observational study
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Scientific title
Residual heparinisation in adult patients after cardiac surgery: A prospective observational study
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Secondary ID [1]
312272
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ischaemic heart disease
333991
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Cardiac surgery
333992
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Condition category
Condition code
Anaesthesiology
330659
330659
0
0
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Anaesthetics
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Blood
330660
330660
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0
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Clotting disorders
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Cardiovascular
330661
330661
0
0
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Coronary heart disease
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Surgery
330792
330792
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0
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Other surgery
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Observational study of adult patients undergoing cardiac surgery. A single blood sample will be drawn from existing arterial cannulae and thromboelastography will be performed at 2-hours following return to ICU to assess for a residual heparin effect. The primary outcome will be to assess for a difference in bleeding, defined by drain tube outputs up to 24 hours post-operatively, identified between patients who do and do not have a residual heparin effect detected. Observational data will be collected from arrival in ICU until ICU discharge and will follow routine monitoring of post-cardiac surgical patients. There will be no further participant follow-up.
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Intervention code [1]
328732
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Diagnosis / Prognosis
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Comparator / control treatment
Patients without a significant difference between the Citrated Kaolin R-time (CK-R) and Citrated Kaolin-Heparinase R-time (CKH-R) on thromboelastography (no residual heparin effect).
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Control group
Active
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Outcomes
Primary outcome [1]
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Bleeding
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Assessment method [1]
338408
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Cardiac drain tube output will be recorded by ICU nursing staff according to a graduated drainage container. Drain tube outputs will be recorded half-hourly for the first 2 hours and hourly for the remainder of the ICU admission.
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Timepoint [1]
338408
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6, 12 and 24 hours following arrival in ICU post-operatively
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Primary outcome [2]
338409
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Proportion of patients with residual heparin effect
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Assessment method [2]
338409
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Difference between CK-R time and CKH-R time on thromboelastography performed on a blood sample drawn from an existing arterial cannula
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Timepoint [2]
338409
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2 hours following return to ICU
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Secondary outcome [1]
435811
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Number of packed red blood cells administered
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Assessment method [1]
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Transfusion of packed red blood cells, recorded on specific transfusion documentation in the medical record
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Timepoint [1]
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24 hours following arrival in ICU
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Secondary outcome [2]
435812
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Return to theatre for Haemostasis
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Assessment method [2]
435812
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Review of medical records to determine if return to theatre was undertaken in order to achieve Haemostasis following concerns for excessive bleeding
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Timepoint [2]
435812
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Duration of hospital admission
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Secondary outcome [3]
436431
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Number of units of Fresh Frozen Plasma (FFP) transfused
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Assessment method [3]
436431
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Transfusion of FFP, recorded on specific transfusion documentation in the medical record
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Timepoint [3]
436431
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24-hours following arrival in ICU
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Secondary outcome [4]
436432
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Number of units of platelets transfused
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Assessment method [4]
436432
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Transfusion of platelets, recorded on specific transfusion documentation in the medical record
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Timepoint [4]
436432
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24-hours following arrival in ICU
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Secondary outcome [5]
436433
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Number of units of cryoprecipitate transfused
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Assessment method [5]
436433
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Transfusion of cryoprecipitate, recorded on specific transfusion documentation in the medical record
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Timepoint [5]
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24-hours following arrival in ICU
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Secondary outcome [6]
436434
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Additional protamine administration for residual heparin effect
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Assessment method [6]
436434
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Review of medical records for protamine administration after arrival in ICU post-operatively
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Timepoint [6]
436434
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24-hours following arrival in ICU
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Eligibility
Key inclusion criteria
Adult patients undergoing any elective or emergency cardiac surgery
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
All cardiac surgical patients eligible
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Prospective
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Statistical methods / analysis
The target sample size of 100-patients was selected based on an average number of cases over a 3-month period, with additional additional time allowed for missed cases. As a hypothesis-generating study, a power calculation was not performed or required.
Data will be extracted from routinely collected patient data, accessed via scanned medical records and the Intellispace Critical Care and Anaesthesia (ICCA; Phillips, Netherlands) patient data management system. Participant data will be de-identified recorded on a secure, password protected document. Additional data relating to our primary outcome of interest will be stored in TEG manager® (Haemonetics, Switzerland).
Descriptive statistics will be used for our primary outcome of interest. Subgroup analysis will focus on differences in care received between patients who did or did not demonstrate a residual heparin effect in ICU. Subgroup differences will be reported as a mean difference, with differences between groups described using a Mann-U-Whitney test for outcomes with non-normal distributions, where a p<0.05 represents statistical significance.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/08/2024
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Actual
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Date of last participant enrolment
Anticipated
31/12/2024
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Actual
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Date of last data collection
Anticipated
28/02/2025
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
26640
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment postcode(s) [1]
42680
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3065 - Fitzroy
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Funding & Sponsors
Funding source category [1]
316659
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Self funded/Unfunded
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Name [1]
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Address [1]
316659
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Country [1]
316659
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Primary sponsor type
Individual
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Name
Liam O'Bryan - St Vincent's Hospital Melbourne
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Address
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Country
Australia
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Secondary sponsor category [1]
318844
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None
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Name [1]
318844
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Address [1]
318844
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Country [1]
318844
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315439
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St Vincent's Hospital Melbourne Human Research Ethics Committee
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Ethics committee address [1]
315439
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https://svhm.org.au/home/research/researchers/human-research-ethics-committee
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Ethics committee country [1]
315439
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Australia
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Date submitted for ethics approval [1]
315439
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03/06/2024
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Approval date [1]
315439
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Ethics approval number [1]
315439
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Summary
Brief summary
This observational study aims to assess whether a residual heparin effect is contributing to post-operative bleeding in cardiac surgical patients at a single institution. It will also assess whether testing for a residual heparin effect will help in reduce the transfusion of blood components perioperatively. The hypothesis being tested is that a proportion of patients undergoing cardiac surgery are returning to ICU with heparin activity affecting their normal coagulation and that this might result in inappropriate administration of platelets and other blood components.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Liam O'Bryan
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Address
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St Vincent's Hospital Melbourne, 41 Victoria Pde, Fitzroy, Victoria 3065
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Country
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Australia
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Phone
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+61 03 92312211
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Fax
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Email
134698
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[email protected]
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Contact person for public queries
Name
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Liam O'Bryan
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Address
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St Vincent's Hospital Melbourne, 41 Victoria Pde, Fitzroy, Victoria 3065
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Country
134699
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Australia
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Phone
134699
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+61 03 92312211
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Fax
134699
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Email
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[email protected]
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Contact person for scientific queries
Name
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Liam O'Bryan
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Address
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St Vincent's Hospital Melbourne, 41 Victoria Pde, Fitzroy, Victoria 3065
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Country
134700
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Australia
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Phone
134700
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+61 03 92312211
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Fax
134700
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Email
134700
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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