Trial Review

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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
Scientific title
Residual heparinisation in adult patients after cardiac surgery: A prospective observational study
Secondary ID [1] 312272 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischaemic heart disease 333991 0
Cardiac surgery 333992 0
Condition category
Condition code
Anaesthesiology 330659 330659 0 0
Anaesthetics
Blood 330660 330660 0 0
Clotting disorders
Cardiovascular 330661 330661 0 0
Coronary heart disease
Surgery 330792 330792 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 328732 0
Diagnosis / Prognosis
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).
Control group
Active

Outcomes
Primary outcome [1] 338408 0
Bleeding
Timepoint [1] 338408 0
6, 12 and 24 hours following arrival in ICU post-operatively
Primary outcome [2] 338409 0
Proportion of patients with residual heparin effect
Timepoint [2] 338409 0
2 hours following return to ICU
Secondary outcome [1] 435811 0
Number of packed red blood cells administered
Timepoint [1] 435811 0
24 hours following arrival in ICU
Secondary outcome [2] 435812 0
Return to theatre for Haemostasis
Timepoint [2] 435812 0
Duration of hospital admission
Secondary outcome [3] 436431 0
Number of units of Fresh Frozen Plasma (FFP) transfused
Timepoint [3] 436431 0
24-hours following arrival in ICU
Secondary outcome [4] 436432 0
Number of units of platelets transfused
Timepoint [4] 436432 0
24-hours following arrival in ICU
Secondary outcome [5] 436433 0
Number of units of cryoprecipitate transfused
Timepoint [5] 436433 0
24-hours following arrival in ICU
Secondary outcome [6] 436434 0
Additional protamine administration for residual heparin effect
Timepoint [6] 436434 0
24-hours following arrival in ICU

Eligibility
Key inclusion criteria
Adult patients undergoing any elective or emergency cardiac surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All cardiac surgical patients eligible

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2024
Actual
Date of last data collection
Anticipated
28/02/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26640 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 42680 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 316659 0
Self funded/Unfunded
Name [1] 316659 0
Country [1] 316659 0
Primary sponsor type
Individual
Name
Liam O'Bryan - St Vincent's Hospital Melbourne
Address
Country
Australia
Secondary sponsor category [1] 318844 0
None
Name [1] 318844 0
Address [1] 318844 0
Country [1] 318844 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315439 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 315439 0
https://svhm.org.au/home/research/researchers/human-research-ethics-committee
Ethics committee country [1] 315439 0
Australia
Date submitted for ethics approval [1] 315439 0
03/06/2024
Approval date [1] 315439 0
Ethics approval number [1] 315439 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134698 0
Dr Liam O'Bryan
Address 134698 0
St Vincent's Hospital Melbourne, 41 Victoria Pde, Fitzroy, Victoria 3065
Country 134698 0
Australia
Phone 134698 0
+61 03 92312211
Fax 134698 0
Email 134698 0
liam.obryan@svha.org.au
Contact person for public queries
Name 134699 0
Liam O'Bryan
Address 134699 0
St Vincent's Hospital Melbourne, 41 Victoria Pde, Fitzroy, Victoria 3065
Country 134699 0
Australia
Phone 134699 0
+61 03 92312211
Fax 134699 0
Email 134699 0
liam.obryan@svha.org.au
Contact person for scientific queries
Name 134700 0
Liam O'Bryan
Address 134700 0
St Vincent's Hospital Melbourne, 41 Victoria Pde, Fitzroy, Victoria 3065
Country 134700 0
Australia
Phone 134700 0
+61 03 92312211
Fax 134700 0
Email 134700 0
liam.obryan@svha.org.au

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?

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.