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Trial registered on ANZCTR


Registration number
ACTRN12624001225505
Ethics application status
Approved
Date submitted
25/07/2024
Date registered
9/10/2024
Date last updated
9/10/2024
Date data sharing statement initially provided
9/10/2024
Date results information initially provided
9/10/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Protecting heart in heart operations: Evaluating the Terminal 'Hot Shot'
Scientific title
The effect of a Terminal 'Hot Shot' cardioplegia on Troponin I levels and myocardial recovery in adult coronary artery bypass grafting surgery
Secondary ID [1] 312597 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Bypass Graft 334524 0
Condition category
Condition code
Cardiovascular 331139 331139 0 0
Coronary heart disease
Surgery 331140 331140 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The effect of an enhanced mixture of blood with cell membrane stabilizing agents called as Terminal 'Hot Shot' cardioplegia(THS) is studied. THS consists of
20% Mannitol 20 ml
2% Xylocaine 60mg
15% Magnesium Sulphate 500mg
8.4% Sodium Bicarbonate 20ml
Hot water 50ml
Patients own warm Blood at 37 degree celsius 400ml

500ml of THS at 37°C, is administered both in the saphenous vein grafts at 100ml/each and the rest is delivered in the aortic root via intraortic infusion, at the termination of coronary artery bypass grafting while the patient is on Cardiopulmonary Bypass machine. The whole process of administration took 5-6 minutes by the lead cardiac surgeon.
Adherence to intervention was documented in operative report.
Cold blood cardioplegia was administered after placing the patient on Cardiopulmonary Bypass machine to arrest the heart in all patients. After arresting the heart, aorta was cross clamped and grafting started. In approximately 60mins of arrest (stated by the mean Aortic cross clamp time) THS administration was started.
THS administration was done in the intervention group after the aortic cross clamp was removed after all the distal anastomosis was performed, prior to doing proximal anastomosis , while the patient was on CPB.
Intervention code [1] 329123 0
Diagnosis / Prognosis
Intervention code [2] 329124 0
Treatment: Drugs
Comparator / control treatment
Composition of cold blood cardioplegia includes patients own blood with the following composition.
potassium, 21.5 mmol/L; magnesium, 18.2 mmol/L; calcium, 2.2 mmol/L; sodium, 145.1 mmol/L; procaine hydrochloride, 1.1 mmol/L; acetate, 6.5 mmol/L; chloride, 154.9 mmol/L; and hydrogen carbonate, 28.9 mmol/L (pH 7.4; temperature, 4°C – 8°C).
It was administered in the aortic root by the cardiac surgeon to arrest heart.
It was administered to the intervention group as well for the same purpose.
Operative report documented it's administration.
Control group
Active

Outcomes
Primary outcome [1] 338912 0
Troponin I levels
Timepoint [1] 338912 0
Blood sample collected after the patients heart achieved sinus rhythm.
Secondary outcome [1] 437890 0
Troponin I levels
Timepoint [1] 437890 0
Fifth postoperative day
Secondary outcome [2] 437891 0
Creatinine Kinase MB
Timepoint [2] 437891 0
Blood sample collected after the patient heart achieved sinus rhythm and at fifth postoperative day
Secondary outcome [3] 437892 0
Time to regain sinus rhythm after removing cross clamp on aorta
Timepoint [3] 437892 0
Since the aortic cross clamp is lifted to the time heart regained sinus rhythm
Secondary outcome [4] 437893 0
Cardiopulmonary Bypass (CPB) time
Timepoint [4] 437893 0
Since the patient is placed on CPB till the time he is removed from CPB
Secondary outcome [5] 437894 0
Aortic cross clamp time
Timepoint [5] 437894 0
Since the time Aorta is cross clamped to the time cross clamp is removed

Eligibility
Key inclusion criteria
Age >18 years (18years and older)
Coronary Artery Bypass Graft (CABG) patients
Body Mass Index (BMI) 18.5-29.9
Single or multivessel Coronary artery disease
New York Heart Association (NYHA) II-III
Canadian Classification system (CCS) II-III
Moderate Left anterior descending artery (LAD)occlusion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Redosurgery
Pre-op deranged blood reports
Pre-op pharmacological inotropes or mechanical Intra-Aortic balloon pump (IABP) requirement
Pre-op arrhythmias
Left Ventricular Ejection Fraction< 40%
Total proximal LAD occlusion
Left main stem stenosis

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
In a previous study by Karaaslan et. al (Karaarslan K, Abud B. Effects of Del Nido and Terminal Warm Blood Cardioplegia on Myocardial Protection and Rhythm in Isolated CABG Patients. The heart surgery forum. 2021;24(5):E808-e13.
The data was collected for sample size calculation or Troponin levels using WHO sample size calculator index 7.4b . SPSS version 25 was used to analyze the results. Chi square test was applied to all qualitative variables and Independent Samples t-test for all quantitative variables

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/12/2023
Date of last participant enrolment
Anticipated
Actual
5/02/2024
Date of last data collection
Anticipated
Actual
10/02/2024
Sample size
Target
60
Accrual to date
Final
60
Recruitment outside Australia
Country [1] 26455 0
Pakistan
State/province [1] 26455 0
Punjab (Faisalabad city)

Funding & Sponsors
Funding source category [1] 317024 0
Hospital
Name [1] 317024 0
Faisalabad Institute of Cardiology
Country [1] 317024 0
Pakistan
Primary sponsor type
Hospital
Name
Faisalabad Institute of Cardiology
Address
Country
Pakistan
Secondary sponsor category [1] 319271 0
Individual
Name [1] 319271 0
Muhammad Fahad Ghaffar (Self)
Address [1] 319271 0
Country [1] 319271 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315781 0
Faisalabad Institute of Cardiology Ethical Review Committee
Ethics committee address [1] 315781 0
Faisalabad Institute of Cardiology Civil lines Serena Road Faisalabad PO box# 38000
Ethics committee country [1] 315781 0
Pakistan
Date submitted for ethics approval [1] 315781 0
19/12/2023
Approval date [1] 315781 0
20/12/2023
Ethics approval number [1] 315781 0
46-2023DME/FIC/FSD

Summary
Brief summary
In a randomized controlled trial two groups (control and sample) subjected to ischemic insults while having surgery of heart were evaluated for their extent of heart musculature recovery. Sample group received a blood enhanced mixture of cell membrane stabilizing agents and showed an enhanced improvement of heart function depicted by a decrease in Troponin I release from heart cells.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135770 0
Dr Muhammad Fahad Ghaffar
Address 135770 0
Faisalabad Institute of Cardiology Civil lines Serena road Faisalabad PO box # 38000
Country 135770 0
Pakistan
Phone 135770 0
+923214314624
Fax 135770 0
Email 135770 0
[email protected]
Contact person for public queries
Name 135771 0
Muhammad Fahad Ghaffar
Address 135771 0
Faisalabad Institute of Cardiology Civil lines Serena road Faisalabad PO box # 38000
Country 135771 0
Pakistan
Phone 135771 0
+923214314624
Fax 135771 0
Email 135771 0
[email protected]
Contact person for scientific queries
Name 135772 0
Muhammad Fahad Ghaffar
Address 135772 0
Faisalabad Institute of Cardiology Civil lines Serena road Faisalabad PO box # 38000
Country 135772 0
Pakistan
Phone 135772 0
+923214314624
Fax 135772 0
Email 135772 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24041Ethical approval    388178-(Uploaded-25-07-2024-18-24-36)-IRB TSH.pdf



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.