Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001048875
Ethics application status
Approved
Date submitted
25/05/2021
Date registered
10/08/2021
Date last updated
10/08/2021
Date data sharing statement initially provided
10/08/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does fibrinolytic capacity influence stroke outcomes?
Scientific title
Does fibrinolytic capacity influence stroke outcomes in patients who were thrombolysed after an acute ischemic stroke?
Secondary ID [1] 304318 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ischemic stroke 322067 0
Condition category
Condition code
Stroke 319786 319786 0 0
Ischaemic

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Four set of blood samples from patients who presented with ischemic stroke and was thrombolysed will be collected on arrival and 1, 24 and 72 hours post thrombolysis. Four set of blood samples from patients who presented with ischemic stroke but was not thrombolysed will also be collected on arrival and 1, 24 and 72 hours post arrival. No further information will be collected and no follow up is required. The study will recruit patients for up to 2 years with no specified upper limit for total number of patients.
Intervention code [1] 321095 0
Diagnosis / Prognosis
Comparator / control treatment
Blood samples from patients who presented with ischemic stroke and was not thrombolysed
Control group
Active

Outcomes
Primary outcome [1] 327647 0
Exploratory assessment of biochemical markers of fibrinolysis activity from the plasma samples
Timepoint [1] 327647 0
At bloods pre thrombolysis, and at 1, 24 and 72 hours post thrombolysis from the plasma samples
Primary outcome [2] 328190 0
Exploratory assessment of immune suppression markers from the plasma samples
Timepoint [2] 328190 0
At bloods pre thrombolysis, and at 1, 24 and 72 hours post thrombolysis
Secondary outcome [1] 396073 0
Nil
Timepoint [1] 396073 0
Nil

Eligibility
Key inclusion criteria
Adult patients presented to the health service with clinical signs / radiological findings consistent with acute ischemic stroke
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients presenting with acute haemorrhagic stroke or unsurvivable stroke

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
29/06/2021
Date of last participant enrolment
Anticipated
31/05/2023
Actual
Date of last data collection
Anticipated
31/05/2023
Actual
Sample size
Target
40
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19554 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 34163 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 308691 0
Government body
Name [1] 308691 0
NHMRC
Country [1] 308691 0
Australia
Primary sponsor type
University
Name
Monash university
Address
Monash University, Wellington Road, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 309574 0
Hospital
Name [1] 309574 0
Alfred Health
Address [1] 309574 0
Alfred Health, 55 commercial road, Melbourne, VIC 3004
Country [1] 309574 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308614 0
The Alfred Ethics committee
Ethics committee address [1] 308614 0
Alfred Hospital, 55 commercial road, Melbourne, VIC 3004
Ethics committee country [1] 308614 0
Australia
Date submitted for ethics approval [1] 308614 0
18/03/2021
Approval date [1] 308614 0
18/05/2021
Ethics approval number [1] 308614 0
188/21

Summary
Brief summary
Stroke is commonly caused by blockage of arteries which carry blood and oxygen to the brain. Thrombolysis, a process of unblocking or recanalizing blood vessels with an injection of tissue plasminogen activator (tPA), has become a standard of care in acute stroke treatment however, only ~40% patients will respond to treatment. This study looks at the variation in blood protein biomarkers involved in thrombolysis including plasmin levels and its relation to the recanalization effect.

Adult patients arriving at The Alfred with acute ischemic stroke will be recruited for the study. Informed consent will be obtained from the patient or from the patient’s Medical Treatment Decision Maker (MTDM). Consent will be gained for gaining research blood samples and to use clinical information contained in the hospital electronic patient record for comparative analysis. We aim to recruit at least 40 patients in total. One blood sample, ~10 mL (or 2 teaspoons), will be collected from patients, prior to thrombolysis treatment or on arrival, another one at 1 or 2 hours from the time of thrombolysis or from the time of arrival, then again at 24 hours and 72 hours. Plasmin levels and other immunological parameters will be analysed in these samples, and also in patient’s routine clinical bloods, at the Australian Centre of Blood Diseases on the Alfred campus.

The results of this study are expected to expand our understanding on the mechanisms of thrombolysis and potentially improve future stroke therapeutics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 111326 0
Prof Geoffrey Cloud
Address 111326 0
Department of Neurology
Alfred Hospital
55 Commercial Road, Melbourne
VIC 3004
Country 111326 0
Australia
Phone 111326 0
+61 03 90762552
Fax 111326 0
Email 111326 0
[email protected]
Contact person for public queries
Name 111327 0
Prof Geoffrey Cloud
Address 111327 0
Department of Neurology
Alfred Hospital
55 Commercial Road, Melbourne
VIC 3004
Country 111327 0
Australia
Phone 111327 0
+61 03 90762552
Fax 111327 0
Email 111327 0
[email protected]
Contact person for scientific queries
Name 111328 0
Prof Geoffrey Cloud
Address 111328 0
Department of Neurology
Alfred Hospital
55 Commercial Road, Melbourne
VIC 3004
Country 111328 0
Australia
Phone 111328 0
+61 03 90762552
Fax 111328 0
Email 111328 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?

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.