Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000777594
Ethics application status
Approved
Date submitted
24/06/2015
Date registered
27/07/2015
Date last updated
21/07/2022
Date data sharing statement initially provided
21/07/2022
Date results information initially provided
21/07/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective Longitudinal Evaluation of Coagulation with Novel Thromboelastography Technology in Patients after Subarachnoid Hemorrhage - A Pilot Study
Scientific title
Prospective Longitudinal Evaluation of Coagulation with Novel Thromboelastography Technology in Patients after Subarachnoid Hemorrhage - A Pilot Study
Secondary ID [1] 286962 0
Nil
Universal Trial Number (UTN)
Trial acronym
TEG use in SAH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subarachnoid haemorrhage 295420 0
Hypercoagulability 295424 0
Condition category
Condition code
Blood 295676 295676 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The study involves a simple, point of care test of blood clotting - thromboelastogram (TEG) that measures increased clotting susceptibility far better than other conventional blood tests. These blood test results will be correlated against longer term progress of patients neurological recovery. The outcome test will use standard CT scan, serial Doppler Ultrasound for brain blood vessels and neurological information obtained during routine followup by neurosurgeons and neurologists. The blood for the TEG will be taken together with other routine blood tests and should not usually require separate blood samples. The neurological assessments will be part of routine care.
Tests will be collected within 24-48hours of diagnosis and serially assessed against other conventional methods up to day 14 of diagnosis or discharge.
Intervention code [1] 292167 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295379 0
Correlation of TEG hypercoagulability in patients post SAH and stroke volume assessed by radiological imaging studies such as CT Brain Perfusion, Angiography and/or MRI
Timepoint [1] 295379 0
At baseline, 2 weeks after diagnosis
Primary outcome [2] 295497 0
Neurological functional assessment by modified Rankin score
Timepoint [2] 295497 0
at baseline and at 3 months after diagnosis
Primary outcome [3] 295498 0
Mortality in 30 days
Timepoint [3] 295498 0
4 weeks after Diagnosis of SAH
Secondary outcome [1] 315474 0
correlate TEG markers of coagulation with grading of vasospasm assessed by Digital Subtraction Angiogram, Trans-cranial Doppler
Timepoint [1] 315474 0
at 2 weeks after diagnosis
Secondary outcome [2] 412130 0
Changes of hypercoagulability components using repeated TEG parameters (R-time, Maximum amplitude, Functional fibrinogen) using TEG6s on days 1, 2, 3, 5, 7, 10 and 14 and conventional blood testing of platelets and fibrin over the same time.
Grading of vasospasm is assessed based on the formal radiological reports of Digital Subtraction Angiogram, or Transcranial Doppler.
Timepoint [2] 412130 0
2 weeks after diagnosis of SAH

Eligibility
Key inclusion criteria
- Adult patients (aged 18 years or older)
- We will include patients who are diagnosed with subarachnoid haemorrhage based on the following criteria
1.CT brain (non contrast, contrast or infusion) showing bleeding.
2.Digital Subtraction cerebral angiography.
3.MRI Brain, MRA
4.Positive Lumbar puncture with CSF analysis if CT head negative post 6 hours of presentation.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Traumatic causes of SAH
Refusal to consent for enrolment of the study.
Unable to obtain consent from self or relative.
Death is expected within the next 24 hours.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We anticipate that approximately 50 patients would be suitable for the study within a period of 2 years, assuming 50% recruitment rate.
No statistical calculations were performed to support sample size.
We will correlate TEG markers of coagulation with grading of vasospasm and the degree of cerebral infarction by means of Spearman rho correlation test.We will compare coagulation characteristics of patients with or without vasospasm using non-parametric statistics. We will describe changes in TEG derived variables over time using analysis of variance.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
4/05/2015
Actual
4/05/2015
Date of last participant enrolment
Anticipated
29/05/2017
Actual
31/05/2017
Date of last data collection
Anticipated
Actual
30/09/2017
Sample size
Target
50
Accrual to date
Final
14
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 3962 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 9869 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 291519 0
Charities/Societies/Foundations
Name [1] 291519 0
Austin Medical Research Foundation
Country [1] 291519 0
Australia
Primary sponsor type
Individual
Name
Dr Khaled El-Khawas
Address
Intensive Care Department
Austin Hospital
145 Studley Road,
Heidelberg, VIC 3084.
Country
Australia
Secondary sponsor category [1] 290201 0
Individual
Name [1] 290201 0
Dr Graeme Hart
Address [1] 290201 0
Intensive Care Department
Austin Health
145 Studley Road, Heidelberg 3084
Victoria, Australia
Country [1] 290201 0
Australia
Secondary sponsor category [2] 290202 0
Individual
Name [2] 290202 0
Dr Glenn Eastwood
Address [2] 290202 0
Department of Intensive Care
Austin Hospital
145 Studley Road,
Heidelberg
VIC 3084
Country [2] 290202 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293062 0
Austin Health HREC
Ethics committee address [1] 293062 0
145 Studley Road
Heidelberg
Victoria, 3084
Ethics committee country [1] 293062 0
Australia
Date submitted for ethics approval [1] 293062 0
Approval date [1] 293062 0
02/02/2015
Ethics approval number [1] 293062 0
LNR/14/Austin/485

Summary
Brief summary
When patients suffer from bleeding into the subarachnoid space surrounding the brain it is known as a “Subarachnoid Haemorrhage” (SAH). When a SAH is suffered the patient is exposed to very high risk of death and long-term illness and disability. This is due to development of multiple complications following the start of the bleeding. The cause of these complications can be attributed directly to the cause of the bleeding in the first place. Examples include thinning of the blood, trauma or aneurysms (a weakness in the wall of the brain arteries that become enlarged and rupture). However, one of the most serious complications of subarachnoid bleeding occurring 3 to 7 days after bleeding is a phenomenon called vasospasm. This phenomenon in which the blood vessels narrow and decrease the blood flow, reducing the blood supply and oxygen delivery to the brain tissue, potentially causing permanent brain damage ( stroke) . It can be fatal if severe.

The causes of vasospasm and subsequent brain damage are not fully understood.

Understanding the causes of vasospasm and the way it causes brain damage could help in starting new treatment lines that eventually might lead to a better outcome.

We believe that increased blood clotting could be a contributing factor in reducing blood flow to the brain causing permanent blockage of brain blood vessels and brain damage.

Therefore, our study seeks to determine whether patients who develop symptoms of delayed brain damage have an increased blood clotting tendency. The study involves a simple, point of care test of blood clotting - thromboelastogram (TEG) that measures increased clotting susceptibility far better than other conventional blood tests. These blood test results will be correlated against longer term progress of patients neurological recovery. The outcome test will use standard CT scan, serial Doppler Ultrasound for brain blood vessels and neurological information obtained during routine followup by neurosurgeons and neurologists. The blood for the TEG will be taken together with other routine blood tests and should not usually require separate blood samples. The neurological assessments will be part of routine care.

Some blood plasma may be stored for additional coagulation tests depending on the primary result of the study.

All information gathered will be aggregated and no individual patient would be identified in any publication.

This study is prospective cross sectional cohort study and use thromboelastogram in patients with subarachnoid bleeding excluding trauma related causes. We suspect that there will be association between brain damage symptoms and increasing coagulation of the blood. That will facilitate, in future studies, introducing medical intervention earlier to assist in treating such morbid complication.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 511 511 0 0
/AnzctrAttachments/368815-20150202 LETTER - LNR14Austin485 LNRR application single site - APPROVED.pdf

Contacts
Principal investigator
Name 58318 0
Dr Khaled El-Khawas
Address 58318 0
Intensive care Unit
Austin Health,
145 Studley Road,
Heidelberg
VIC, 3084
Country 58318 0
Australia
Phone 58318 0
+61 3 9496 5992
Fax 58318 0
Email 58318 0
[email protected]
Contact person for public queries
Name 58319 0
A/Prof Glenn Eastwood
Address 58319 0
ICU Research Manager
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg, Victoria 3084
Country 58319 0
Australia
Phone 58319 0
+61 3 9496 4835
Fax 58319 0
+61 3 9496 3932
Email 58319 0
[email protected]
Contact person for scientific queries
Name 58320 0
A/Prof Dr Graeme Hart
Address 58320 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg, Victoria 3084
Country 58320 0
Australia
Phone 58320 0
+61 3 9496 5916
Fax 58320 0
Email 58320 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
as per publication


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16711Ethical approval    368815-(Uploaded-13-01-2020-10-39-10)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes 27 December 2019 doi: 10.1016/j.wneu.2019.12.109 ... [More Details]

Documents added automatically
No additional documents have been identified.