ANZCTR - Registration

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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 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]

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

Hypercoagulability

Condition category

Condition code

Blood

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]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

At baseline, 2 weeks after diagnosis

Primary outcome [2]

Neurological functional assessment by modified Rankin score

Timepoint [2]

at baseline and at 3 months after diagnosis

Primary outcome [3]

Mortality in 30 days

Timepoint [3]

4 weeks after Diagnosis of SAH

Secondary outcome [1]

correlate TEG markers of coagulation with grading of vasospasm assessed by Digital Subtraction Angiogram, Trans-cranial Doppler

Timepoint [1]

at 2 weeks after diagnosis

Secondary outcome [2]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Austin Medical Research Foundation

Address [1]

Austin Hospital
145-163 Studley Road, Heidelberg, 3084
Victoria, Australia

Country [1]

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]

Individual

Name [1]

Dr Graeme Hart

Address [1]

Intensive Care Department
Austin Health
145 Studley Road, Heidelberg 3084
Victoria, Australia

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Dr Glenn Eastwood

Address [2]

Department of Intensive Care
Austin Hospital
145 Studley Road,
Heidelberg
VIC 3084

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health HREC

Ethics committee address [1]

145 Studley Road
Heidelberg
Victoria, 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

02/02/2015

Ethics approval number [1]

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]

/AnzctrAttachments/368815-20150202 LETTER - LNR14Austin485 LNRR application single site - APPROVED.pdf

Contacts

Principal investigator

Name

Dr Khaled El-Khawas

Address

Intensive care Unit
Austin Health,
145 Studley Road,
Heidelberg
VIC, 3084

Country

Australia

Phone

+61 3 9496 5992

Fax

khaledelkhawas@gmail.com

Contact person for public queries

Name

Glenn Eastwood

Address

ICU Research Manager
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg, Victoria 3084

Country

Australia

Phone

+61 3 9496 4835

Fax

+61 3 9496 3932

glenn.eastwood@austin.org.au

Contact person for scientific queries

Name

Dr Graeme Hart

Address

Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg, Victoria 3084

Country

Australia

Phone

+61 3 9496 5916

Fax

graeme.hart@austin.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

as per publication

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
16711	Ethical approval					368815-(Uploaded-13-01-2020-10-39-10)-Study-related document.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.

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