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Trial registered on ANZCTR


Registration number
ACTRN12614000198628
Ethics application status
Not yet submitted
Date submitted
11/02/2014
Date registered
25/02/2014
Date last updated
25/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Critical Evaluation of a Targeted Point of Care (POC) ROTEM (Registered Trademark) and Multiplate (Registered Trademark) Guided Coagulation and Haemostasis Management Programme in Severe Trauma and Critical Bleeding
Scientific title
Critical Evaluation of a Targeted Point of Care (POC) ROTEM (Registered Trademark) and Multiplate (Registered Trademark) Guided Coagulation and Haemostasis Management Programme in Severe Trauma and Critical Bleeding
Secondary ID [1] 284078 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma 291138 0
Critical Bleeding 291139 0
Coagulation Disturbance 291175 0
Condition category
Condition code
Blood 291482 291482 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
ROTEM / Multiplate targeted transfusion protocol.

The primary aim is to validate the use of a Targeted Point of Care (POC) ROTEM (Registered Trademark) and Multiplate (Registered Trademark) Guided Coagulation and Haemostasis Management Programme in Trauma and Critically Bleeding patients.

Trauma and critically bleeding patients undergoing treatment at the Gold Coast University Hospital will be managed according to a POC ROTEM and Multiplate targeted coagulation and haemostatic programme. Our programme has been established with rigorous quality assurance and quality control procedures in accordance with strict clinical governance guidelines.

Treatment algorithms have been developed from normal reference ranges reported in the literature and from peer reviewed algorithms in the medical literature from experienced centres.


Anthropometric measurements will be obtained at admission before collecting about 5 mL venous blood in sodium citrate tubes for analysis on ROTEM and Multiplate at baseline:

- On arrival in the Emergency department in trauma patients
- Recognition of significant bleeding
- After initial baseline blood testing another venous blood sample will be collected 10 minutes post haemostatic intervention until haemorrhage control is achieved or as directed by treating clinician.

ROTEM tests (EXTEM, INTEM, FIBTEM and APTEM) and Multiplate tests (ADP, ASPI, TRAP) will be performed according to manufacturer’s recommendations.

Multiplate testing will be performed on all patients with an altered level of consciousness who are unable to provide a history and those patients currently taking anti-platelet agents.

All other aspects of care will be as per standard GCUH Trauma Management Guidelines.
Intervention code [1] 288771 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291456 0
Blood and Blood Product Transfusion Rates
Timepoint [1] 291456 0
1 year
Primary outcome [2] 291457 0
Blood and blood product transfusion related complications - TACO/TRALI/MOF/Acute Renal Failure/Sepsis
This will be ascertained from patient physiological variables,imaging and laboratory results.
Timepoint [2] 291457 0
1 year
Secondary outcome [1] 306821 0
Blood and blood product cost
This data will be accessed from GCUH Blood Bank records
Timepoint [1] 306821 0
1 year
Secondary outcome [2] 306822 0
Mortality at 30 / 60 /90 days
Timepoint [2] 306822 0
1 year
Secondary outcome [3] 306823 0
In depth analysis of the coagulation disturbances induced by severe trauma and critical bleeding. With particular reference to:

- Fibrinogen and Platelet contribution to coagulation
- Hyperfibrinolysis related coagulopathy

This data will be ascertained from ROTEM and Multiplate sample analysis
Timepoint [3] 306823 0
1 year

Eligibility
Key inclusion criteria
Severe Trauma: (one of)
- Trauma Call
- > 2 Body Areas Involved
- Significant mechanism of injury

Bleeding: (2 out of 3)
- > 2 Units PRBC's in 2 hrs
- Drop in Hb > 2g/l in 2 hours
Haemodynamic instability
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18 years
Futility of therapy or Imminent death expected

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2014
Actual
Date of last participant enrolment
Anticipated
1/03/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 2078 0
Gold Coast Hospital - Southport
Recruitment postcode(s) [1] 7770 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 288709 0
Hospital
Name [1] 288709 0
Gold Coast University Hospital
Country [1] 288709 0
Australia
Primary sponsor type
Hospital
Name
Gold Coast University Hospital Critical Care Research Group
Address
1 Hospital Boulevard
Southport
QLD
4215
Country
Australia
Secondary sponsor category [1] 287411 0
None
Name [1] 287411 0
Address [1] 287411 0
Country [1] 287411 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290545 0
Gold Coast University Hospital HREC
Ethics committee address [1] 290545 0
Ethics committee country [1] 290545 0
Australia
Date submitted for ethics approval [1] 290545 0
12/02/2014
Approval date [1] 290545 0
Ethics approval number [1] 290545 0
EC00160

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46190 0
Dr James Winearls
Address 46190 0
Gold Coast University Hospital
1 Hospital Boulevard
Southport
QLD
4215
Country 46190 0
Australia
Phone 46190 0
+61756875684
Fax 46190 0
Email 46190 0
[email protected]
Contact person for public queries
Name 46191 0
James Winearls
Address 46191 0
Gold Coast University Hospital
1 Hospital Boulevard
Southport
QLD
4215
Country 46191 0
Australia
Phone 46191 0
+61756875684
Fax 46191 0
Email 46191 0
[email protected]
Contact person for scientific queries
Name 46192 0
James Winearls
Address 46192 0
Gold Coast University Hospital
1 Hospital Boulevard
Southport
QLD
4215
Country 46192 0
Australia
Phone 46192 0
+61756875684
Fax 46192 0
Email 46192 0
[email protected]

No information has been provided regarding IPD availability


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.