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Trial registered on ANZCTR


Registration number
ACTRN12611001258943
Ethics application status
Approved
Date submitted
18/11/2011
Date registered
7/12/2011
Date last updated
8/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of implication of Massive Transfusion Guidelines in conjunction with incidence of coagulopathy and outcome in the Northern Tasmania
Scientific title
Assessment of implication of Massive Transfusion Guidelines in conjunction with incidence of coagulopathy and outcome in the Northern Tasmania
Secondary ID [1] 273408 0
None
Universal Trial Number (UTN)
Trial acronym
MTP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Massive bleeding defined by the replacement of one blood volume in a period of 24 hrs or replacement of 50% of the total blood volume within three hours, or a rate of loss of 150 ml/hr, which is more relevant in the acute clinical setting. 279202 0
Condition category
Condition code
Blood 279404 279404 0 0
Haematological diseases
Blood 285542 285542 0 0
Clotting disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients that are requiring massive transfusion protocol (MTP) are included in this study after the initial issue and use of 4 Packed Red Cells Units (about half of blood volume) with foreseeable further blood transfusion.
The MTP is activated as following
MTP; Phase I protocol:
4 units Packed Red Cells + 2 units Fresh Frozen Plasma (300 ml each) + 1 Adult dose of platelets (depending upon availability)
When notifying the ward that blood products are ready ask if they are continuing with the Massive Transfusion Protocol, if so continue by:
Alternating with
MTP; Phase II protocol:
4 units Packed Red Cells + 2 units Fresh Frozen Plasma (300 ml each) + 10 units Cryoprecipitate
The requested physician at (Emergency Dept, Intensive care Unit (ICU) ot Theatre) will be asked when the blood products are delivered if they are continuing with the Massive Transfusion Protocol, and if so will continue alternating the above products as per protocol.
After 10 units of packed cells have been issued ABO and Rh compatible blood may be issued at the discretion of the on-call Clinical Haematologist.

This protocol was established by A/Professor A. Khalafallah in Sept 2007 at the Launceston General Hospital, Tasmania, Australia.
The observation will be for 6 months for each subject.
Intervention code [1] 283744 0
Not applicable
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 285979 0
Assessment of outcome of use of MTP in a single institution since 2007.
Tools/methods: Full blood count (FBC), Coagulation parameters; use of different blood products and outcome of MTP.
Timepoint [1] 285979 0
Will be assessed by the end of study.
Secondary outcome [1] 294890 0
Assessment of the incidence Disseminated intravascular coagulation (DIC).
Tools: Coagulation parameters such as APTT, PT, Fibrinogen and Di Dimer; use of different coagulation factors such as FFP, Cryopricipitate and others (ativated factor VIIa, prothrombin complex etc..).
Timepoint [1] 294890 0
Will be assessed by the end of study.

Eligibility
Key inclusion criteria
Patients from both sexes who presents with masive bleeding during the study period and who required MTP defined by transfusion of whole blood volume within 24 hours or replacement of half blood volume within 4 hours with ongoing need for transfusion.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are not considered as per definition as massive transfusion

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/09/2010
Actual
1/01/2008
Date of last participant enrolment
Anticipated
Actual
31/01/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 284226 0
Hospital
Name [1] 284226 0
Launceston General Hospital
Country [1] 284226 0
Australia
Funding source category [2] 284340 0
Charities/Societies/Foundations
Name [2] 284340 0
Clifford Craig Medical Trust Fund
Country [2] 284340 0
Australia
Primary sponsor type
Other
Name
none
Address
none
Country
Australia
Secondary sponsor category [1] 283282 0
University
Name [1] 283282 0
University of Tasmania, School of Human Life Sciences
Address [1] 283282 0
School of Human Life Sciences and School of Medicine
Charles street
Launceston, Tasmania 7250
Australia
Country [1] 283282 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286189 0
Tasmanian Human Research Ethics Committee
Ethics committee address [1] 286189 0
University of Tasmania
Private Bag 01
Hobart, Tas 7001
Australia
Ethics committee country [1] 286189 0
Australia
Date submitted for ethics approval [1] 286189 0
Approval date [1] 286189 0
22/09/2010
Ethics approval number [1] 286189 0
H0011432

Summary
Brief summary
Massive transfusion (MT) is associated with serious often fatal complications including intractable disseminated intravascular coagulopathy (DIC). Therefore there is a growing need for guidelines and protocols that are addressing this issue. At a single institution we have implemented a MT-Protocol (MTP) in late 2007 and studied prospectively all patients (105) from Jan 2008 to Jan 2011 who required MT defined by replacement of half of blood volume within 4 hours with ongoing need for transfusion. The MTP included two phases and incorporated fixed volume of fresh frozen plasma (FFP), cryoprecipitate and platelets in addition to packed RBCs.
The Launceston General Hospital is a tertiary referral centre for the North of Tasmania. This study will analyse data for the entire cohort of patients in Northern Tasmania who required Massive Transfusion.The main objective of the MTP is to provide appropriate and standardized different blood component therapy to prevent exsanguination, coagulopathy and thrombocytopaenia from occurring with subsequent inferior outcome.
This study is aiming to avoid DIC and cease microbleeding as early as psossibel in MT setting and hence improving outcome. We conducted this study to demonstrate whether replacement of coagulation factors and platelets in timely fashion will influence outcome and also reduce DIC.
This study, if published will deliver evidence based on local practice for a cohort of approximately 100-150 patients. This evidence would substantially improved evidence-based practice in trauma, surgery and emergency medicine.
Trial website
Trial related presentations / publications
Khalafallah A, Albarzan AM, Ganguly A, Bates G, Gavin F, et al.
(2012) Application of Massive Transfusion Protocol is Associated with Low
Incidence of Coagulopathy and Mortality Rate. J Blood Disord Transfus 3:123.
doi:10.4172/2155-9864.1000123
http://www.omicsonline.org/application-of-massive-transfusion-protocol-is-associated-with-a-low-incidence-of-coagulopathy-and-mortality-rate-2155-9864.1000123.pdf
Public notes

Contacts
Principal investigator
Name 33407 0
Prof Professor Alhossain Khalafallah
Address 33407 0
Launceston General Hospital
Charles Street
TAS 7250
Country 33407 0
Australia
Phone 33407 0
+61367776777
Fax 33407 0
Email 33407 0
[email protected]
Contact person for public queries
Name 16654 0
Prof Professor Alhossain A. Khalafallah
Address 16654 0
Launceston General Hospital
Charles Street, Launceston, TAS 7250
Australia
Country 16654 0
Australia
Phone 16654 0
+61373487111
Fax 16654 0
+61373487695
Email 16654 0
[email protected]
Contact person for scientific queries
Name 7582 0
Prof Professor Alhossain A. Khalafallah
Address 7582 0
Launceston General Hospital
Charles Street, Launceston, TAS 7250
Australia
Country 7582 0
Australia
Phone 7582 0
+61373487111
Fax 7582 0
+61373487695
Email 7582 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

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