Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001293550p
Ethics application status
Submitted, not yet approved
Date submitted
23/11/2015
Date registered
27/11/2015
Date last updated
27/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
FIT
A pilot study evaluating the feasibility and effects of early administration of Fibrinogen concentrate In adults with Traumatic haemorrhage
Scientific title
To determine the feasibility of early administration of Fibrinogen concentrate in trauma patients with ongoing haemorrhagic shock requiring activation of the massive transfusion protocol
Secondary ID [1] 287969 0
Nil
Universal Trial Number (UTN)
Trial acronym
FIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bleeding 296846 0
Traumatic haemorrhage 296874 0
Condition category
Condition code
Blood 297074 297074 0 0
Clotting disorders
Injuries and Accidents 297104 297104 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fibrinogen concentrate will be given via an infusion at the beggining of the massive transfusion protocol activation.
Dosage is a single 6g dose of FgC, 6x1gm vial reconstituted with 50ml saline per vial (RiaSTAP Registered Trademark, CSL Behring, Australia) IV given as a slow push injection over 5 minutes.
Intervention code [1] 293309 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296679 0
Proportion of patients receive Fibrinogen concentrate within 45 minutes of admission to hospital which will be determined from linkage to medical record information.
Timepoint [1] 296679 0
45 minutes from admission
Primary outcome [2] 296680 0
Proportion of patients with at least one Clauss fibrinogen level greater than or equal to 2 g/L during active haemorrhage.
Timepoint [2] 296680 0
Fibrinogen levels will be tested at 3, 6 and 24 hours following study treatment.
Secondary outcome [1] 319103 0
Transfusion volumes, in numbers of units, for red cells, plasma, platelets and cryoprecipitate as reported in the medical records and pathology database.
Timepoint [1] 319103 0
3, 6 hours and 24 hours from admission
Secondary outcome [2] 319104 0
Clauss fibrinogen levels at day 7 post enrolment
Timepoint [2] 319104 0
day 7 post enrolment
Secondary outcome [3] 319105 0
Thrombotic events: venous thromboembolism (DVT, PE) and arterial events (MI, stroke) to day 28 from enrolment as reported in the patients medical record.
Timepoint [3] 319105 0
up to day 28
Secondary outcome [4] 319106 0
Duration of and/or requirement for organ support to day 28 from admission, as defined by the SOFA score
Timepoint [4] 319106 0
up to day 28 from admission
Secondary outcome [5] 319107 0
All-cause mortality (including death from bleeding) at 3, 6 and 24 hours and up to day 28 from admission
Timepoint [5] 319107 0
3, 6 and 24 hours and up to day 28 from admission
Secondary outcome [6] 319108 0
Hospital stay including ICU/HDU stay
Timepoint [6] 319108 0
Lenth of stay from hospital admission until hospital discharge.

Eligibility
Key inclusion criteria
1. The participant is judged to be an adult (aged 18 years or over) and is affected by traumatic injury
2. The participant is deemed by the attending clinician to have on-going active haemorrhage with shock
AND REQUIRES:
3. activation of the local massive transfusion protocol (MTP) for management of severe blood loss and/or transfusion of emergency (Group O) red cells
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. The participant has been transferred from another hospital
2. The trauma team leader deems the patient inappropriate for the trial i.e. injuries deemed to be incompatible with life
3. More than 3 hours have elapsed from the time of injury
4. The participant is pregnant
5. Severe isolated traumatic brain injury (TBI) or unsalvageable head injury
6. Known objection to the administration of human blood products
7. Participation in a competing study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/01/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 4704 0
The Alfred - Prahran
Recruitment postcode(s) [1] 12274 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 292437 0
Charities/Societies/Foundations
Name [1] 292437 0
Alfred Foundation
Country [1] 292437 0
Australia
Primary sponsor type
University
Name
Investigator Initiated- Monash University
Address
99 Commercial Rd Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 291130 0
None
Name [1] 291130 0
Address [1] 291130 0
Country [1] 291130 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 293896 0
Alfred Health Human Research Ethics Committee
Ethics committee address [1] 293896 0
Ethics committee country [1] 293896 0
Australia
Date submitted for ethics approval [1] 293896 0
25/11/2015
Approval date [1] 293896 0
Ethics approval number [1] 293896 0

Summary
Brief summary
One third of patients affected by severe trauma die from uncontrolled bleeding. Many of these patients are found to have abnormalities of the clotting system collectively known as ‘acute traumatic coagulopathy’ (ATC). The two most important abnormalities in ATC are a low fibrinogen and increased clot breakdown. It has been hypothesised, and there are some non-randomised studies that show that treatment with fibrinogen therapy in trauma patients who are bleeding can stop bleeding more effectively than standard care, reduce transfusion needs and may reduce death rates.
This study will look at the effects of infusing fibrinogen concentrate (FgC, a concentrated source of fibrinogen) to adult trauma patients as early as possible (within 45 minutes of admission to hospital). It has been shown in a large trauma randomised controlled trial that treatment for bleeding has better outcomes if delivered to patients quickly. This study will evaluate whether it is possible to enrol patients, deliver and infuse drug within 45 minutes and will also look at laboratory and clinical outcome measures.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61742 0
Prof D Jamie Cooper
Address 61742 0
Intensive Care Unit
Alfred Hospital
Commercial Rd
Melbourne
VIC
3004
Country 61742 0
Australia
Phone 61742 0
+61 3 9076 8806
Fax 61742 0
Email 61742 0
j.cooper@alfred.org.au
Contact person for public queries
Name 61743 0
Ms Bridget Ady
Address 61743 0
ANZIC-RC Monash University
The Alfred Centre
99 Commercial Rd
Melbourne
VIC
3004
Country 61743 0
Australia
Phone 61743 0
+61 3 9903 0035
Fax 61743 0
Email 61743 0
bridget.ady@monash.edu
Contact person for scientific queries
Name 61744 0
Dr Zoe McQuilten
Address 61744 0
ANZIC-RC Monash University
The Alfred Centre
99 Commercial Rd
Melbourne
VIC
3004
Country 61744 0
Australia
Phone 61744 0
+61 3 9903 0379
Fax 61744 0
Email 61744 0
zoe.mcquilten@monash.edu

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
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