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| Name | Class |
|---|---|
| Emergency Medicine Foundation | OTHER |
| National Blood Authority | OTHER |
| Australian Red Cross | OTHER |
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12. No previous studies comparing FC and Cryoprecipitate in bleeding paediatric trauma patients 13. Fibrinogen supplementation will be guided by an accepted ROTEM targeted treatment algorithm 14. Pilot, multi-centre randomised controlled trial comparing FC to Cryoprecipitate (current standard practise in fibrinogen supplementation) 15. Hypothesis: Fibrinogen replacement in severe traumatic haemorrhage can be achieved quicker with a more predictable dose response using Fibrinogen Concentrate compared to Cryoprecipitate 16. It is imperative that robust and clinically relevant trials are performed to investigate fibrinogen supplementation in paediatric trauma patients before widespread adoption makes performing such studies unfeasible
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrinogen Concentrate | Experimental | Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM (FIBTEM) FIBTEM A5 0mm = 60mg/kg FC FIBTEM A5 1-4mm = 50mg/kg FC FIBTEM A5 5-6mm = 40mg/kg FC FIBTEM A5 7-8mm = 30mg/kg FC FIBTEM A5 9-10mm = 20mg/kg FC |
|
| Cryoprecipitate | Active Comparator | Fibrinogen Replacement using Cryoprecipitate as per ROTEM (FIBTEM) FIBTEM A5 0mm = 6ml/kg Cryoprecipitate FIBTEM A5 1-4mm = 5ml/kg Cryoprecipitate FIBTEM A5 5-6mm = 4ml/kg Cryoprecipitate FIBTEM A5 7-8mm = 3ml/kg Cryoprecipitate FIBTEM A5 9-10mm = 2ml/kg Cryoprecipitate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrinogen Concentrate | Drug | Experimental |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to administration of fibrinogen replacement from time of identification of hypofibrinogenaemia requiring fibrinogen replacement | Time to fibrinogen replacement | 3 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Transfusion Requirements | In number of units of Packed Red Blood Cells, Plasma, FC, Cryoprecipitate, Platelets, Prothrombin Complex Concentrate at 4, 6, 24, 48hrs | Up to 48 hours after Trauma Unit presentation |
| Duration of bleeding episode or time until surgical control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James Winearls, MBBS | Contact | +61756875684 | james.winearls@health.qld.gov.au | |
| Elizabeth Wake, BN | Contact | +61756874149 | elizabeth.wake@health.qld.gov.au |
| Name | Affiliation | Role |
|---|---|---|
| Shane George, MBBS | Lady Cilento Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Westmead Childrens Hospital | Recruiting | Sydney | New South Wales | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35508351 | Derived | George S, Wake E, Jansen M, Roy J, Maconachie S, Paasilahti A, Wiseman G, Gibbons K, Winearls J; FEISTY Investigators. Fibrinogen Early In Severe paediatric Trauma studY (FEISTY junior): protocol for a randomised controlled trial. BMJ Open. 2022 May 4;12(5):e057780. doi: 10.1136/bmjopen-2021-057780. |
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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D006470 | Hemorrhage |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D005340 | Fibrinogen |
| C026912 | cryoprecipitate coagulum |
| ID | Term |
|---|---|
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Cryoprecipitate | Drug | Comparator |
|
Duration bleeding episode |
| It is anticipated that haemorrhage control will be achieved within 12 hours |
| Intensive Care Unit LOS | ICU LOS | 1 Year |
| Hospital LOS | Hospital LOS | 1 Year |
| Adverse Events | Transfusion related adverse events, Sepsis, Multiple Organ Failure, Acute Renal Failure, Symptomatic Thromboembolic Complications | 1 Year |
| All Cause Mortality | Mortality at 4, 6, 24 hours and up to 90 days | Up to 90 Days |
| Functional Outcomes GOS-E Paediatrics | Functional Outcome Measures at 60 and 90 Days | Up to 90 Days |
| Royal Brisbane and Women's Hospital | Recruiting | Brisbane | Queensland | 4029 | Australia |
|
| Lady Cilento Children's Hospital | Recruiting | Brisbane | Queensland | 4101 | Australia |
|
| Princess Alexandra Hospital | Recruiting | Brisbane | Queensland | 4102 | Australia |
|
| Cairns Hospital | Recruiting | Cairns | Queensland | 4211 | Australia |
|
| Gold Coast University Hospital | Recruiting | Gold Coast | Queensland | 4215 | Australia |
|
| Mackay Base Hospital | Recruiting | Mackay | Queensland | 4211 | Australia |
|
| Rockhampton Hospital | Recruiting | Rockhampton | Queensland | 4211 | Australia |
|
| Townsville Hospital | Recruiting | Townsville | Queensland | 4814 | Australia |
|
| Royal Adelaide Hospital | Recruiting | Adelaide | South Australia | Australia |
|
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001779 |
| Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |