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| Name | Class |
|---|---|
| Emergency Medicine Foundation | OTHER |
| National Blood Authority | OTHER |
| Australian Red Cross | OTHER |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibrinogen Concentrate | Experimental | Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm [FIBTEM ≤ A5 10mm] |
|
| Cryoprecipitate | Active Comparator | Fibrinogen replacement using Cryoprecipitate as per ROTEM guided treatment algorithm [FIBTEM A5 ≤ 10mm] |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrinogen Concentrate | Drug | Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm [FIBTEM ≤ A5 10mm] FIBTEM A5 0mm (Flat Line) = 6g FC FIBTEM A5 1 - 4mm = 5g FC FIBTEM A5 5 - 6mm = 4g FC FIBTEM A5 7 - 8mm = 3g FC FIBTEM A5 9 - 10mm = 2g FC |
| Measure | Description | Time Frame |
|---|---|---|
| Time to administration of Fibrinogen Replacement from time of ROTEM analysis indicating fibrinogen supplementation is required First dose of Fibrinogen Concentrate or Cryoprecipitate required | It is anticipated that fibrinogen replacement will occur with 3 hours Fibrinogen replacement will be with either FC or Cryroprecipitate depending on randomisation | 3 Hours |
| Feasibility of administering FC within 30 mins of clinical scenario and ROTEM analysis suggesting Fibrinogen replacement is required | Proportion of patients receiving FC within 30 minutes | 3 Hours |
| Effects on Fibrinogen levels during traumatic haemorrhage as measured by Clauss Fibrinogen | Blood sampling will occur for 7 days after admission/randomisation | 7 Days |
| Effects on Fibrinogen levels during traumatic haemorrhage as measured by FIBTEM | Blood sampling will occur for 7 days after admission/randomisation | 7 Days |
| 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 | 48 hours |
| Duration of bleeding episode or time until surgical control |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Winearls, MBBS | Gold Coast University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane and Women's Hospital | Brisbane | Queensland | 4029 | Australia | ||
| Princess Alexandra Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36163263 | Derived | Morrow GB, Feller T, McQuilten Z, Wake E, Ariens RAS, Winearls J, Mutch NJ, Laffan MA, Curry N. Cryoprecipitate transfusion in trauma patients attenuates hyperfibrinolysis and restores normal clot structure and stability: Results from a laboratory sub-study of the FEISTY trial. Crit Care. 2022 Sep 26;26(1):290. doi: 10.1186/s13054-022-04167-x. | |
| 28549445 |
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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 | Other | Fibrinogen replacement using Cryoprecipitate as per ROTEM guided treatment algorithm [FIBTEM A5 ≤ 10mm] FIBTEM A5 0mm (Flat Line) = 20 Units Cryo FIBTEM A5 1- 4mm = 16 Units Cryo FIBTEM A5 5 - 6mm = 14 Units Cryo FIBTEM A5 7 - 8mm = 10 Units Cryo FIBTEM A5 9 - 10mm = 8 Units Cryo |
|
It is anticipated that haemorrhage control will be achieved within 12 hours
| 12 hours |
| Intensive Care Unit Length of stay | 1 Year |
| Hospital Length of Stay | 1 Year |
| Adverse Events | Transfusion related adverse events Sepsis Multiple Organ Failure Acute Renal Failure Thromboembolic Complications | 1Year |
| All cause Mortality | Mortality at 4, 6, 24 hours and up to 90 days | 90 Days |
| Brisbane |
| Queensland |
| 4102 |
| Australia |
| Gold Coast University Hospital | Gold Coast | Queensland | 4215 | Australia |
| Townsville Hospital | Townsville | Queensland | 4814 | Australia |
| Winearls J, Wullschleger M, Wake E, Hurn C, Furyk J, Ryan G, Trout M, Walsham J, Holley A, Cohen J, Shuttleworth M, Dyer W, Keijzers G, Fraser JF, Presneill J, Campbell D. Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial. Trials. 2017 May 26;18(1):241. doi: 10.1186/s13063-017-1980-x. |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001779 |
| Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |