Evaluating the effects of early administration of fibrinogen concentrate in adults with major traumatic haemorrhage.

Conditions

Topic: Injuries and Emergencies, Haematology

Nicola Curry, Claire Foley, Henna Wong, Ana Sabrina Mora, Elinor Curnow et al. (15 authors)

Critical Care2018-06-18100 citations

10.1186/s13054-018-2086-x

Fibrinogen Early In Severe Trauma studY (FEISTY): study protocol for a randomised controlled trial.

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.

2017-05-2643 citations

10.1186/s13063-017-1980-x

Interventions

Early supplementation of Fibrinogen concentrate (FgC) in patients with major traumatic haemorrhage. Patients will be randomised to receive either 6g fibrinogen concentrate or placebo within 45 minutes

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent or agreement, or waiver of consent, is obtained before any study related activity 2. The participant is judged to be an adult (aged 16 years or over) and is affected by traumatic injury 3. The participant is deemed by the attending clinician to have ongoing active haemorrhage with shock AND REQUIRES: 4. Activation of the local major haemorrhage protocol for management of severe blood loss and/or transfusion of emergency (Group O) red cells

Exclusion criteria

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 TBI or unsalvageable head injury

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 24/08/2018: 1. Mean fibrinogen levels over time by treatment arm at admission, At 2 hours from admission during first active haemorrhage and 7 days from admission Previous primary outcome measures: 1. Feasibility of administering fibrinogen concentrate within 45 minutes of admission. 2. Proportion of patients with at least one Clauss fibrinogen level = 2 g/L during active haemorrhage.	—

Measure

Time frame

Current primary outcome measure as of 24/08/2018: 1. Mean fibrinogen levels over time by treatment arm at admission, At 2 hours from admission during first active haemorrhage and 7 days from admission Previous primary outcome measures: 1. Feasibility of administering fibrinogen concentrate within 45 minutes of admission. 2. Proportion of patients with at least one Clauss fibrinogen level = 2 g/L during active haemorrhage.

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Secondary

Measure	Time frame
Current secondary outcome measure as of 24/08/2018: 1. Transfusion volumes, in numbers of units, for red cells, plasma, platelets and cryoprecipitate at 3, 6 hours and 24 hours from admission Previous secondary outcome measures: 1. Transfusion volumes, in numbers of units, for red cells, plasma, platelets and cryoprecipitate at 3, 6 hours and 24 hours from admission 2. Clauss fibrinogen levels at day 7 post randomisation 3. ROTEM measures of coagulation (EXTEM and FIBTEM, where available) to day 7 post randomisation 4. Thrombotic events: clinically apparent venous thromboembolism (DVT, PE) and arterial events (MI, stroke) to day 28 from randomisation 5. Duration of and/or requirement for organ support to day 28 from admission, as defined by the CTCOFR score 6. All-cause mortality (including death from bleeding) at 3, 6 and 24 hours and up to day 28 from admission. Mortality at 1 year by longer term follow up 7. Hospital stay including ICU/HDU stay 8. Quality of life at 28 day from admission 9. Proportion of patients achieving haemostasis at 3 hours from admission (defined using a trial specific haemorrhage assessment tool)	—

Measure

Time frame

Current secondary outcome measure as of 24/08/2018: 1. Transfusion volumes, in numbers of units, for red cells, plasma, platelets and cryoprecipitate at 3, 6 hours and 24 hours from admission Previous secondary outcome measures: 1. Transfusion volumes, in numbers of units, for red cells, plasma, platelets and cryoprecipitate at 3, 6 hours and 24 hours from admission 2. Clauss fibrinogen levels at day 7 post randomisation 3. ROTEM measures of coagulation (EXTEM and FIBTEM, where available) to day 7 post randomisation 4. Thrombotic events: clinically apparent venous thromboembolism (DVT, PE) and arterial events (MI, stroke) to day 28 from randomisation 5. Duration of and/or requirement for organ support to day 28 from admission, as defined by the CTCOFR score 6. All-cause mortality (including death from bleeding) at 3, 6 and 24 hours and up to day 28 from admission. Mortality at 1 year by longer term follow up 7. Hospital stay including ICU/HDU stay 8. Quality of life at 28 day from admission 9. Proportion of patients achieving haemostasis at 3 hours from admission (defined using a trial specific haemorrhage assessment tool)

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Countries

England, Scotland, United Kingdom

Outcome results

None listed