Trauma patients whereby the local major haemorrhage protocol has been activated MedDRA version: 18.0 Level: LLT Classification code 10044461 Term: Trauma System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Riastap 1g
Product Name: Fibrinogen Concentrate, Human
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Fi
Sponsors
NHS Blood & Transplant
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 on-going 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 Are the trial subjects under 18? yes Number of subjects for this age range: 5 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 35 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
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 |
|---|---|
| Main Objective: This study will investigate the following: • feasibility of administration FgC within 45 minutes of admission to ED, where the aim will be to administer the FgC at the earliest possible time • effects of early FgC supplementation on laboratory biomarkers during major traumatic haemorrhage ; Secondary Objective: The secondary objectives are to compare trends between the groups for adverse events, death, transfusion requirements, duration of in patient stay, duration/requirement for organ support, quality of life and fibrinogen levels which would inform the power calculation for a larger clinical trial. ; Primary end point(s): The E-FIT Study is a pilot feasibility trial which will investigate: -Feasibility of administering FgC within 45 minutes of admission -Proportion of patients with at least one Clauss fibrinogen level = 2 g/L during active haemorrhage ; Timepoint(s) of evaluation of this end point: Administration of FgC - within 45 minutes of admission to the emergency department Maintenance of Fg blood levels - within the first active haemorrhage | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mortality rate: 3 hours, 6 hours, 24hours and 28 days from admission Transfusion requirements, in numbers of units, for RBC, platelets, FFP & cryoprecipitate at 3, 6 and 24 hours from admission Duration and/or requirement for organ support to day 28 In patient stay including ICU/HDU stay ROTEM measures of coagulation: EXTEM and FIBTEM (where available) Clauss fibrinogen levels at day 7 post admission Quality of life Mortality at 1 year by longer term follow up Proportion of patients achieving haemostasis at 3 hours after admission (using a trial specific haemorrhage assessment tool). The haemorrhage assessment tool will be piloted during this study to evaluate its utility for future definitive trials. ;Timepoint(s) of evaluation of this end point: Timepoints specified above | — |
Countries
United Kingdom
Contacts
Public ContactClaire Foley
NHS Blood & Transplant CTU
Outcome results
None listed