Trauma patients with major bleeding or occult bleeding who received volume replacement MedDRA version: 18.0 Level: LLT Classification code 10018988 Term: Haemorrhage NOS System Organ Class: 100000004866
Conditions
Interventions
Trade Name: CLOTTAFACT
Product Name: CLOTTAFACT
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Human Fibrinogen
CAS Number: 9001-32-5
Current Sponsor code: FGT
Sponsors
Medizinische Universität Innsbruck / Univ.-Klinik für Allgem. u. Chirurg. Intensivmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I.1) Trauma patient I.2) Patient at the obvious age of = 18 years of either sex I.3) Major bleeding or occult bleeding I.4) Need for volume replacement therapy I.5) Patient, who will be admitted to one of the participating hospitals Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: E.1) Solely penetrating trauma E.2) Solely head injury E.3) In case of ongoing severe hemodynamic instability refractory to therapy (vasopressor volume) E.4) Patient with inevitable lethal course as evaluated by emergency physician E.5) Need for CPR on the scene E.6) Deep hypothermia (<30°C) E.7) Obviously pregnant women E.8) Patient with known recent history of thromboembolic events within the last 6 months E.9) Patient known to be on anticoagulant therapy E.10) Patient with known refusal of a participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether the ultra-early pro-coagulatory treatment with fibrinogen concentrate on the scene would improve plasmatic coagulation capacity in multiple trauma patients with bleeding and/or major blood loss.;Secondary Objective: - to assess biological and clinical safety;Primary end point(s): Change from baseline (before FGTW administration) to hospital admission (T2) in MCF FibtEM® (Maximum Clot Firmness) – as the measure of fibrinogen polymerisation capacity.;Timepoint(s) of evaluation of this end point: T1 and T2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Other ROTEM® parameters and coagulation tests - Number of thrombosis after 7 days assessed by duplex sonography;Timepoint(s) of evaluation of this end point: - T1 - T8 - T7 | — |
Countries
Australia, Austria, Czech Republic, Germany
Contacts
Public ContactStudienbüro von Dr. Fries
Medizinische Universität Innsbruck
Outcome results
None listed