Major trauma (Injury Severity Score, ISS >15), clinical signs/risk of blood loss and coagulopathy as measured by rotational thrombelastometry (ROTEM) MedDRA version: 14.0 Level: LLT Classification code 10018988 Term: Haemorrhage NOS System Organ Class: 10047065 - Vascular disorders
Conditions
Interventions
Trade Name: Haemocomplettan P
Product Name: Haemocomplettan P
Product Code: Blutgerinnungsfaktor 1
Pharmaceutical Form: Powder and solution for solution for injection
INN or Proposed INN: Human Fribri
Sponsors
Medizinische Universität Innsbruck / UK für Anästhesie und Intensivmedizin & UK für Allgem. u. Chirurg. Intensivmedizin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: I.1. Male and female subjects ? 18 years and 15) I.3. Clinical signs of ongoing bleeding or patients who are at risk for significant haemorrhage assessed and judged by the ED team in charge of patient I.4. Presence of coagulopathy defined by ROTEM assays as follows, o Patients with concomitant decreased fibrinogen polymerisation (ROTEM® FibTEM A10 of 90 sec) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: E.1. Lethal injury E.2. CPR on the scene, E.3. Isolated brain injury, burn injury E.4. Avalanche injury E.5. Administration of FFP or coagulation factor concentrates before ED admission E.6. Delayed (>6hours after trauma) admittance to ED E.7. Known use of oral anticoagulants, or platelet aggregation inhibitors within 5 days before injury E.8. Known history of severe allergic reaction to plasma products E.9. Known history of congenital hemostasis disturbance, IgA or Protein C deficiency E.10.Patients with a history of thromboembolic events or heparin induced thrombocytopenia (HIT) type 2 within the last year E. 11. Patients with a body weight 150kg E.12. Patients that are known to be pregnant E.13. Jehova‘s Witness E.14. known participation in another clinical trial E.15. Patient with known refusal of a participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the difference in incidence of multi organ failure (MOF) after treatment of trauma induced coagulopathy with Fresh frozen plasma (FFP) or Coagulation factor concentrates (CFC).;Primary end point(s): Occurrence of MOF as assessed by the Sequential Organ Failure Assessment score (SOFA) ;Secondary Objective: A secondary aim of the study is to investigate the frequency of treatment failure, whether or not coagulation test results, markers of inflammation and incidence of sepsis and lung injury differ between patients treated with CFC or FFP. A further goal of the study is to investigate whether or not in trauma patients a CFC based therapy results in an incidence of infections and thrombembolic events comparable to that observed with FFP treatment. Furthermore it will be evaluated whether the type of coagulation therapy influences transfusion requirements, ventilator-free days, length of ICU and hospital stay, and 24h and 30 day mortality. ;Timepoint(s) of evaluation of this end point: The primary endpoint of the study is the difference in incidence of MOF between the CFC and FFP groups. MOF will be assessed by the daily SOFA score (Sequential Organ Failure Assessment Score) calculated using appropriate software by the ICU team not involved in the initial trauma care. The SOFA score determines the extent of a person's organ function or rate of failure. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. Each organ is graded from 0 (normal) to 4 (the most abnormal), providing a daily score of 0 to 24 points. MOF is defined as 2 or more points in at least two organ systems. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - other clinical outcome parameters - frequency of treatment failure - time until reversal of coagulopathy - transfusion requirements - ROTEM® and biological parameters ;Timepoint(s) of evaluation of this end point: - Visit 0 (t0/day 0) - Visit 7 (day 30) - Visit 0 (t0/day 0) - end of treatment period - Visit 0 (t0/day 0) - time until reversal of coagulopathy - Visit 0 (t0/day 0) - Visit 7 (day 30) - Visit 0 (t0/day 0) - Visit 5 (48 h) | — |
Countries
Austria
Contacts
Public ContactStudienkoordination
Medizinische Universtität Innsbruck / UK für Anästhesie und Intensivmedizin
Outcome results
None listed