Pilot Study 01 :: FI IN TIC

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A multicenter double-blind, placebo controlled, randomized, pilot trial      
to assess the efficacy of pre-hospital administration of Fibrinogen Concentrate (FGTW) in trauma patients, presumed to bleed.

This study will evaluate 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.
Change from baseline (before FGTW administration) to hospital admission (T2) in MCF FibtEM® (Maximum Clot Firmness) – as the measure of fibrinogen polymerisation capacity. Primary Objective To assess improvement in plasmatic coagulation capacity Primary Endpoint Fibrinogen polymerisation measure with the FIBTEM® MCF

Study Start: August 2011
End of study (anticipated): November 2014

Number of Patients 60 (2x30) evaluable patients
Duration of Patient Participation 30 days
Investigational Medicinal Product Human Fibrinogen Concentrate (FGTW), LFB Biomedicaments, France

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 MAIN 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

Severe traumatized patients with visible significant bleeding and/or with clinical signs of internal significant bleeding treated by an emergency doctor of the helicopter service or the ground team will be enrolled in the study. The baseline values on the scene (T1) will first be collected including the first blood sample as well as documentation of the clinical parameters. Subsequently, 30 patients will be randomized to receive about 50 mg/kg BW fibrinogen concentrate (one vial for each 30 kg body weight, estimated by the emergency physician), while the other 30 patients receive placebo (also one vial including 100 ml for each 30 kg body weight). Immediately after admission to hospital, the patient's parameters including blood sample will be measured for the second time (T2). Additional measurements will be made 3 hours (T3), 9 hours (T4), 24 hours (T5), 48 hours (T6) and one week after admission (T7). 30 days after inclusion in the study, a final investigation is planned (T8). Coagulation management after admission to hospital is depending on the specific demands of the patient and should be performed according to the recommendations of the Austrian Society for Anaesthesiology, Intensive Care Medicine and Resuscitation (ÖGARI) >>) and the European Guidelines of Critical Care >>). Blood loss, transfusion requirements, volume therapy and coagulation therapy will be documented. When the bleeding is under control thromboprophylaxis has to be performed according to the international standard of care earliest after 24 hours after cessation of bleeding (preferably using enoxaparin).

Medical University Innsbruck Department of General and Surgical Intensive Care Medicine

ao Univ.-Prof. Dr. Dietmar Fries

A01 - Medical University Innsbruck Department of General and Surgical Intensive Care Medicine PI: Univ.-Prof. Dr. Dietmar Fries
A02 - AUVA Trauma Center / Emergency Hospital Salzburg Department for Anesthesia and Intensive Care Medicine PI: OA Dr. Herbert Schöchl
A03 - University Hospital Salzburg (PMU) / Regional Hospital Salzburg Department for Anesthesia and Intensive Care Medicine PI: Dr. Bernhard Ziegler
A04 - Regional Hospital Vöcklabruck Clinical Department for Anesthesia and Intensive Care Medicine PI: Prim. Mag. Dr. Günther Sumann
C01 - University Hospital Hradec Kralove (planned) Department for Anaesthesiology and Intensive Care PI: Dr. Anatolij Truhlar
D01 - Aarhus University Hospital (planned) Department of Anaesthesiology PI: Dr. Christian Fenger-Eriksen Emergency Bases H01 - Christophorus 1 Helicopter Base PI: Dr. Marc Kaufmann
H02 - Christophorus 4 Helicopter Base PI: Prim. Mag. Dr. Günther Sumann
H03 - Christophorus 6 Helicopter Base PI: Dr. Bernhard Ziegler
H06 - Christophorus 14 Helicopter Base PI: Dr. Christine Haas
H07 - Martin 2 Helicopter Base PI: Dr. Christian Niederwanger
H08 - NEF Innsbruck PI: Univ. Doz. Dr. Michael Baubin
H09 - NEF Salzburg Stadt PI: Dr. Bernhard Ziegler
H11 - NAW Vöcklabruck PI: Prim. Mag. Dr. Günther Sumann
H12 - Christophorus 5 Helicopter Base (planned) PI: Dr. Manuel Mauerer
H13 - NEF Telfs (planned) PI: Dr. Markus Thaler
K01 - Christoph 06 Helicopter Base (planned) PI: Dr. Anatolij Truhlar
N01 – Akutlægehelikopter Karup Lufthavn (planned) PI: Dr. Christian Fenger-Eriksen
N02 - Akutlægebilen i Aarhus Anæstesiologisk Afdeling / Aarhus Universitetshospital (planned) PI: Dr. Christian Fenger-Eriksen

DOWNLOAD the excel file below and print it for every patient included. This is a tool to help calculating and maintaining the timepoints of study specific blood withdrawal for study patients.
1.    download the excel file
2.    fill out all fields marked yellow
(Patient Number, Patient Name, Inclusion Time and Date)
3.    study specific timepoints of taking blood samples will be calculated automatically
4.    if possible fill out the timepoint of taking the blood sample on the site of the accident (green fields)
5.    print the excel file
6.    put on adhesive patient label
(if possible)
7.    leave the printout with the patient (e.g. inside the patient file)
8.    when taking study specific blood samples fill out the respective white field (realized at…)