Trauma Clinical Trial
Official title:
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 (FI in TIC)
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 (inclusion- and exclusion criteria: see
above). If a patient meets the inclusion criteria and is recruited for the study, FGTW or
placebo administrated over 5 min/vial:
Body Weight: < 30 kg / 30-60 kg / 60 - 90 kg / > 90 kg
No. of vials: 1 vial (100 ml) / 2 vials (200 ml) / 3 vials (300 ml) / 4 vials (400 ml)
Fibrinogen (if applicable): 1.5 g / 3 g / 4.5 g / 6 g
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 (inclusion- and exclusion criteria: see
above). If a patient meets the inclusion criteria and is recruited for the study, his
baseline values on the scene (T1) will first be collected including the first blood
collection as well as documentation of the clinical parameters (hemodynamics, respiratory
and neurological function, etc.). 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). The flow rate should not exceed 100 ml within
5 minutes.
FGTW or placebo administrated over 5 min/vial:
Body Weight: < 30 kg / 30-60 kg / 60 - 90 kg / > 90 kg
No. of vials: 1 vial (100 ml) / 2 vials (200 ml) / 3 vials (300 ml) / 4 vials (400 ml)
Fibrinogen (if applicable): 1.5 g / 3 g / 4.5 g / 6 g
Immediately after admission to hospital, the patient's parameters including blood collection
(see below) will be measured for the second time (T2), if applicable, after the end of
administration of the study drug. Additional measurements will be made 3 hours (T3), 9 hours
(T4), and 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)
(http://www.oegari.at/web_files/dateiarchiv/116/key%20messages%20management%20of%20TIC%202011.pdf). 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).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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