Fibrinogen Concentrate (FGTW) in Trauma Patients, Presumed to Bleed (FI in TIC)

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01475344
• Other study ID #: FIinTIC
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 27, 2011
• Last updated: December 7, 2015
• Start date: September 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Trauma patient

2. Patient at the obvious age of equal or higher than 18 years of either sex

3. Major bleeding or occult bleeding with parameters of shock

4. Need for volume replacement therapy

5. Patient, who will be admitted to one of the participating hospitals

Exclusion Criteria:

1. Solely penetrating trauma

2. Solely head injury

3. In case of ongoing severe hemodynamic instability refractory to therapy (vasopressor, volume)

4. Patient with inevitable lethal course as evaluated by emergency physician

5. Need for CPR on the scene

6. Deep hypothermia (below 30°C)

7. Obviously pregnant women

8. Patient with known recent history of thromboembolic events within the last 6 months

9. Patient known to be on anticoagulant therapy

10. Patient with known refusal of a participation in this clinical trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Massive Hemorrhage
• Trauma
• Wounds and Injuries

Intervention

Drug:
• Human Fibrinogen Concentrate
intravenous infusion 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 Concentrate: 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).
• Placebo
intravenous infusion 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) Placebo: 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).

Locations

Country	Name	City	State
Austria	Christophorus 1	Innsbruck
Austria	Medical University Innsbruck	Innsbruck
Austria	Martin 2	Karres
Austria	Christophorus 14	Niederöblarn
Austria	AUVA Trauma Center	Salzburg
Austria	Christophorus 6	Salzburg
Austria	Alpin 2	Sölden
Austria	NEF Telfs	Telfs
Austria	NAW Vöcklabruck	Vöcklabruck
Austria	Regional Hospital Vöcklabruck	Vöcklabruck
Austria	Christophorus 5	Zams
Czech Republic	Ambulace Car	Liberec
Czech Republic	Hospital Liberec	Liberec
Czech Republic	Krystof 18 Helicopter Base	Liberec
Germany	Christoph 3	Cologne
Germany	Cologne-Merheim Medical Center	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Countries where clinical trial is conducted

Austria,  Czech Republic,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of the Fibrinogen polymerisation measured with FIBTEM® MCF	Further measurements and investigations will be done until 7 days after the hospital admission. The patient will be followed up until 30 days (final interview).	The average period for the measurement (MCF) of the primary outcome is 60 minutes . Timepoints of measurements: Emergency scene (minute 0) and arrival to the hospital (on average after 60 minutes).	No