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)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 67
- 试验地点
- 16
- 主要终点
- Change of the Fibrinogen polymerisation measured with FIBTEM® MCF
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trauma patient
- •Patient at the obvious age of equal or higher than 18 years of either sex
- •Major bleeding or occult bleeding with parameters of shock
- •Need for volume replacement therapy
- •Patient, who will be admitted to one of the participating hospitals
排除标准
- •Solely penetrating trauma
- •Solely head injury
- •In case of ongoing severe hemodynamic instability refractory to therapy (vasopressor, volume)
- •Patient with inevitable lethal course as evaluated by emergency physician
- •Need for CPR on the scene
- •Deep hypothermia (below 30°C)
- •Obviously pregnant women
- •Patient with known recent history of thromboembolic events within the last 6 months
- •Patient known to be on anticoagulant therapy
- •Patient with known refusal of a participation in this clinical trial
研究组 & 干预措施
Human Fibrinogen Concentrate
Fibrinogen Concentrate will be 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: 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).
干预措施: Human Fibrinogen Concentrate (Drug)
Placebo
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)
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).
干预措施: Placebo (Drug)
结局指标
主要结局
Change of the Fibrinogen polymerisation measured with FIBTEM® MCF
时间窗: 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).
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).
次要结局
未报告次要终点
研究者
Dietmar Fries, M.D.
Coordinating and Principal Investigator
Medical University Innsbruck