Early Administration of Fibrinogen Concentrate in Polytraumatized Patients With Thromboelastometry Suggestive of Hypofibrinogenemia: a Randomized Feasibility Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization
研究概览
简要总结
This is a randomized feasibility trial conducted with severe trauma patients. At admission patients presented hypofibrinogenemia, hypotension and tachycardia. The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization. The treatments regards to receive or not to receive an early replacement of fibrinogen.
详细描述
This is a randomized feasibility trial conducted between December 2015 and January 2017 with severe trauma patients (Index of Shock Severity [ISS] ≥ 15) admitted to the emergency room of a large trauma center. At admission patients presented qualitative hypofibrinogenemia (FIBTEM A5 ≤ 9 mm), hypotension (systolic blood pressure <90 mmHg) and tachycardia (heart rate > 100 bpm). The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization meaning receive replacement through fibrinogen concentrate (50mg per kg of body weight) by the intervention group and not to receive an early replacement of fibrinogen by control group.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •Severe trauma patients (Index of Shock Severity [ISS] ≥ 15)
- •Hypotension (systolic blood pressure < 90 mmHg)
- •Tachycardia (heart rate > 100 bpm)
- •Qualitative hypofibrinogenemia (FIBTEM A5 ≤ 9 mm)
排除标准
- •Patient or family do not agree to sign the informed consent form
- •Eligible for institutional massive transfusion protocol
- •Previous coagulopathy disorders
- •Use of anticoagulants drugs and/or platelet anti aggregation drugs (exception for aspirin)
- •Previous thromboembolic disorders or events
- •Cardiopulmonary arrest before hospital admission
- •Patient admitted after another hospital transfer
- •Time from trauma to screening above six hours
- •Patients with exclusively traumatic brain injury
研究组 & 干预措施
Intervention
Receive early replacement through fibrinogen concentrate (50mg per kg of body weight)
干预措施: Fibrinogen concentrate (Drug)
结局指标
主要结局
Feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization
时间窗: 60 minutes
The proportion of patients receiving the allocated treatment up to 60 minutes after randomization
次要结局
- Costs of blood therapy assessed by de median value spent on each patient due to red blood cell, fresh frozen plasma, blood platelets, cryoprecipitate and fibrinogen concentrate(Up to four weeks - Through the Length of operating room stay)
- Overall blood tube drainage(Up to four weeks - Through the length of hospital stay)
- Length of hospital stay(Up to four weeks - Through the Length of operating room stay)
- Sequential Organ Failure Assessment (SOFA) score on the first day after intensive care unit admission(First day after intensive care unit admission)
- Sequential Organ Failure Assessment (SOFA) score on the fifth day after intensive care unit admission(Fifth day after intensive care unit admission)
- Sequential Organ Failure Assessment (SOFA) score on the seventh day after intensive care unit admission(Seventh day after intensive care unit admission)
- Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate(Up to four weeks - Through the Length of operating room stay)
- Thromboembolic events assessed by any clinical manifestation that can be related to a thromboembolic event(First two weeks after hospital admission)
- Length of intensive care unit stay(Up to four weeks - Through the Length of intensive care unit stay)
- In-hospital Deaths(Up to four weeks - Through the Length of operating room stay)
- Reoperate due to bleeding(Up to four weeks - Through the Length of operating room stay)
- Ventilator-free days(Up to four weeks - Through the Length of operating room stay)
- Vasopressor-free days(Up to four weeks - Through the Length of operating room stay)
研究者
Lucas Siqueira de Lucema
Lucas Lucena
University of Sao Paulo General Hospital