Point of Care Fibrinogen Measurement in Trauma Patients in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Feasibility of qLabs Fib testing in the emergency department
研究概览
简要总结
Background: Why This Study Matters When someone suffers a severe injury (like from a car crash), they can bleed heavily. One complication doctors often face is something called Trauma-Induced Coagulopathy (TIC). This is a condition where the blood doesn't clot properly, making bleeding worse. The reasons behind TIC are complicated and not fully understood.
One important substance involved is fibrinogen, a protein that helps blood clot. Low levels of fibrinogen are often the first sign of TIC and tend to be linked with how bad the injury is. Because of this, doctors have been giving trauma patients extra fibrinogen early on, hoping it will help them survive.
However, a recent large study (called CRYOSTAT-2) showed that giving high doses of fibrinogen to all trauma patients didn't actually help reduce deaths. This suggests that not everyone needs it-only patients with very low fibrinogen levels (below 1.5 grams per liter) should get it.
The problem is: it currently takes 30 to 45 minutes to get fibrinogen test results. In emergency situations, that's too slow. So doctors have been guessing who needs it, which might not always be the best approach.
What This Study Aims to Do This new study wants to see if a faster, bedside test-called a point-of-care (POC) fibrinogen test-can be used in the Emergency Department (ED) during trauma resuscitations.
Main Goals:
Feasibility: Can the test be done quickly and easily during emergency care?
Usefulness: If the fast test had been available, would doctors have made different decisions-like giving or not giving fibrinogen? And would that have changed outcomes for the patients?
Study Details Feasibility Study: To see if the test is practical during trauma care.
Retrospective Cohort Study: To look back at patients and see if early test results could have changed decisions or outcomes.
Who's In the Study? Adults over 16 who arrive at the ED with serious trauma and for whom the hospital's Massive Transfusion Protocol was activated (meaning they had major bleeding).
They must have received at least one unit of blood.
How the Study Will Work The Test: A small amount of blood (0.15 ml) will be taken from blood that's already being drawn for routine care-so no extra blood draws are needed.
The POC test (called qLabs Fib) will be done at the same time as standard lab tests.
Important Note: Doctors won't make decisions based on this fast test for now. It's just being tested for feasibility.
Nurses will note how long the test takes and if they had any trouble using it.
Later, researchers will look back at the data to see:
- What the fibrinogen levels were.
- Whether the fast results could have helped guide better treatment.
- If outcomes like how much blood was given or survival were affected.
Why It Matters If the fast test works well, it could lead to
- Faster, more accurate treatment in trauma cases.
- Less unnecessary use of fibrinogen, saving resources and avoiding possible side effects.
- Better outcomes for patients by tailoring treatment to their actual needs.
详细描述
Rationale:
Worldwide, trauma accounts for 5.8 million deaths every year and trauma is the leading cause of death under the age of 44. Up to 25% of trauma victims have clotting abnormalities known as trauma induced coagulopathy (TIC). TIC is a complex, multifactorial coagulation disorder of which the exact pathophysiology is not completely understood. Patients with TIC have a three- to four-fold increased risk of death. While many factors have been identified to influence TIC, fibrinogen is thought to be one of the central players. A low level of fibrinogen is one of the first signs of TIC and there is a strong relation between fibrinogen levels and injury severity.
Measuring fibrinogen levels in the clinical laboratory takes a long time (30-45min), therefore fibrinogen suppletion in acute massive hemorrhage is usually empirical. Several observational studies showed clinical benefit from fibrinogen suppletion in trauma. However, the CRYOSTAT-2 trial, a multi-center randomized controlled trial, did not find a mortality benefit for empirical treatment with high dose fibrinogen.
Trauma patients presented at the emergency department (ED) are currently treated using an integrated approach commonly known as damage control resuscitation. The focus of treatment is 1. Identify and stop ongoing bleeding, and 2. Hemostatic resuscitation consisting of supplementing the blood loss by red blood cell, plasma, and platelet transfusion in prespecified ratios. Coagulation correction by administration of tranexamic acid, calcium and fibrinogen is often included in massive transfusion protocols. As soon as laboratory results become available, the empirical treatment transfers into goal directed treatment based on the lab results. Until now it has been impossible to use a goal directed approach for coagulation correcting in the first hour after arrival in the ED because results from coagulation tests take 30-45min to become available.
In summary, fibrinogen plays an important role in TIC and a low fibrinogen is related to worse outcomes, however, empirical treatment with fibrinogen in the trauma patient suspected of massive hemorrhage does not lead to improved outcomes. A goal directed approach based on real time fibrinogen measurements would therefore be preferred.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Population (base) Adult trauma patients will be identified as follows: (1) by the trauma team leader on admission to the ED or (2) by the research team personnel following a massive transfusion protocol activation. Patients will be assessed for eligibility to enter the trial according to the criteria set out below. If patients are eligible for entry into the study following initial screening, they will be enrolled automatically under deferred consent. Patients will be considered eligible for enrolment in this trial if they fulfil all the inclusion criteria and none of the
排除标准
- •detailed below.
- •Inclusion criteria
- •To be eligible to participate in this study, a subject must meet the following criteria:
- •The participant is judged to be an adult (according to the attending clinician, e.g. 16 years or older) and has sustained traumatic injury
- •The participant is deemed by the attending clinician to have on-going active hemorrhage
- •The major hemorrhage protocol (MTP) is activated or this patient and transfusion is initiated
- •Exclusion criteria
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •The participant has been transferred from another hospital
- •The trauma team leader deems the injuries incompatible with life
研究组 & 干预措施
Trauma patients for which the massive transfusion protocol is activated and transfusion is initiated
结局指标
主要结局
Feasibility of qLabs Fib testing in the emergency department
时间窗: 2 hours after inclusion
Feasibility of qLabs Fib testing in the ED, where feasibility will be determined by percentage of qLabs Fib results available within 30min after patient arrival in the ED.
次要结局
- Incidents during testing(2 hours after inclusion)
- Total number of transfusion products uses(24 hours)
- 6hr, 24hr and 30d mortality(30 days)
- Coagulation measurements in the first 24hrs(24 hours)
- Trauma mechanism(2 hours after inclusion)
- Injury severity score(2 hours after inclusion)
- Blood pressure on ED presentation(2 hours after inclusion)
- Pulse on ED presentation(2 hours after inclusion)
- Respiratory rate on ED presentation(2 hours after inclusion)
研究者
Niki Ottenhof
Dr.
Erasmus Medical Center