A Pilot Randomized Clinical Trial of the XSTAT Hemostatic Device in the Prehospital Setting
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Incidence of Patients With Hemorrhage From Junctional Wounds
研究概览
简要总结
This study evaluates the prehospital use of the XSTAT device to control bleeding in junctional wounds. Participants will be randomized to the use of XSTAT versus standard care.
详细描述
The XSTAT® device injects small, rapidly-expanding cellulose sponges into the wound cavity using a syringe-like delivery system. In the wound, XSTAT® sponges expand and swell to fill the wound cavity, within 20 seconds of contact with blood, facilitating compression of bleeding structures. XSTAT® can be applied through skin wounds. The system can readily access deep vascular structures. While rapidly hemostatic, the hemostatic sponges are also relatively easy to remove. In the setting of junctional bleeding, XSTAT® may allow for hemostatic pressure generation from within the wound tract rather than from external compression (as with a tourniquet or manual compression).
Hemorrhage should be controlled as early as possible, ideally before reaching a trauma center or medical treatment facility. Given its small size, low weight, and ease of application, the XSTAT® device is well-suited for prehospital use, in both the civilian and military setting, and this is probably where the device's applicability lies.
The investigators anticipate that a full-scale trial will be conducted based on the questions this pilot study addresses, including the following:
- the number of penetrating junctional zone injuries encountered in the prehospital civilian setting.
- the feasibility of randomizing patients in the prehospital setting.
- usability.
- safety.
- validation of the proposed primary outcome of an efficacy trial.
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
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥15 years or estimated body weight ≥50 kg.
- •Penetrating junctional injury (femoral or axillary), with i. visible bleeding ii. too proximal to be controlled with a tourniquet
- •Patient will be taken to participating level I trauma center, directly from the scene
排除标准
- •Prisoners, children <15 years old, known pregnant patients.
- •Patients receiving chest compressions (prior to XSTAT® use).
- •Patients with an opt-out bracelet.
研究组 & 干预措施
Treatment with XSTAT
Participants randomized to the treatment arm will be treated using the study device - XSTAT.
干预措施: XSTAT (Device)
Standard Care
Participants assigned to the control group receive standard prehospital care, consisting of direct pressure/dressings.
干预措施: Standard of Care (Other)
结局指标
主要结局
Incidence of Patients With Hemorrhage From Junctional Wounds
时间窗: Each participant was assessed at the time of arrival in hospital
The investigators will track the number of junctional wounds that are treated by participating EMS personnel versus the number of participants who were enrolled in this study. This will help the investigators understand how many wounds of this type happen, and how many would possibly benefit from the use of the XSTAT device.
Record Blood Lactate Level Result
时间窗: Baseline - on admission
Record results of routine test
Base Deficit (mmol/l)
时间窗: Baseline - on admission
Base excess and base deficit refer to an excess or deficit, respectively, in the amount of base present in the blood. The value is usually reported as a concentration in units of mEq/L (mmol/L), with positive numbers indicating an excess of base and negative a deficit. A typical reference range for base excess is -2 to +2 mEq/L. It is a test performed on a blood sample, venous or arterial. In trauma patients, a metabolic acidosis is indicative of the degree of shock, causing hypoperfusion. A more negative value indicates more severe acidosis, and more severe shock.
Record Hemoglobin/Hematocrit Result
时间窗: Baseline - on admission
Record results of routine test
Record Platelet Count Result
时间窗: Baseline - on admission
Record results of routine test
Record Prothrombin Time Result
时间窗: Baseline - on admission
Record results of routine test
Record International Normalized Ratio (INR) Result
时间窗: Baseline - on admission
Record results of routine test
Record Activated Partial Thromboplastin Time (APTT) / Ratio Result
时间窗: Baseline - on admission
Record results of routine test
Record Thromboelastograph (TEG) Result if Available
时间窗: Baseline - on admission
Record results of routine test
Record Thromboelastogram (ROTEM) Result if Available
时间窗: Baseline - on admission
Record results of routine test
Ease of Use of XSTAT Device by EMS Personnel
时间窗: From baseline to 29 months (enrollment phase)
To answer the question "Is the XSTAT device easy to use in the prehospital setting," the study case report forms capture whether EMS personnel found the device easy to insert into a wound, whether the sponges were expelled from the device easily, and whether the EMS personnel were satisfied or dissatisfied with the XSTAT device itself.
Sponge Removal: Surgeon Opinion of Ease of Removal, Time Required to Remove Sponges, Use of X-rays, Whether Surgeon Was Satisfied or Dissatisfied With the XSTAT Device.
时间窗: From baseline to 29 months (enrollment phase)
Case report forms capture whether sponges were easy to remove, how much time was required to remove the sponges, whether x-rays were obtained to ensure that no sponges were left in the body, and whether the surgeon was satisfied or dissatisfied with the XSTAT device
Adverse Events From Use of XSTAT Device
时间窗: Randomization through first 7 days, unless discharged earlier
All AEs, whether expected or unexpected will be recorded and reviewed throughout the trial. Each AE will be reported separately, with a description of the event, whether it was related to the device, whether it was serious, and whether it was expected or unexpected.
Survival at 30 Days
时间窗: Hospital admission through 30 days
Time of death, or survival at 30 days will be recorded
次要结局
未报告次要终点
研究者
Jan O. Jansen
Primary Investigator
University of Alabama at Birmingham