Cryo-FIRST: Cryoprecipitate For Immediate Resuscitation in Severe Trauma: Effectiveness of Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) for Treatment of Trauma Associated Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 320
- 试验地点
- 8
- 主要终点
- Correction of functional fibrinogen
研究概览
简要总结
The objective of this multicenter, single-arm, observational study is to determine the feasibility and effectiveness of early administration of FDA-approved, pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) in trauma patients with hemorrhagic shock (HS) and functional hypofibrinogenemia. This study will determine whether rapid point-of-care testing for functional hypofibrinogenemia and availability of a shelf-stable fibrinogen complex (IFC) results in shorter time to administration of fibrinogen replacement and correction of functional hypofibrinogenemia, as compared with historical controls and published literature using conventional cryoprecipitate-AHF (CRYO-AHF).
This study aims to:
- Demonstrate the feasibility and response to early administration of pre-thawed IFC when ordered during initial resuscitation of severely injured patients with HS and functional hypofibrinogenemia.
- Assess the effectiveness of early administration of pre-thawed IFC on correction of functional hypofibrinogenemia and on proximate process measures of resuscitation, including time to hemostasis, time to completion of resuscitation, and total volume of resuscitation.
- Assess clinical outcomes in severely injured patients with HS and functional hypofibrinogenemia receiving early administration of pre-thawed IFC.
详细描述
This is a multicenter, pragmatic, observational, single-arm study evaluating the feasibility and effectiveness of early administration of pre-thawed Pathogen Reduced Cryoprecipitated Fibrinogen Complex (INTERCEPT Fibrinogen Complex, IFC) in trauma patients with hemorrhagic shock and functional hypofibrinogenemia.
Adult trauma patients age ≥18 years, or estimated weight ≥50 kg if age is unknown, who present to a participating trauma center within 1 hour of estimated time of injury and meet criteria for hemorrhagic shock will be screened using the point-of-care Quantra® Hemostasis Analyzer. Functional hypofibrinogenemia is defined as FCS <1.6 hPa by Quantra® point-of-care testing. Patients are eligible only if cryoprecipitate administration is clinically indicated by the treating physician, IFC is available at the time of enrollment, and the patient will receive IFC per standard of care.
Following administration of IFC, an additional Quantra® point-of-care test will be completed at completion of resuscitation (COR), defined as discontinuation of the massive transfusion protocol (MTP), to evaluate fibrinogen response. Additional IFC may be administered if additional hemostatic correction is determined to be needed by the treating clinician, repeat point-of-care testing, or clinical judgment.
Primary outcomes are the proportion of patients with hemorrhagic shock and functional hypofibrinogenemia who receive IFC within 60 minutes of presentation to the participating trauma center and the proportion of patients with successful correction of functional hypofibrinogenemia at COR. Secondary outcomes include time to hemostasis, estimated blood loss, transfusion burden/total volume of resuscitation, mortality at 3 hours, 6 hours, 24 hours, and 30 days or in-hospital mortality, and adverse clinical outcomes through 30 days, hospital discharge, or death, whichever occurs first. Outcomes may be compared descriptively with historical controls, site medical databases, and published literature using CRYO-AHF.
Four Level 1 trauma centers will enroll approximately 320 patients over approximately 24 months.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Traumatic injury
- •Age ≥18 years or estimated weight ≥50 kg, if age unknown
- •Presenting to a participating trauma center ≤1 hour from estimated time of injury
- •Functional hypofibrinogenemia upon arrival to the trauma center as measured by point-of-care testing (Quantra®) with FCS <1.6 hPa
- •Hemorrhagic shock, defined as:
- •Initiation of transfusion of any uncrossmatched blood product;
- •Evidence of active hemorrhage as judged by the attending trauma surgeon; and
- •Initiation of the participating trauma center's massive transfusion protocol (MTP)
- •IFC administration is clinically indicated per the treating physician
- •IFC is available at the time of enrollment
排除标准
- •Suspected isolated severe brain or spinal cord injury
- •Isolated drowning or hanging
- •Burns >20% total body surface area (TBSA)
- •Known pregnancy
- •Admitted from a correctional facility
- •Known do not resuscitate (DNR) order
- •Traumatic arrest >5 minutes, defined as continuous CPR >5 minutes at any time point prior to enrollment in the study
- •Isolated fall from standing
- •Emergency Department (ED) thoracotomy
研究组 & 干预措施
IFC arm
Subjects will receive Pathogen Reduced Cryoprecipitated Fibrinogen Complex (IFC) for fibrinogen supplementation.
干预措施: Pathogen Reduced Cryoprecipitated Fibrinogen Complex (Biological)
结局指标
主要结局
Correction of functional fibrinogen
时间窗: From time of initiation of anesthesia until time of completion of resuscitation.
The correction of functional fibrinogen as measured by point-of-care testing (Quantra) after transfusion of IFC or CRYO-AHF, as measured at completion of resuscitation. The time to correction of functional fibrinogen is reported in hours and minutes.
The proportion (%) of patients who receive IFC or Cryo-AHF within 60 minutes of presentation to the participating trauma center.
时间窗: From time of admission to the hospital trauma service to initial transfusion of either IFC or Cryo-AHF, measured in hours and minutes.
The proportion (%) of patients with hemorrhagic shock who have functional hypofibrinogenemia and who receive IFC or Cryo-AHF within 60 minutes of presentation to the participating trauma center.
次要结局
- Mortality rates(Measured from the time of admission to the hospital trauma service until death. Measured at 3, 6, and 24 hours after admission and reported in hours. Beyond 24 hours and up to 30 days post-admission, mortality is measured and reported in days.)
- Clinical complications(Within 24 hours of treatment.)