跳至主要内容
临床试验/NCT04726410
NCT04726410已完成2 期

Cold Stored Platelet Early Intervention in Traumatic Brain Injury Trial

Jason Sperry1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年3月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Jason Sperry
入组人数
100
试验地点
1
主要终点
Study Feasibility

研究概览

简要总结

The Cold Stored Platelet Early Intervention in Traumatic Brain Injury (CriSP-TBI) trial is a proposed 3 year, open label, single center, randomized trial designed to determine the feasibility, efficacy, and safety of urgent release cold stored platelets (CSP) in patients with TBI requiring platelet transfusion. Patients will be randomized to receive either standard care or early infusion of urgent release cold stored platelets (CSP). The proposed pilot study will enroll at the University of Pittsburgh and will enroll approximately 100 patients. The primary outcome for the pilot trial is feasibility, with principal secondary clinical outcome of 6-month Extended Glasgow Outcome Scale (GOS-E).

详细描述

Platelet transfusion is commonly provided to patients with moderate or severe TBI who are on antiplatelet medications. Evidence suggests that patients on antiplatelet medications may have worse outcomes following TBI. Current literature has not demonstrated major outcome improvements in those patients who receive platelet transfusion. This lack of significant benefit may be due to insufficient dosing or due to the poor hemostatic function of standard care room temperature platelets. Studying the potential benefits of Cold Stored Platelet transfusion in the TBI population will provide needed direct comparison of room temperature and cold stored platelet transfusion which is unable to occur in patients with hemorrhagic shock, who may require large volumes of red blood cells and plasma concomitantly with platelet transfusion.

By providing Cold Stored Platelets in an urgent release fashion following injury, a potentially superior hemostatic agent is given early, closer to the time of injury. The current pilot trial was designed to determine the feasibility, efficacy and safety of urgent release cold stored platelets as compared to standard care in TBI patients requiring platelet transfusion. There are no high-level data which appropriately characterize the urgent release use of cold stored platelets out to 14 days or their function over that time period as compared to standard room temperature platelets. These results will be able to inform future large randomized clinical trials allowing the most appropriate injured population, inclusion criteria, and primary outcome to be selected and utilized.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with traumatic brain injury, defined by presence of potential progressive intracranial injury on CT scan, at significant risk for urgent neurosurgical procedure as determined by neurosurgical evaluation, who meet at least one of the following:
  • History or indication of pre-injury antiplatelet agent use
  • Need for platelet transfusion per standard practice

排除标准

  • Wearing NO CriSP opt out bracelet
  • Hypotension in Emergency Department (SBP< 90 mmHg)
  • Age > 89 or < 18 years of age
  • Penetrating injury
  • Going to operating room for non-neurosurgical intervention in first 60 minutes
  • Platelet transfusion contraindications per care team (for example, recent vascular stent, embolic stroke, intracranial and/or vascular lesions)
  • Objection to study voiced by participant or family member in Emergency Department
  • Currently on therapeutic anticoagulant in addition to aspirin and/or clopidogrel (e.g. warfarin, direct-acting oral anticoagulants)

研究组 & 干预措施

Cold-stored Platelet (CSP)

Experimental

early infusion of up to 2 units of urgent release cold stored platelets (CSP)

干预措施: Cold Stored Platelets (Biological)

Standard care

Active Comparator

standard care therapy

干预措施: Standard Care (Biological)

结局指标

主要结局

Study Feasibility

时间窗: 6 months

proportion of eligible patients that can be randomized, enrolled, adhere to protocol, and complete follow-up

次要结局

  • 24-hour Mortality(Enrollment through 24 hours)
  • In-hospital Mortality(Enrollment through discharge up to 6 months)
  • Incidence of Allergic/Transfusion Reaction(Enrollment through 24 hours)
  • 6-month Extended Glasgow Outcome Scale (GOS-E)(6 months after enrollment)
  • TBI Progression(Enrollment through 24 hours)
  • Galveston Orientation and Amnesia Test (GOAT)(At Discharge from Current Hospital Admission)
  • Incidence of Transfusion Related Acute Lung Injury (TRALI)(Enrollment through 48 hours)
  • Incidence of Thromboembolic Events(Enrollment through 48 hours)

研究者

发起方
Jason Sperry
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jason Sperry

Professor of Surgery and Critical Care Medicine

University of Pittsburgh

研究点 (1)

Loading locations...

相似试验