Effect of Remote Ischemic Conditioning on Neutrophil Function and the Immune-Inflammatory and Coagulation Profiles in Trauma Patients With Hemorrhagic Shock

Unity Health Toronto2 个研究点分布在 1 个国家目标入组 50 人开始时间: 2015年5月最近更新: 2023年6月7日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Unity Health Toronto
入组人数: 50
试验地点: 2
主要终点: Neutrophil Oxidative Burst Activity

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to evaluate whether remote ischemic conditioning is a safe and effective intervention to prevent the development of inflammation and coagulopathy in trauma patients with hemorrhagic shock.

详细描述

Dysfunction of vital organs is one of the major reasons why trauma victims die after sustaining a major injury, even though the organs themselves may not have been directly injured. The inability to clot blood as a result of inflammation further contributes to complications in a majority of these patients. One intervention proposed to protect against impaired organ function is called "Remote Ischemic Conditioning", wherein application of intermittent occlusion and release of blood flow to the arm by sequentially inflating and deflating a blood pressure cuff can protect against the development of distant organ injury and inflammation following a severe traumatic event. In a pilot study, we will investigate the effects of remote ischemic conditioning in trauma patients with hemorrhagic shock, with a view to evaluate its effects on the immune system and coagulation profiles, both of which are known to be deranged in these patients. These studies will potentially benefit patients and will serve as a proof of principle for the use of remote ischemic conditioning in the trauma setting.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Supportive Care
盲法: Triple (Participant, Investigator, Outcomes Assessor)

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

•Age ≥16 years of age or estimated weight ≥50kgs if age is unknown;
•Victim of blunt or penetrating trauma
•Hemorrhagic shock defined as:
•One or more episodes of systolic blood pressure ≤90mmHg at any time prior to enrollment into the study;
•An identified source of blood loss (abdomen, chest, pelvis/retroperitoneum, extremities, external) or
•Blood products (RBC, Platelets, Plasma, etc.) has been ordered to the trauma room.
•Admitted to St. Michael's Hospital directly from the scene of injury within 3 hours of the injury
•Application and completion of Remote Ischemic Conditioning (RIC) within 4 hours of the injury

排除标准

•Pregnancy
•Non-hemorrhagic shock (i.e. tension pneumothorax, cardiac tamponade, spinal shock, etc.)
•Major burns > 20% total body surface area
•Fracture of both lower extremities (i.e. traumatic amputation, fractures)
•Absence of vital signs prior to admission, ongoing CPR, possibly dead on admission or not expected to survive beyond a few hours.
•Injury in both legs (traumatic amputation, fractures, etc.)
•Patients with a systolic blood pressure above 200mmHg
•Patients treated with anticoagulants, antiplatelet therapy (Warfarin, Aspirin), steroids or with a known bleeding disorder or known abnormality of blood flow to the limb (if known)
•Patients with osteoporosis or other bone disorders, peripheral nerve injury, abnormal nerve supply, peripheral neuropathy (if known) or preexisting traumatic injury to the limb.
•Morbid obesity (largest cuff size won't fit)
•If RIC is done clinically before research protocol begins.

结局指标

主要结局

Neutrophil Oxidative Burst Activity

时间窗: 0 (Admission), 1, 3, and 24 hours after intervention

Change in neutrophil oxidative burst activity (dihydrorhodamine, DHR) over 24 hours from admission. Measured by flow cytometry using whole blood samples.

Neutrophil Oxidative Burst Activity (PMA Stimulated)

时间窗: 0 (Admission), 1, 3, and 24 hours after intervention

Change in PMA stimulated neutrophil oxidative burst activity (dihydrorhodamine, DHR) over 24 hours. Measured by flow cytometry using whole blood samples.

Neutrophil Adhesion Molecule Expression (CD11b)

时间窗: 0 (Admission), 1, 3, 24 hours after intervention

Change in neutrophil adhesion molecule (CD11b) expression over 24 hours from admission. Measured by flow cytometry using whole blood samples.

Neutrophil Adhesion Molecule Expression (CD62L)

时间窗: 0 (Admission), 1, 3, and 24 hours after intervention

Change in neutrophil adhesion molecule (CD62L) expression over 24 hours from admission. Measured by flow cytometry using whole blood samples.

Endothelial Injury (Heparan Sulfate)

时间窗: 0 (Admission), 1, 3, and 24 hours after intervention

Change in plasma levels of endothelial injury marker Heparan Sulfate over 24 hours from Admission

Endothelial Injury (Hyaluronan)