Fibrinolytic Deficit in Patients With Acute Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Alpha-2 Antiplasmin level (A2P)
研究概览
简要总结
Fibrinolysis is the body's process that prevents blood clots. The investigators hypothesize that patients presenting with acute pulmonary embolism (PE) or blood clots in the lungs differ in their fibrinolytic deficit phenotype. The investigators aim to use biomarkers directly involved in endogenous fibrinolytic cascade including PAI-1, Alpha-2-Antiplasmin (A2A), TAFI, D-dimer, and Fibrinogen to phenotypically characterize patients presenting with acute PE and to correlate these biomarkers with clinical, echocardiographic, computed tomography (CT), and functional status outcomes.
详细描述
Patients (n=100) identified by the Pulmonary Embolism Response Team (PERT) suffering from a PE will be identified by the PI. Blood plasma samples from these patients which have been drawn for routine lab tests will be identified and the Sub-I who will pick the samples up from the clinical lab after the routine analysis has been completed. These samples will be de-identified by giving them a study number. These samples will be recentrifuged and aliquoted. Samples will be stored in a -80ᵒC freezer in the Hemostasis & Thrombosis Research Laboratory. When all 100 de-identified samples have been collected they will be analyzed blindly by the technical staff of the hemostasis laboratory for the fibrinolytic parameters PAI-1, Alpha-2-Antiplasmin, TAFI, tPA, D-dimer, Plasminogen, and Fibrinogen. PAI-1 and TAFI will be quantified with an Enzyme Linked-Immuno-Sorbent Assay (ELISA), while A2A is measured using functional assay. PAI-1 is measured as ug/ml, while TAFI and A2A are measured as % of normal controls. Normal controls are derived from pooled normal human plasma from volunteers purchased from outside vendor. Results will be compiled and sent to the PERT team for analysis and correlation withclinical, echocardiographic, computed tomography (CT), and functional status outcomes.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 18 - 90 years
- •Patients suffering an acute PE
- •Blood collected for clinical evaluation of PE
排除标准
- •Blood not collected or not sufficient quantity/quality
结局指标
主要结局
Alpha-2 Antiplasmin level (A2P)
时间窗: Baseline-Day 1
Laboratory analysis of blood sample for A2P level
Thrombin Activatable Fibrinolysis Inhibitor (TAFI)
时间窗: Baseline-Day 1
Laboratory analysis of blood sample for TAFI level
Fibrinogen
时间窗: Baseline-Day 1
Laboratory analysis of blood sample for Fibrinogen level
Clinical Presentation Risk Score
时间窗: Baseline-Day 1
Based on vital signs (heart rate, blood pressure, oxygen requirements, and labs (CBC, lactate, troponin, and BNP, clinical presentation will be characterized as low, intermediate, or high risk.
Right Ventricular Function
时间窗: Baseline-Day 1
Assessed by echocardiography
Cardiac Output
时间窗: Baseline-Day 1
Cardiac Output, the volume of blood pumped from the ventricle per heartbeat (mL/min), will be measured for patients escalated to endovascular therapies in the cardiac cath laboratory.
D-dimer
时间窗: Baseline-Day 1
Laboratory analysis of blood sample for D-dimer level
Pulmonary Artery Pressure
时间窗: Baseline-Day 1
Pulmonary Artery Pressure (mmHg) will be measured for patients escalated to endovascular therapies in the cardiac cath laboratory
Plasminogen Activator Inhibitor-1 (PAI-1)
时间窗: Baseline-Day 1
Laboratory analysis of blood sample for PAI-1 level
Tissue plasminogen activator (tPA)
时间窗: Baseline-Day 1
Laboratory analysis of blood sample for tPA level
Plasminogen
时间窗: Baseline-Day 1
Laboratory analysis of blood sample for Plasminogen level
次要结局
未报告次要终点
研究者
Amir Darki
Associate Professor
Loyola University