Unfractionated Heparin in Acute Chest Syndrome: A Pilot Feasibility Randomized Controlled Trial of Unfractionated Heparin vs. Standard of Care in Acute Chest Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Craig Seaman
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Time to Hospital Discharge
研究概览
简要总结
The purpose of this study is to determine the feasibility of performing a larger multicenter phase III trial to assess the effects of unfractionated heparin (UFH) in acute chest syndrome (ACS). Prespecified feasibility criteria consists of the ability to enroll potential study participants, which includes the timely notification of hospitalized patients with ACS, the capacity to consent eligible individuals, and the ability to appropriately randomize eligible patients within 24 hours of diagnosis. Additional feasibility objectives involve ensuring appropriate eligibility criteria, proper administration of the study drug, and the ability to completely and accurately collect clinical data of interest. The final aim of our pilot study is to provide preliminary data, with respect to treatment effect and variance, to allow sample size calculation in a larger trial given the lack of data available to help guide this process. The investigators hypothesize that the use of UFH in ACS will result in a decrease in the duration of hospitalization and improve other clinical outcomes, such as the duration of hypoxemia and duration of moderate to severe pain.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ACS defined as a new pulmonary infiltrate involving at least one segment of the lung on a chest x-ray or chest CT scan with 2 or more of the following: chest pain, tachypnea, dyspnea, cough, hypoxemia, or body temperature greater than or equal to 38.0 degrees Celsius
- •Hemoglobin electrophoresis confirming HbSS, SC, or B0 (historical records sufficient)
- •Age greater than or equal to 18
排除标准
- •Any absolute contraindication to heparin
- •Platelet count less than 50 per microliter (current admission)
- •Historical diagnosis of moyamoya disease as documented in medical records
- •Historical diagnosis of proliferative retinopathy as documented in medical records
- •Current participation in a chronic exchange transfusion program
- •Underlying hypercoagulable disorder other than sickle cell disease
- •Currently receiving therappeutic anticoagulation
- •Currently receiving antiplatelet agents
- •Currently receiving estrogen containing oral contraceptives
- •Chest CT scan documented PE performed as standard of care prior to study enrollment (current admission)
研究组 & 干预措施
Unfractionated heparin
Subjects will be randomized within 24 hours of diagnosis to one of two treatment arms, Arm A, anticoagulation and standard of care, or Arm B, no anticoagulation and standard of care. Weight-adjusted UFH will be given at doses of 80 units per kilogram followed by 18 units per kilogram per hour intravenously for 7 days, or until discharge, if discharge is shorter than 7 days. UFH will be monitored by standard protocol to maintain the activated partial thromboplastin time in the therapeutic range per institutional guidelines.
The experimental arm will receive standard of care, too, which will include the following: intravenous fluids, antibiotics, supplemental oxygen, incentive spirometry, pain management, red blood cell transfusions, and exchange transfusions.
干预措施: Unfractionated heparin (Drug)
结局指标
主要结局
Time to Hospital Discharge
时间窗: Until hospital discharge
Duration of hospitalization
次要结局
- Duration of Hypoxemia Assessed by Arterial Oxygen Saturation(7 days)
- Percentage of Participants Transferred to Intensive Care Unit(7 days)
- Percentage of Participants Requiring Mechanical Ventilation(7 days)
- Duration of Fever Assessed by Body Temperature(7 days)
- Duration of Leukocytosis Assessed by White Blood Cell Count(7 days)
- Duration of Moderate to Severe Pain Assessed by Visual Analog Scale for Pain(7 days)
- Opioid Administration Per Participant(7 days)
- Units of Red Blood Cells Administered(7 days)
- Percentage of Participants Experiencing Multiorgan Dysfunction Syndrome(7 days)
研究者
Craig Seaman
Assistant Professor of Medicine
University of Pittsburgh