Observation and Treatment of Pulmonary Microthrombosis in Childhood Pneumonia With Elevated D-dimer
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Time to improve cough symptoms
研究概览
简要总结
Objective
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Master the clinical feathers, imaging features and laboratory diagnosis characteristics and economic costs of children pneumonia with higher D-dimer:
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Compare the characteristics of different groups of children in the course of the disease，clinicalsymptoms and signs;
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All the children in the study need to do enhanced CT, to observe if there were intrapulmonary vascular thrombosis and necrosis pneumonia signs;
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compared changes of coagulation index beside D-dimer.
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Compared with low molecular weight heparin prevention Disseminated intravascular coagulation（DIC） dose and instructions to the recommended dose in safety and effectiveness,and proposed elevated anticoagulation D-Dimer specification of the clinical treatment of children with pneumonia.
Background and rationale:
Pneumonia is the main cause of lung function injury and death in children. The high blood coagulation state can lead to the formation of pulmonary vascular thrombosis, local pulmonary ischemia and necrosis, which may be an important mechanism for the occurrence of necrotizing pneumonia and pulmonary embolism in children with pneumonia. Elevated D-dimer is an important predictor of pulmonary thrombosis and necrotizing pneumonia. At present, D-Dimer in many children with severe pneumonia is found to increase, the symptom is severe, the late stage of the performance of necrotizing pneumonia, seriously affect the children's lung function and quality of life.
详细描述
This is a randomized, controlled, single blind trial(Researchers are not blind, patients are blind).
1.Patient population
- .Experience group We will recruit 93 cases in our trial.All of them are with simple pneumonia and are hospitalized in the respiratory department of our hospital, also D-dimer is higher than or equal to 500ug / L, 93 cases as the observation group, were randomly divided into A, B, C three sub group.
- .Control group We will recruit 31 cases in our control group.And children in this group are also with simple pneumonia,they will be similar with the experience group children at the age, the disease course but their D-Dimer is lower than 500 ug/L.
2.Randomized methods: A random number table was created by the statistical staff of the non-present research group using SAS to generate random numbers table before the start of the study. Selected children are in accordance with the A, B, C three groups of 1:1:1 ratio distribution.
3.Study method: Fasting venous blood was extracted from all the children from the second morning after admission to complete the coagulation function, blood routine, biochemical and related inflammatory indicators and complete chest CT examination。The above indicators were monitored dynamically during hospitalization.
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 (Participant)
入排标准
- 年龄范围
- 28 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of simple pneumonia
- •Age 28 days to 18 years
排除标准
- •With congenital heart disease
- •With kidney disease
- •With blood system diseases
- •With paralysis
- •With muscle tension
- •With fracture,
- •With a family history of thrombotic disease
- •With indwelling central venous catheters
- •With parenteral nutrition, neoplastic disease
- •With primary immunodeficiency disease
研究组 & 干预措施
Small dose low molecular weight heparin
Low molecular weight heparin calcium 100 units / kg/day, subcutaneous injection, 5-10 days of treatment or D-dimer recovery normal.
干预措施: Low-Molecular-Weight Heparins Calcium Injection (Drug)
High dose of low molecular weight heparin
low molecular weight heparin calcium 200 units /kg/day, subcutaneous injection, treatment for 7 days or D-dimer return to normal.
干预措施: Low-Molecular-Weight Heparins Calcium Injection (Drug)
Vacuity contrast group
Conventional treatment for children with pneumonia, without the use of low molecular weight heparin.
干预措施: Low-Molecular-Weight Heparins Calcium Injection (Drug)
结局指标
主要结局
Time to improve cough symptoms
时间窗: 2 weeks
The clinician will judge the improvement time of the child's cough symptoms
Heat retreat time
时间窗: 2 weeks
The time required for temperature to drop below 37.3℃ after treatment.
The time to disappear rhonchus in the lungs
时间窗: 2 weeks
The clinician will judge the absorption time of dry and wet rhonchus in the lungs.
Lung imaging absorption improvement time after treatment
时间窗: Change from basline in lung imaging at 1 month
The enrolled children were subjected to weekly imaging examinations to determine the time for the absorption of lung inflammation to improve.Criteria for evaluating the severity of CT changes (large lung shadows or dot shadows in CT images) : Criteria for improvement of lung imaging absorption: no obvious lesion absorption, no absorption or large patchy shadow; Partial absorption of lesions: there is absorption, but there is still patchy shadow or cloud flocculent shadow; Obvious absorption of lesions: no abnormalities or only a little light in the lung.
次要结局
- Differences in inflammation indicators in each group(basline)
- Average hospital stay time(2weeks to 4weeks)
- The degree of coagulation improvement(2 weeks)