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LMWH for Pulmonary Microthrombosis in Childhood Pneumonia
NCT04778917Phase 4
Key facts
- Status
- Completed
- Start
- Dec 2014
- Primary completion
- Jul 2017
- Countries
- 1
- Sponsor
- Capital Institute of Pediatrics
- Modality
- Recombinant Proteins and Enzymes
- Conditions
- pneumonia
01
Overview
Phase 4, randomised, single-blind trial of low molecular weight heparin calcium in pneumonia (4 arms), sponsored by Capital Institute of Pediatrics. Primary endpoints: Lung imaging absorption improvement time after treatment at 1 month, Time to improve cough symptoms at 2 weeks and 2 more. Started Dec 2014; status: completed.
02
Design
4 arms- Study design
- RandomizedSingle-blind
Conventional (High D-dimer)
Conventional treatment without LMWH in patients with D-dimer >= 500 ug/L.
Low Dose LMWH
LMWH Calcium 50-100 units/kg/day in patients with D-dimer >= 500 ug/L.
High Dose LMWH
LMWH Calcium 200 units/kg/day (100 units/kg BID) in patients with D-dimer >= 500 ug/L.
Conventional (Low D-dimer)
Conventional treatment in patients with D-dimer < 500 ug/L.
03
Who it enrols
Children aged 28 days to 18 years with a clinical diagnosis of simple pneumonia. Patients with congenital heart disease, kidney disease, blood system diseases, paralysis, muscle tension, fracture, family history of thrombotic disease, indwelling central venous catheters, parenteral nutrition, neoplastic disease, or primary immunodeficiency disease are excluded.
04
Endpoints
Primary
Lung imaging absorption improvement time after treatment
Time to improve cough symptoms
Heat retreat time
The time to disappear rhonchus in the lungs
Secondary
Average hospital stay time
The degree of coagulation improvement
Differences in inflammation indicators in each group
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