NCT04778917

Brief Summary

Objective 1\. Master the clinical feathers, imaging features and laboratory diagnosis characteristics and economic costs of children pneumonia with higher D-dimer:

  1. 1.Compare the characteristics of different groups of children in the course of the disease，clinicalsymptoms and signs;
  2. 2.All the children in the study need to do enhanced CT, to observe if there were intrapulmonary vascular thrombosis and necrosis pneumonia signs;
  3. 3.compared changes of coagulation index beside D-dimer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2020

Completed
12 months until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
Last Updated

March 3, 2021

Status Verified

February 1, 2021

Enrollment Period

2.6 years

First QC Date

March 19, 2020

Last Update Submit

February 28, 2021

Conditions

Pneumonia

Keywords

D-dimer,pneumonia,children

Outcome Measures

Primary Outcomes (4)

  • Lung imaging absorption improvement time after treatment

    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.

    Change from basline in lung imaging at 1 month

  • Time to improve cough symptoms

    The clinician will judge the improvement time of the child's cough symptoms

    2 weeks

  • Heat retreat time

    The time required for temperature to drop below 37.3℃ after treatment.

    2 weeks

  • The time to disappear rhonchus in the lungs

    The clinician will judge the absorption time of dry and wet rhonchus in the lungs.

    2 weeks

Secondary Outcomes (3)

  • Average hospital stay time

    2weeks to 4weeks

  • The degree of coagulation improvement

    2 weeks

  • Differences in inflammation indicators in each group

    basline

Study Arms (4)

Small dose low molecular weight heparin

EXPERIMENTAL

Low molecular weight heparin calcium 100 units / kg/day, subcutaneous injection, 5-10 days of treatment or D-dimer recovery normal.

Drug: Low-Molecular-Weight Heparins Calcium Injection

High dose of low molecular weight heparin

EXPERIMENTAL

low molecular weight heparin calcium 200 units /kg/day, subcutaneous injection, treatment for 7 days or D-dimer return to normal.

Drug: Low-Molecular-Weight Heparins Calcium Injection

Vacuity contrast group

PLACEBO COMPARATOR

Conventional treatment for children with pneumonia, without the use of low molecular weight heparin.

Drug: Low-Molecular-Weight Heparins Calcium Injection

contrast group

NO INTERVENTION

Conventional treatment for children with pneumonia, without the use of low molecular weight heparin.

Interventions

Low-Molecular-Weight Heparins Calcium InjectionDRUG

We use different dose of low-molecular-weight heparins calcium injection to different interventions

High dose of low molecular weight heparinSmall dose low molecular weight heparinVacuity contrast group

Eligibility Criteria

Age28 Days - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinical diagnosis of simple pneumonia
  • Age 28 days to 18 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Capital Institute of Pediatrics

Beijing, China

Location

Related Publications (8)

  • Esposito S, Cohen R, Domingo JD, Pecurariu OF, Greenberg D, Heininger U, Knuf M, Lutsar I, Principi N, Rodrigues F, Sharland M, Spoulou V, Syrogiannopoulos GA, Usonis V, Vergison A, Schaad UB. Antibiotic therapy for pediatric community-acquired pneumonia: do we know when, what and for how long to treat? Pediatr Infect Dis J. 2012 Jun;31(6):e78-85. doi: 10.1097/INF.0b013e318255dc5b.

    PMID: 22466326BACKGROUND

  • Schroeder JD, McKenzie AS, Zach JA, Wilson CG, Curran-Everett D, Stinson DS, Newell JD Jr, Lynch DA. Relationships between airflow obstruction and quantitative CT measurements of emphysema, air trapping, and airways in subjects with and without chronic obstructive pulmonary disease. AJR Am J Roentgenol. 2013 Sep;201(3):W460-70. doi: 10.2214/AJR.12.10102.

    PMID: 23971478BACKGROUND

  • Litmanovich DE, Hartwick K, Silva M, Bankier AA. Multidetector computed tomographic imaging in chronic obstructive pulmonary disease: emphysema and airways assessment. Radiol Clin North Am. 2014 Jan;52(1):137-54. doi: 10.1016/j.rcl.2013.09.002.

    PMID: 24267715BACKGROUND

  • Youn YS, Lee KY, Hwang JY, Rhim JW, Kang JH, Lee JS, Kim JC. Difference of clinical features in childhood Mycoplasma pneumoniae pneumonia. BMC Pediatr. 2010 Jul 6;10:48. doi: 10.1186/1471-2431-10-48.

    PMID: 20604923BACKGROUND

  • Madzhuga AV, Somonova OV, Elizarova AL, Sviridova SP, Zubrikhin GN. [The clinical value of D-dimer in the diagnosis and treatment of thromboembolic complications and DIC syndrome in cancer patients]. Anesteziol Reanimatol. 2005 Sep-Oct;(5):55-7. Russian.

    PMID: 16318055BACKGROUND

  • Zhao D, Ding R, Mao Y, Wang L, Zhang Z, Ma X. Heparin rescues sepsis-associated acute lung injury and lethality through the suppression of inflammatory responses. Inflammation. 2012 Dec;35(6):1825-32. doi: 10.1007/s10753-012-9503-0.

    PMID: 22782595BACKGROUND

  • Lankisch P, Laws HJ, Wingen AM, Borkhardt A, Niehues T, Neubert J. Association of nephrotic syndrome with immune reconstitution inflammatory syndrome. Pediatr Nephrol. 2012 Apr;27(4):667-9. doi: 10.1007/s00467-011-2069-5. Epub 2011 Dec 29.

    PMID: 22203364BACKGROUND

  • van der Poll T, de Boer JD, Levi M. The effect of inflammation on coagulation and vice versa. Curr Opin Infect Dis. 2011 Jun;24(3):273-8. doi: 10.1097/QCO.0b013e328344c078.

    PMID: 21330919BACKGROUND

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Ling Cao, MD

    Capital Institute of Pediatrics, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 3, 2021

Study Start

December 1, 2014

Primary Completion

July 1, 2017

Study Completion

February 1, 2018

Last Updated

March 3, 2021

Record last verified: 2021-02

Locations

CN(1)