PneumoniaPhase 4NCT04778917
Observation and Treatment of Pulmonary Microthrombosis in Childhood Pneumonia With Elevated D-dimer
A Phase 4 study testing Low-Molecular-Weight Heparins Calcium Injection in people with Pneumonia, run by Capital Institute of Pediatrics, China at 1 site in China.
Trial summary
Objective 1. Master the clinical feathers, imaging features and laboratory diagnosis characteristics and economic costs of children pneumonia with higher D-dimer: 1. Compare the characteristics of different groups of children in the course of the disease，clinicalsymptoms and signs; 2. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Pneumonia
- What is being tested?
- Low-Molecular-Weight Heparins Calcium Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Feb 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of simple pneumonia
- Age 28 days to 18 years
Who cannot join
- With congenital heart disease
- With kidney disease
- With blood system diseases
- With paralysis
- With muscle tension
- With fracture,
Show all 10Show fewer
- With a family history of thrombotic disease
- With indwelling central venous catheters
- With parenteral nutrition, neoplastic disease
- With primary immunodeficiency disease
Trial locations and contacts
1 site in 1 country.
About this study
Objective
- Master the clinical feathers, imaging features and laboratory diagnosis characteristics and economic costs of children pneumonia with higher D-dimer:
- Compare the characteristics of different groups of children in the course of the disease，clinicalsymptoms and signs;
- All the children in the study need to do enhanced CT, to observe if there were intrapulmonary vascular thrombosis and necrosis pneumonia signs;
- compared changes of coagulation index beside D-dimer.
- 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.
Read more
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.
Read the detailed description
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.
4.Study protocal:
Study group:
Group A :Conventional treatment for children with pneumonia, without the use of low molecular weight heparin.
Group B :Group B with prevention of DIC amount: low molecular weight heparin calcium 50-100 units / kg, once or twice subcutaneous injection, 5-10 days of treatment or D-Dimer recovery normal. According to Huang Ke, disseminated intravascular coagulation, Huang Shaoliang, Zhou Dunhua, editor in chief of pediatric hematology clinical manual, Third Edition, 601-602.
Group C :Group C with anticoagulant therapy: low molecular weight heparin calcium 100 units /kg, subcutaneous injection, two times a day, treatment for 7 days orD-Dimer return to normal. Low molecular weight heparin calcium.
Control group :Conventional treatment for children with pneumonia, without the use of low molecular weight heparin.
5.Statistical methods
Statistical analysis system(SAS).2 software was used for statistical analysis . The continuous variables of the central tendency and the discrete trend are represented by the median and the four point spacing, and the categorical variables are described by the constituent ratio. Normal distribution of continuous variables between the 22 comparison using T test, multiple comparisons using ANOVA. Non normal distribution of continuous variables between the 22 comparison using Rank Sum Test Wilcoxon, multiple comparisons using Kruskal-Wallis method. Statistical testing methods used properly. All the tests were taken by alpha =0.05.
6.Study objection:
- .Compare the group A with the control group of the clinical features
- . Compare all of the patients in the observation group with the control group of the chest CT features
- .To observe the efficacy and safety of anticoagulant therapy to children with D-dimer increased pneumonia
7.Sample size estimation：
As there is no evaluation of the efficacy of children with pneumonia combined with elevated D-Dimer in China, studies have shown that severe pneumonia is often accompanied by elevated D-Dimer. Therefore, this study only estimates the sample size based on the effective rate of heparin in the treatment of severe pneumonia. According to Wang Xuanzhu's research [Wang Xuanzhu. The efficacy of heparin in the treatment of severe pneumonia in children and its effect on platelet parameters and D-dimers], the effective rate of conventional methods in the treatment of severe pneumonia is 76.6%, and the effective rate of low-dose heparin treatment is 95.8%. This study adopts a two-sided test, taking α=0.05, β=0.20, u0.05/2=1.96, u0.2=0.8, p1=0.766, p2=0.958.Considering the possible loss to follow-up rate in this study is 10%, the sample size of each group should be: 31.
- Reporting for adverse events
Liver function, coagulation function, and platelet monitoring were performed for each child in the group. If there is a tendency to bleeding, the test was immediately terminated and corresponding treatment was given.
- Conditions
- Pneumonia
- Being tested
- Low-Molecular-Weight Heparins Calcium Injection
- Keywords
- D-dimer,pneumonia,children
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Molecular-Weight Heparins Calcium InjectionDrug
We use different dose of low-molecular-weight heparins calcium injection to different interventions
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 2 weeks
Heat retreat time
The time required for temperature to drop below 37.3℃ after treatment.
Measured: 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.
Measured: 2 weeks
Secondary outcomes (3)
Average hospital stay time
The time required from the child's admission to the improvement and discharge
Measured: 2weeks to 4weeks
The degree of coagulation improvement
Laboratory test indicators include: platelet count (PLT), prothrombin time, partial thromboplastin time Prothrombin time（PT）\Activated partial thromboplastin time（APTT）, protein fiber, fiber protein degradation product Fibrinogen（FIB）\Fibrinogen degradation products（FDP）, D-dimer, Antithrombin III（AT-III）.Compare the improvement degree of the above indicators in each group before and after treatment.
Measured: 2 weeks
Differences in inflammation indicators in each group
The inflammatory markers included CRP, ESR and WBC counts.
Measured: basline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study startDec 2014
- Primary completionJul 2017
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Institute of Pediatrics, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ling Cao, MD, Principal investigator, Capital Institute of Pediatrics, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778917
- Sponsor's protocol ID
- W12-1
- Status last verified
- Feb 2021
- First submitted
- 19 Mar 2020
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22466326Schroeder 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.
PubMed 23971478Litmanovich 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.
PubMed 24267715Youn 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.
PubMed 20604923Madzhuga 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.
PubMed 16318055Zhao 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.
PubMed 22782595Lankisch 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.
PubMed 22203364van 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.
PubMed 21330919
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation and Treatment of Pulmonary Microthrombosis in Childhood Pneumonia With Elevated D-dimer
- ClinicalTrials.gov ID
- NCT04778917
- Acronym / sponsor ID
- W12-1
- Conditions
- Pneumonia
- Keywords
- D-dimer,pneumonia,children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Capital Institute of Pediatrics, ChinaUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective
- Master the clinical feathers, imaging features and laboratory diagnosis characteristics and economic costs of children pneumonia with higher D-dimer:
- Compare the characteristics of different groups of children in the course of the disease，clinicalsymptoms and signs;
- All the children in the study need to do enhanced CT, to observe if there were intrapulmonary vascular thrombosis and necrosis pneumonia signs;
- compared changes of coagulation index beside D-dimer.
- 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.
Detailed description
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.
4.Study protocal:
Study group:
Group A :Conventional treatment for children with pneumonia, without the use of low molecular weight heparin.
Group B :Group B with prevention of DIC amount: low molecular weight heparin calcium 50-100 units / kg, once or twice subcutaneous injection, 5-10 days of treatment or D-Dimer recovery normal. According to Huang Ke, disseminated intravascular coagulation, Huang Shaoliang, Zhou Dunhua, editor in chief of pediatric hematology clinical manual, Third Edition, 601-602.
Group C :Group C with anticoagulant therapy: low molecular weight heparin calcium 100 units /kg, subcutaneous injection, two times a day, treatment for 7 days orD-Dimer return to normal. Low molecular weight heparin calcium.
Control group :Conventional treatment for children with pneumonia, without the use of low molecular weight heparin.
5.Statistical methods
Statistical analysis system(SAS).2 software was used for statistical analysis . The continuous variables of the central tendency and the discrete trend are represented by the median and the four point spacing, and the categorical variables are described by the constituent ratio. Normal distribution of continuous variables between the 22 comparison using T test, multiple comparisons using ANOVA. Non normal distribution of continuous variables between the 22 comparison using Rank Sum Test Wilcoxon, multiple comparisons using Kruskal-Wallis method. Statistical testing methods used properly. All the tests were taken by alpha =0.05.
6.Study objection:
- .Compare the group A with the control group of the clinical features
- . Compare all of the patients in the observation group with the control group of the chest CT features
- .To observe the efficacy and safety of anticoagulant therapy to children with D-dimer increased pneumonia
7.Sample size estimation：
As there is no evaluation of the efficacy of children with pneumonia combined with elevated D-Dimer in China, studies have shown that severe pneumonia is often accompanied by elevated D-Dimer. Therefore, this study only estimates the sample size based on the effective rate of heparin in the treatment of severe pneumonia. According to Wang Xuanzhu's research [Wang Xuanzhu. The efficacy of heparin in the treatment of severe pneumonia in children and its effect on platelet parameters and D-dimers], the effective rate of conventional methods in the treatment of severe pneumonia is 76.6%, and the effective rate of low-dose heparin treatment is 95.8%. This study adopts a two-sided test, taking α=0.05, β=0.20, u0.05/2=1.96, u0.2=0.8, p1=0.766, p2=0.958.Considering the possible loss to follow-up rate in this study is 10%, the sample size of each group should be: 31.
- Reporting for adverse events
Liver function, coagulation function, and platelet monitoring were performed for each child in the group. If there is a tendency to bleeding, the test was immediately terminated and corresponding treatment was given.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Small dose low molecular weight heparin | Experimental | Drug: Low-Molecular-Weight Heparins Calcium InjectionLow molecular weight heparin calcium 100 units / kg/day, subcutaneous injection, 5-10 days of treatment or D-dimer recovery normal. |
| High dose of low molecular weight heparin | Experimental | Drug: Low-Molecular-Weight Heparins Calcium Injectionlow molecular weight heparin calcium 200 units /kg/day, subcutaneous injection, treatment for 7 days or D-dimer return to normal. |
| Vacuity contrast group | Placebo comparator | Drug: Low-Molecular-Weight Heparins Calcium InjectionConventional treatment for children with pneumonia, without the use of low molecular weight heparin. |
| contrast group | No intervention | –Conventional treatment for children with pneumonia, without the use of low molecular weight heparin. |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of simple pneumonia
- Age 28 days to 18 years
Key exclusion criteria (10 listed)
- With congenital heart disease
- With kidney disease
- With blood system diseases
- With paralysis
- With muscle tension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-Molecular-Weight Heparins Calcium InjectionWe use different dose of low-molecular-weight heparins calcium injection to different interventions | Drug | High dose of low molecular weight heparin, Small dose low molecular weight heparin, Vacuity contrast group |
Primary outcome
Lung imaging absorption improvement time after treatment
Time frame: 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.
Time to improve cough symptoms
Time frame: 2 weeks
The clinician will judge the improvement time of the child's cough symptoms
Heat retreat time
Time frame: 2 weeks
The time required for temperature to drop below 37.3℃ after treatment.
The time to disappear rhonchus in the lungs
Time frame: 2 weeks
The clinician will judge the absorption time of dry and wet rhonchus in the lungs.
3 secondary outcomes
Average hospital stay time
Time frame: 2weeks to 4weeks
The degree of coagulation improvement
Time frame: 2 weeks
Differences in inflammation indicators in each group
Time frame: basline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Background: PubMed 22466326Esposito 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.
- Background: PubMed 23971478Schroeder 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.
- Background: PubMed 24267715Litmanovich 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.
- Background: PubMed 20604923Youn 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.
- Background: PubMed 16318055Madzhuga 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.
- Background: PubMed 22782595Zhao 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.
- Background: PubMed 22203364Lankisch 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.
- Background: PubMed 21330919van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ling Cao, MD principal investigator
Capital Institute of Pediatrics, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low-Molecular-Weight Heparins Calcium Injection in people with Pneumonia, run by Capital Institute of Pediatrics, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung imaging absorption improvement time after treatment (time frame: Change from basline in lung imaging at 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04778917, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.